Post Traumatic Stress Disorders
Conditions
Keywords
Post Traumatic Stress Disorder, Service Dog, Emotional Support Dog
Brief summary
Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field.
Detailed description
Background: Service Dogs are trained to assist people with disabilities to accomplish tasks which permit the individual to be more functional in their home and social environment. Often the dogs are trained to help in the completion of activities of daily living and instrumental activities of daily living. Service Dogs are efficacious for individuals with disabilities, such as vision limitations, spinal cord injury and hearing problems. In addition, some mental health outcomes have improved with the introduction of a Service Dog. A research study was mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies Program, the proponents have designed a research study to effectively meet the demands of the Bill and to provide timely research into an evolving field. Study Primary Objective: To examine how limitations on activity and quality of life in Veterans with PTSD are impacted by the provision of a Service Dog versus an Emotional Support Dog. Study Design: A prospective randomized study is proposed which has two randomized arms. Arm one of the study will be Veterans (n=110) randomized and paired with a Service Dog, which has been trained in 5 PTSD-specific tasks to assist with the Veteran's PTSD issues. Arm two (n=110) of the study will be Veterans randomized and paired with an Emotional Support Dog (a dog that provides support via emotional comfort). All Veterans, after confirmation of eligibility, will be randomized to receive a Service Dog or Emotional Support Dog and will be observed for a minimum of three months prior to receiving their dog. During this observation period, Veterans will be required to participate in a Dog Care Course to ensure they are aware of the demands dogs place on humans. Once a dog becomes available, the Veteran will be paired with a Service Dog or Emotional Support Dog. Pairing is the training process in which the Veteran is given instruction and practice in commanding and caring for their new service dog or emotional support dog. The pairing process for a service dog takes place at the contracted dog vendor's location; the pairing process for an emotional support dog takes place at the Veteran's home, facilitated by a VA Dog Trainer. Follow-up with the Veteran begins one week post pairing to track any dog behavior issues, and will continue after pairing for 18 months. Primary outcomes to be examined include limitations on Veteran activity (as measured by the WHO-DAS 2.0) and quality of life (measured by the VR-12). Secondary outcomes include PTSD symptoms (measured by the PCL-5), suicidal ideation (C-SSRS); depression (PHQ-9) and Sleep (PSQI). In addition, health care utilization, anger management (DAR), employment, and work productivity will also be examined. Study outcomes are assessed at baseline (prior to randomization), and at 3-month intervals after a Veteran is paired with a dog until 18 months post pairing. This multi-site study will be conducted at three locations nationwide.
Interventions
OTHEREmotional Support Dogs
Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.
OTHERService Dogs
Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males and Females greater than\> 18 years of age. 2. Referral from Mental Health provider that documents PTSD. 3. PTSD as a result of any trauma as determined by meeting DSM 5 diagnostic criteria. 4. Enrolled in mental health services at VA and has attended at least one visit in the 90 days prior to consent. * If individual not currently enrolled in mental health treatment decides to enroll in such then he/she may become eligible to participate in the study. * If individual enrolled in mental health treatment schedules and attends a mental health visit then he/she may become eligible to participate in the study. 5. Agrees to remain in mental health treatment throughout the duration of the study 6. Can adequately care for a dog . * Adequately caring for a dog requires that participants will be responsible for and able to provide food, water, protection, shelter, exercise, transportation, and treatment related to their assigned dog. * Adequately handling the dog means having the ability to give and reinforce obedience commands and control the dog using a leash. 7. Home environment is suitable for a dog. * If the home environment can be remedied the potential participant may become eligible to participate in the study. * If a participant moves home while enrolled in the study the new home must be suitable for a dog. 8. Home environment is structurally and geographically accessible to study staff. * If the home is geographically inaccessible to study staff and, the individual cannot remedy the situation unless he/she moves home. The study team will not encourage this. If a move takes place, it will be the individual's responsibility to re-contact the study team. * If the individual changes home residence while enrolled in the study, the new home must be geographically accessible to study staff. If it is inaccessible, the dog will be removed and the individual will be withdrawn from the study. 9. Is willing to accept randomization outcome. 10. Has someone to care for dog during extended absence of the participant. * If no one is available to care for the dog but the situation changes then the participant may become eligible to participate. 11. Others in home are agreeable to having dog. * If others in the home are not agreeable but at a later date the situation changes, then the potential participant may become eligible to participate. 12. Is willing and able to travel (by air or car) to training site for pairing. * If potential participant's unwillingness to travel to a training site changes, he/she may become eligible to participate. In this instance, it will be the individual's responsibility to re-contact the study team. 13. Individual has no household pets that would threaten the bonding and obedience training of an assigned study dog. * If a household dog lives inside the home and the home is partitioned such that there are two or more separate living spaces served by independent entrance/exits, and the individual does not live in a partition with a dog, then the individual can be eligible. If a household dog lives primarily outside the home in a rural area and the individual is not primarily responsible for feeding the dog on a daily basis, then the individual can be eligible. * If an individual has pets other than dogs that could interfere with bonding, the individual will be scheduled for the screening visits and the relationship will be assessed by the dog trainer. * If an individual has a household dog or other pet that prevents participation in the study but the situation changes, the individual may become eligible to participate. In this instance, it will be the individual's responsibility to re-contact the study team. 14. Individual can verbalize understanding of consent form, is willing to provide written informed consent and to follow study procedures.
Exclusion criteria
1. Hospitalization for mental health reasons in the past 6 months. * Once six months since hospitalization have passed, the individual may become eligible to participate in the study. 2. Aggressive behavior that would make it unsafe for dog. 3. Diagnosis of psychosis, delusions, dementia, moderate or severe alcohol/substance disorder (SUD), or moderate to severe traumatic brain injury as determined by the presence or absence of a condition following scoring of MINI responses or as documented in chart notes. SUD assessment (alcohol/non-alcohol): * Ineligibility is based on the presence of a Moderate (4-5 symptoms) to Severe (6+ symptoms) SUD as identified by the MINI within the previous 12-month period starting from date of the study MINI screening. * If a Moderate to Severe SUD has been documented or communicated by the referring clinician or potential participant, or is noted in the EMR prior to the initial MINI screening visit, individuals should be scheduled for their initial screening visit on a timeline commensurate with meeting the 12-month SUDs eligibility window. * If an individual is identified as ineligible during the initial screening visit (i.e. MINI SUDs score ≥4) he/she may be re-evaluated later at the discretion of the study team. Re-evaluations should be scheduled based on a timeline commensurate with meeting the 12-month SUDs eligibility window (absence of a Moderate to Severe SUD for the previous 12 months). If at re-evaluation the individual has \<4 symptoms, he/she may become eligible to participate in the study. 4. Active suicidal intent as determined by a CPRS flag for suicidal intent or an endorsement of yes to question 5 (active suicidal ideation with specific plan and intent) on the C-SSRS completed at the Clinic Qualifying Visit. * An endorsement of yes to question 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) without endorsement of question 5 indicates that the individual needs additional assessment to determine eligibility. 5. Homicidal intent or cognitive disabilities that would preclude safety of dog and/or ability to participate in the study. 6. Social, mental or physical condition that prevents the potential participant from either giving informed consent or participating in the study. 7. Participation in another unapproved research trial. * If the individual is in another unrelated study and both the study Chair/PI of this and the other study consider participation in both studies to be acceptable then the individual may become eligible to participate in this study. * If the study Chair/PI of this and/or the other study consider participation in both studies to be unacceptable then, once participation in the other study is complete, the participant may become eligible to participate in this study. At that time, it will be the individual's responsibility to re-contact the study team. 8. Has chart note flag for violent/disruptive behavior. 9. Potential participants who are pregnant/who have a partner who is pregnant, or who currently have one or more children younger than age 5 in the household for more than 8 hours per day, one day a week will be excluded from the study. * If a participant or anyone else in the household becomes pregnant during the observation period, the participant will be excluded from the study. * Participants who have children in their home/become pregnant after being paired with a dog will be evaluated on a case-by-case basis (see Safety Monitoring of Children in the Home below). * After a total of 10 dogs have been placed with participants who have children between the ages of 5 and 10 years, and after each pairing has successfully reached and passed the 2-month home visit, this exclusion criterion will be revisited for potential inclusion of participants with children younger than 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012). |
| Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. |
| Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dimensions of Anger Reactions (DAR) Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition. |
| Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a Yes response to any one of the five suicidal behavior or the five suicidal ideation questions. |
| Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline and every 3 months after dog pairing up to 18 months post-pairing | Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. |
| Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Baseline and every 3 months after dog pairing up to 18 months post-pairing | Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. |
| Percentage of Participants With a Non-VA Hospitalization | Baseline and every 3 months after dog pairing up to 18 months post-pairing | Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection. |
| Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | 540 days starting on the pairing date; summarized into six 90-day periods | Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. |
| Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | 540 days starting on the pairing date; summarized into six 90-day periods | Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. |
| Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | 540 days starting on the pairing date; summarized into six 90-day periods | Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. |
| Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality. |
| Total Cost of VA Healthcare (Inpatient and Outpatient) | 540 days starting on the pairing date; summarized into six 90-day periods | Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. |
| Percentage of Days Covered for Antidepressants | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage). |
| Percentage of Days Covered for Antipsychotics | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage). |
| Percentage of Days Covered for Benzodiazepines | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage). |
| Percentage of Days Covered for Other Sedatives | Baseline: The 540 days prior to pairing Follow up: Pairing through day 540 | The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage). |
| Number of Veterans Employed | Baseline and every 3 months after dog pairing up to 18 months post-pairing | Employment assessed using the question Are you currently employed (working for pay)? from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection. |
| Impact of Health on Work Productivity Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity. |
| Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | 540 days starting on the pairing date; summarized into six 90-day periods | Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods. |
| Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity. |
| Patient Health Questionnaire (PHQ-9) Score | Baseline and every 3 months after dog pairing up to 18 months post-pairing | The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity). |
Countries
United States
Participant flow
Pre-assignment details
Sixty participants of 287 consented participants were found to be ineligible for study randomization per study inclusion/exclusion criteria, resulting in 227 participants randomized.
Participants by arm
| Arm | Count |
|---|---|
| Emotional Support Dog Participants paired with Emotional Support Dogs
Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized. | 84 |
| Service Dogs Participants paired with Service Dogs
Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, & behind). | 97 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Pairing With a Study Dog | Death | 1 | 0 |
| Pairing With a Study Dog | Lost to Follow-up | 1 | 4 |
| Pairing With a Study Dog | Other reasons for not completing study | 13 | 4 |
| Pairing With a Study Dog | Withdrawal by Subject | 4 | 1 |
| Randomization and Observation Period | Adverse Event | 2 | 0 |
| Randomization and Observation Period | Death | 1 | 0 |
| Randomization and Observation Period | Lost to Follow-up | 2 | 3 |
| Randomization and Observation Period | Other reasons not paired with a study dog | 22 | 11 |
| Randomization and Observation Period | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Service Dogs | Total | Emotional Support Dog |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 13.87 | 50.6 years STANDARD_DEVIATION 13.61 | 49.2 years STANDARD_DEVIATION 13.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 165 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 68 Participants | 120 Participants | 52 Participants |
| Sex: Female, Male Female | 22 Participants | 36 Participants | 14 Participants |
| Sex: Female, Male Male | 75 Participants | 145 Participants | 70 Participants |
| Veterans Rand 12-Item Health Survey - Mental Component Score (VR-12 MCS) | 30.68 T-score STANDARD_DEVIATION 10.37 | 30.88 T-score STANDARD_DEVIATION 10.46 | 31.11 T-score STANDARD_DEVIATION 10.62 |
| Veterans Rand 12-Item Health Survey - Physical Component Score (VR-12 PCS) | 43.07 T-score STANDARD_DEVIATION 11.2 | 41.73 T-score STANDARD_DEVIATION 10.71 | 40.16 T-score STANDARD_DEVIATION 9.94 |
| World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) | 35.78 units on a scale STANDARD_DEVIATION 16.72 | 36.95 units on a scale STANDARD_DEVIATION 16.5 | 38.31 units on a scale STANDARD_DEVIATION 16.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 84 | 0 / 97 | 1 / 287 |
| other Total, other adverse events | 5 / 84 | 0 / 97 | 1 / 287 |
| serious Total, serious adverse events | 21 / 84 | 18 / 97 | 18 / 287 |
Outcome results
Primary
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS)
The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 6 | 36.71 T-score | Standard Deviation 11.3 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 12 | 37.32 T-score | Standard Deviation 10.66 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 3 | 35.59 T-score | Standard Deviation 10.32 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 15 | 36.42 T-score | Standard Deviation 10.15 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 9 | 34.53 T-score | Standard Deviation 10.59 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 18 | 39.04 T-score | Standard Deviation 12.35 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Baseline | 31.11 T-score | Standard Deviation 10.62 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 18 | 40.28 T-score | Standard Deviation 9.33 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Baseline | 30.68 T-score | Standard Deviation 10.37 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 3 | 35.81 T-score | Standard Deviation 9.07 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 6 | 35.71 T-score | Standard Deviation 8.91 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 9 | 36.39 T-score | Standard Deviation 9.92 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 12 | 36.98 T-score | Standard Deviation 10.83 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) | Month 15 | 37.72 T-score | Standard Deviation 11.4 |
p-value: 0.606Mixed Models Analysis
Primary
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS)
The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 18 | 37.30 T-score | Standard Deviation 11.6 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 3 | 37.14 T-score | Standard Deviation 10.86 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Baseline | 40.16 T-score | Standard Deviation 9.94 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 6 | 35.78 T-score | Standard Deviation 10.83 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 9 | 35.35 T-score | Standard Deviation 11.32 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 12 | 35.73 T-score | Standard Deviation 12.52 |
| Emotional Support Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 15 | 35.78 T-score | Standard Deviation 11.42 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Baseline | 43.07 T-score | Standard Deviation 11.2 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 9 | 39.07 T-score | Standard Deviation 11.65 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 18 | 38.52 T-score | Standard Deviation 11.71 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 15 | 39.48 T-score | Standard Deviation 11.43 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 3 | 39.05 T-score | Standard Deviation 11.08 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 12 | 38.89 T-score | Standard Deviation 11.44 |
| Service Dogs | Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) | Month 6 | 39.80 T-score | Standard Deviation 11.59 |
p-value: 0.421Mixed Models Analysis
Primary
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score
The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012).
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 6 | 41.70 score on a scale | Standard Deviation 17.62 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 12 | 40.79 score on a scale | Standard Deviation 17.36 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 3 | 41.76 score on a scale | Standard Deviation 16.89 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 15 | 43.48 score on a scale | Standard Deviation 17.83 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 9 | 43.07 score on a scale | Standard Deviation 18.74 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 18 | 38.05 score on a scale | Standard Deviation 17.79 |
| Emotional Support Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Baseline | 38.31 score on a scale | Standard Deviation 16.23 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 18 | 33.43 score on a scale | Standard Deviation 17.38 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Baseline | 35.78 score on a scale | Standard Deviation 16.72 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 3 | 38.76 score on a scale | Standard Deviation 16.46 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 6 | 36.73 score on a scale | Standard Deviation 16.33 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 9 | 36.90 score on a scale | Standard Deviation 17.29 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 12 | 36.76 score on a scale | Standard Deviation 17.23 |
| Service Dogs | World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score | Month 15 | 36.16 score on a scale | Standard Deviation 17.69 |
p-value: 0.052Mixed Models Analysis
Secondary
Dimensions of Anger Reactions (DAR) Score
The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 9 | 23.97 score on a scale | Standard Deviation 16.16 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Baseline | 23.82 score on a scale | Standard Deviation 14.64 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 12 | 22.97 score on a scale | Standard Deviation 15.57 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 15 | 22.32 score on a scale | Standard Deviation 16.91 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 6 | 21.05 score on a scale | Standard Deviation 16.32 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 18 | 20.15 score on a scale | Standard Deviation 16.63 |
| Emotional Support Dogs | Dimensions of Anger Reactions (DAR) Score | Month 3 | 23.21 score on a scale | Standard Deviation 15.87 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 18 | 15.90 score on a scale | Standard Deviation 14.37 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Baseline | 21.85 score on a scale | Standard Deviation 15.07 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 3 | 22.14 score on a scale | Standard Deviation 14.28 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 6 | 20.35 score on a scale | Standard Deviation 13.75 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 9 | 19.52 score on a scale | Standard Deviation 13.22 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 15 | 17.47 score on a scale | Standard Deviation 14.24 |
| Service Dogs | Dimensions of Anger Reactions (DAR) Score | Month 12 | 18.58 score on a scale | Standard Deviation 14.75 |
p-value: 0.155Mixed Models Analysis
Secondary
Impact of Health on Work Productivity Score
Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 6 | 4.1 score on a scale | Standard Deviation 2.7 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 12 | 3.1 score on a scale | Standard Deviation 2.6 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 3 | 4.7 score on a scale | Standard Deviation 2.6 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 15 | 3.6 score on a scale | Standard Deviation 2.2 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 9 | 3.9 score on a scale | Standard Deviation 2.9 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Month 18 | 2.7 score on a scale | Standard Deviation 2.2 |
| Emotional Support Dogs | Impact of Health on Work Productivity Score | Baseline | 5.7 score on a scale | Standard Deviation 2.6 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 18 | 3.7 score on a scale | Standard Deviation 2.3 |
| Service Dogs | Impact of Health on Work Productivity Score | Baseline | 3.3 score on a scale | Standard Deviation 2.2 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 3 | 3.4 score on a scale | Standard Deviation 2.8 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 6 | 3.1 score on a scale | Standard Deviation 2.9 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 9 | 2.7 score on a scale | Standard Deviation 2.8 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 12 | 3.4 score on a scale | Standard Deviation 2.6 |
| Service Dogs | Impact of Health on Work Productivity Score | Month 15 | 3 score on a scale | Standard Deviation 2.9 |
p-value: 0.932Regression, Linear
Secondary
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities
Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 6 | 0.1 number of visits | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 12 | 0.1 number of visits | Standard Deviation 0.4 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 3 | 0.1 number of visits | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 15 | 0.1 number of visits | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 9 | 0.1 number of visits | Standard Deviation 0.6 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 18 | 0.1 number of visits | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Baseline | 0.1 number of visits | Standard Deviation 0.4 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 18 | 0.1 number of visits | Standard Deviation 0.3 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Baseline | 0.1 number of visits | Standard Deviation 0.3 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 3 | 0.0 number of visits | Standard Deviation 0.2 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 6 | 0.0 number of visits | Standard Deviation 0.2 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 9 | 0.1 number of visits | Standard Deviation 0.3 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 12 | 0.1 number of visits | Standard Deviation 0.3 |
| Service Dogs | Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities | Month 15 | 0.0 number of visits | Standard Deviation 0.2 |
p-value: 0.358Regression, Linear
Secondary
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 0 Number of inpatient admissions | Standard Deviation 0.2 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 0 Number of inpatient admissions | Standard Deviation 0.1 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 0 Number of inpatient admissions | Standard Deviation 0.1 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 0.1 Number of inpatient admissions | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 0 Number of inpatient admissions | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 451-540 | 0 Number of inpatient admissions | Standard Deviation 0.3 |
| Emotional Support Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 0 Number of inpatient admissions | Standard Deviation 0.1 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 451-540 | 0 Number of inpatient admissions | Standard Deviation 0.1 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 0.1 Number of inpatient admissions | Standard Deviation 0.3 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 0.1 Number of inpatient admissions | Standard Deviation 0.3 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 0 Number of inpatient admissions | Standard Deviation 0.2 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 0.1 Number of inpatient admissions | Standard Deviation 0.3 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 0 Number of inpatient admissions | Standard Deviation 0.2 |
| Service Dogs | Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 0.1 Number of inpatient admissions | Standard Deviation 0.4 |
Secondary
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 6 | 1.0 number of visits | Standard Deviation 2.8 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 12 | 0.9 number of visits | Standard Deviation 2.7 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 3 | 0.9 number of visits | Standard Deviation 2.6 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 15 | 1.4 number of visits | Standard Deviation 3.3 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 9 | 1.3 number of visits | Standard Deviation 3.5 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 18 | 0.9 number of visits | Standard Deviation 2.1 |
| Emotional Support Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline | 1.6 number of visits | Standard Deviation 3.8 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 18 | 0.6 number of visits | Standard Deviation 1.8 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline | 1.1 number of visits | Standard Deviation 4.8 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 3 | 0.5 number of visits | Standard Deviation 1.3 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 6 | 0.4 number of visits | Standard Deviation 1.4 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 9 | 0.5 number of visits | Standard Deviation 1.5 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 12 | 0.7 number of visits | Standard Deviation 2.5 |
| Service Dogs | Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Month 15 | 0.5 number of visits | Standard Deviation 1.5 |
p-value: 0.43Regression, Linear
Secondary
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers.
Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Population: Participants randomized and paired with an emotional support dog or a service dog.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 91-180 | 14.5 number of visits | Standard Deviation 9.1 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 271-360 | 13.4 number of visits | Standard Deviation 8.5 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 1-90 | 15.1 number of visits | Standard Deviation 9.3 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 361-450 | 14.2 number of visits | Standard Deviation 8.7 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 181-270 | 14.5 number of visits | Standard Deviation 10.1 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 451-540 | 14.8 number of visits | Standard Deviation 10.7 |
| Emotional Support Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Baseline (90 days prior to pairing) | 16.4 number of visits | Standard Deviation 9.1 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 451-540 | 13 number of visits | Standard Deviation 9.8 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Baseline (90 days prior to pairing) | 15.2 number of visits | Standard Deviation 10.6 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 1-90 | 15.1 number of visits | Standard Deviation 11.3 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 91-180 | 15 number of visits | Standard Deviation 9.8 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 181-270 | 14.4 number of visits | Standard Deviation 11.2 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 271-360 | 13.4 number of visits | Standard Deviation 9.8 |
| Service Dogs | Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. | Days 361-450 | 13.8 number of visits | Standard Deviation 10.5 |
Secondary
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS)
The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a Yes response to any one of the five suicidal behavior or the five suicidal ideation questions.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 6 | 19 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 12 | 20 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 3 | 22 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 15 | 21 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 9 | 19 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 18 | 18 Participants |
| Emotional Support Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline | 13 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 18 | 13 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline | 24 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 3 | 33 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 6 | 21 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 9 | 22 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 12 | 25 Participants |
| Service Dogs | Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) | Month 15 | 20 Participants |
p-value: 0.157Mixed Models Analysis
Secondary
Number of Veterans Employed
Employment assessed using the question Are you currently employed (working for pay)? from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Emotional Support Dogs | Number of Veterans Employed | Month 18 | 17 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Baseline | 28 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Month 3 | 27 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Month 6 | 23 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Month 9 | 20 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Month 12 | 19 Participants |
| Emotional Support Dogs | Number of Veterans Employed | Month 15 | 18 Participants |
| Service Dogs | Number of Veterans Employed | Month 18 | 21 Participants |
| Service Dogs | Number of Veterans Employed | Month 9 | 22 Participants |
| Service Dogs | Number of Veterans Employed | Baseline | 25 Participants |
| Service Dogs | Number of Veterans Employed | Month 15 | 25 Participants |
| Service Dogs | Number of Veterans Employed | Month 3 | 22 Participants |
| Service Dogs | Number of Veterans Employed | Month 12 | 21 Participants |
| Service Dogs | Number of Veterans Employed | Month 6 | 23 Participants |
p-value: 0.383Regression, Linear
Secondary
Patient Health Questionnaire (PHQ-9) Score
The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity).
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 6 | 10.55 score on a scale | Standard Deviation 6.03 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 12 | 11.03 score on a scale | Standard Deviation 6.31 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 3 | 11.46 score on a scale | Standard Deviation 6.05 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 15 | 11.47 score on a scale | Standard Deviation 6.2 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 9 | 11.53 score on a scale | Standard Deviation 6.18 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 18 | 9.43 score on a scale | Standard Deviation 6.24 |
| Emotional Support Dogs | Patient Health Questionnaire (PHQ-9) Score | Baseline | 13.08 score on a scale | Standard Deviation 5.94 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 18 | 8.19 score on a scale | Standard Deviation 4.45 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Baseline | 12.79 score on a scale | Standard Deviation 5.85 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 3 | 10.95 score on a scale | Standard Deviation 5.47 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 6 | 10.03 score on a scale | Standard Deviation 5.07 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 9 | 9.52 score on a scale | Standard Deviation 4.8 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 12 | 9.97 score on a scale | Standard Deviation 5.65 |
| Service Dogs | Patient Health Questionnaire (PHQ-9) Score | Month 15 | 9.67 score on a scale | Standard Deviation 5.79 |
p-value: 0.079Mixed Models Analysis
Secondary
Percentage of Days Covered for Antidepressants
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Percentage of Days Covered for Antidepressants | Baseline | 78.10 Percentage of days | Standard Deviation 21.6 |
| Emotional Support Dogs | Percentage of Days Covered for Antidepressants | Follow up | 70.50 Percentage of days | Standard Deviation 20.8 |
| Service Dogs | Percentage of Days Covered for Antidepressants | Baseline | 73.90 Percentage of days | Standard Deviation 23.2 |
| Service Dogs | Percentage of Days Covered for Antidepressants | Follow up | 77.20 Percentage of days | Standard Deviation 21.8 |
Secondary
Percentage of Days Covered for Antipsychotics
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Percentage of Days Covered for Antipsychotics | Baseline | 79.00 Percentage of days | Standard Deviation 22.4 |
| Emotional Support Dogs | Percentage of Days Covered for Antipsychotics | Follow up | 71.40 Percentage of days | Standard Deviation 28.5 |
| Service Dogs | Percentage of Days Covered for Antipsychotics | Baseline | 72.30 Percentage of days | Standard Deviation 20.9 |
| Service Dogs | Percentage of Days Covered for Antipsychotics | Follow up | 76.30 Percentage of days | Standard Deviation 17.4 |
Secondary
Percentage of Days Covered for Benzodiazepines
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Percentage of Days Covered for Benzodiazepines | Baseline | 61.60 Percentage of days | Standard Deviation 25.6 |
| Emotional Support Dogs | Percentage of Days Covered for Benzodiazepines | Follow up | 54.80 Percentage of days | Standard Deviation 28.3 |
| Service Dogs | Percentage of Days Covered for Benzodiazepines | Baseline | 72.60 Percentage of days | Standard Deviation 26.6 |
| Service Dogs | Percentage of Days Covered for Benzodiazepines | Follow up | 60.10 Percentage of days | Standard Deviation 29.3 |
Secondary
Percentage of Days Covered for Other Sedatives
The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage).
Time frame: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540
Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Percentage of Days Covered for Other Sedatives | Baseline | 66.90 Percentage of days | Standard Deviation 30.9 |
| Emotional Support Dogs | Percentage of Days Covered for Other Sedatives | Follow up | 79.10 Percentage of days | Standard Deviation 27.8 |
| Service Dogs | Percentage of Days Covered for Other Sedatives | Baseline | 63.20 Percentage of days | Standard Deviation 25.3 |
| Service Dogs | Percentage of Days Covered for Other Sedatives | Follow up | 63.00 Percentage of days | Standard Deviation 21.5 |
Secondary
Percentage of Participants With a Non-VA Hospitalization
Non-Veterans Administration (VA) healthcare utilization will be assessed using the HERC non-VA utilization survey. This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 6 | 5 Percentage of participants | Standard Deviation 23 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 12 | 3 Percentage of participants | Standard Deviation 17 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 3 | 3 Percentage of participants | Standard Deviation 16 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 15 | 0 Percentage of participants | Standard Deviation 0 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 9 | 3 Percentage of participants | Standard Deviation 17 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 18 | 0 Percentage of participants | Standard Deviation 0 |
| Emotional Support Dogs | Percentage of Participants With a Non-VA Hospitalization | Baseline | 0 Percentage of participants | Standard Deviation 0 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 18 | 2 Percentage of participants | Standard Deviation 15 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Baseline | 6 Percentage of participants | Standard Deviation 24 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 3 | 5 Percentage of participants | Standard Deviation 23 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 6 | 2 Percentage of participants | Standard Deviation 15 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 9 | 8 Percentage of participants | Standard Deviation 27 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 12 | 3 Percentage of participants | Standard Deviation 18 |
| Service Dogs | Percentage of Participants With a Non-VA Hospitalization | Month 15 | 1 Percentage of participants | Standard Deviation 11 |
p-value: 0.39Regression, Linear
Secondary
Pittsburgh Sleep Quality Index (PSQI) Global Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 6 | 13.10 score on a scale | Standard Deviation 4.6 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 12 | 13.24 score on a scale | Standard Deviation 4.88 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 3 | 13.60 score on a scale | Standard Deviation 4.79 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 15 | 12.91 score on a scale | Standard Deviation 4.64 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 9 | 13.29 score on a scale | Standard Deviation 4.59 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 18 | 12.54 score on a scale | Standard Deviation 4.85 |
| Emotional Support Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline | 14.26 score on a scale | Standard Deviation 4.09 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 18 | 11.74 score on a scale | Standard Deviation 4.33 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline | 13.60 score on a scale | Standard Deviation 3.85 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 3 | 12.51 score on a scale | Standard Deviation 4.24 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 6 | 12.17 score on a scale | Standard Deviation 4.13 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 9 | 12.36 score on a scale | Standard Deviation 4.37 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 12 | 12.27 score on a scale | Standard Deviation 4.34 |
| Service Dogs | Pittsburgh Sleep Quality Index (PSQI) Global Score | Month 15 | 12.02 score on a scale | Standard Deviation 4.5 |
p-value: 0.21Mixed Models Analysis
Secondary
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score
The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity.
Time frame: Baseline and every 3 months after dog pairing up to 18 months post-pairing
Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 6 | 39.66 score on a scale | Standard Deviation 16.43 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 12 | 40.01 score on a scale | Standard Deviation 17.6 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 3 | 41.96 score on a scale | Standard Deviation 15.45 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 15 | 41.23 score on a scale | Standard Deviation 16.5 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 9 | 41.04 score on a scale | Standard Deviation 15.49 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 18 | 35.25 score on a scale | Standard Deviation 17 |
| Emotional Support Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Baseline | 46.98 score on a scale | Standard Deviation 14.7 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 18 | 31.66 score on a scale | Standard Deviation 14.61 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Baseline | 48.33 score on a scale | Standard Deviation 15.66 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 3 | 41.54 score on a scale | Standard Deviation 15.14 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 6 | 39.39 score on a scale | Standard Deviation 14.87 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 9 | 38.29 score on a scale | Standard Deviation 15.04 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 12 | 35.48 score on a scale | Standard Deviation 15.39 |
| Service Dogs | Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score | Month 15 | 35.75 score on a scale | Standard Deviation 16.18 |
p-value: 0.036Mixed Models Analysis
Secondary
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 803.92 U.S. dollars | Standard Deviation 5758.11 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 70.04 U.S. dollars | Standard Deviation 456.89 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 132.36 U.S. dollars | Standard Deviation 1220.31 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 916.85 U.S. dollars | Standard Deviation 5527.54 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 1182.46 U.S. dollars | Standard Deviation 8807.28 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days (451-540) | 439.40 U.S. dollars | Standard Deviation 2943.53 |
| Emotional Support Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 184.53 U.S. dollars | Standard Deviation 1701.29 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days (451-540) | 333.03 U.S. dollars | Standard Deviation 2311.15 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 1341.99 U.S. dollars | Standard Deviation 7621.15 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 727.11 U.S. dollars | Standard Deviation 3513.19 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 567.10 U.S. dollars | Standard Deviation 3690.03 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 1219.27 U.S. dollars | Standard Deviation 8693.99 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 1403.54 U.S. dollars | Standard Deviation 6648.71 |
| Service Dogs | Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 1174.82 U.S. dollars | Standard Deviation 6770.73 |
Secondary
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers
Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 3684.87 U.S. dollars | Standard Deviation 3295.5 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 3494.07 U.S. dollars | Standard Deviation 3840.25 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 3997.82 U.S. dollars | Standard Deviation 3433.71 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 3762.58 U.S. dollars | Standard Deviation 3886.48 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 3869.49 U.S. dollars | Standard Deviation 4358.85 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 451-540 | 3685.47 U.S. dollars | Standard Deviation 4648.3 |
| Emotional Support Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 4701.32 U.S. dollars | Standard Deviation 4714.98 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 451-540 | 3449.97 U.S. dollars | Standard Deviation 4099.49 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Baseline (90 days prior to pairing) | 4496.76 U.S. dollars | Standard Deviation 4547.64 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 1-90 | 4696.70 U.S. dollars | Standard Deviation 4363.93 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 91-180 | 4579.89 U.S. dollars | Standard Deviation 4833.31 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 181-270 | 4360.64 U.S. dollars | Standard Deviation 4602.07 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 271-360 | 4025.24 U.S. dollars | Standard Deviation 4438.57 |
| Service Dogs | Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers | Days 361-450 | 4043.37 U.S. dollars | Standard Deviation 4333.64 |
Secondary
Total Cost of VA Healthcare (Inpatient and Outpatient)
Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.
Time frame: 540 days starting on the pairing date; summarized into six 90-day periods
Population: Participants randomized and paired with an emotional support dog or a service dog
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 91-180 | 4488.79 U.S. dollars | Standard Deviation 7642.83 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 271-360 | 3564.11 U.S. dollars | Standard Deviation 3895.45 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 1-90 | 4130.18 U.S. dollars | Standard Deviation 3637.66 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 361-450 | 4679.42 U.S. dollars | Standard Deviation 7081.99 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 181-270 | 5051.95 U.S. dollars | Standard Deviation 10019.56 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 451-540 | 4124.87 U.S. dollars | Standard Deviation 6196.64 |
| Emotional Support Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Baseline (90 days prior to pairing) | 4885.85 U.S. dollars | Standard Deviation 5043.26 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 451-540 | 3782.99 U.S. dollars | Standard Deviation 4929.9 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Baseline (90 days prior to pairing) | 5838.74 U.S. dollars | Standard Deviation 9613.11 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 1-90 | 5423.80 U.S. dollars | Standard Deviation 6612.74 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 91-180 | 5146.99 U.S. dollars | Standard Deviation 7084.47 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 181-270 | 5579.91 U.S. dollars | Standard Deviation 9864.29 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 271-360 | 5428.78 U.S. dollars | Standard Deviation 8514.41 |
| Service Dogs | Total Cost of VA Healthcare (Inpatient and Outpatient) | Days 361-450 | 5218.19 U.S. dollars | Standard Deviation 8398.77 |