Post Traumatic Stress Disorder
Conditions
Keywords
service dogs, human-animal interaction
Brief summary
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).
Detailed description
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
Interventions
BEHAVIORALService Dog
A service dog trained to perform tasks that are specific to PTSD
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
University of Arizona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinician Administered PTSD Scale for DSM-V (CAPS-5) assessments will be completed via telephone by a trained CAPS-5 rater who will be masked to the intervention and treatment arm of each participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for veterans into the study will include: * Applied for and approved to receive a dog from K9s For Warriors * Military service on or after September 11, 2001 * Honorable discharge or current honorable service * Diagnosis of PTSD * No conviction of any crimes against animals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Severity and Symptoms Via Self-report | 3 months | Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome. |
| PTSD Severity and Symptoms Via Clinician Rating | 3 months | Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome. |
| Depression | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. |
| Anxiety | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Socio-emotional Experiences | 3 months | Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome. |
| Companionship | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome |
| Ability to Participate in Social Activities | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome. |
| Mental Health Quality of Life | 3 months | Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome. |
| Psychological Well-being | 3 months | Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome. |
| Life Satisfaction | 3 months | Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome. |
| Resilience | 3 months | Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome. |
| Anger | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. |
| Social Isolation | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Ideation | 3 months | Columbia Suicide Severity Rating Scale (CSSRS) |
| Sleep Quality | 3 months | Pittsburgh Sleep Quality Assessment (PSQI) |
| Sleep Disturbance | 3 months | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a |
| Sleep Actigraphy | 3 months | Actiwatch 2 (Philips Respironics) |
| Salivary Cortisol Awakening Response | 3 months | Passive drool method (Salimetrics) |
| Electrodermal Activity (Skin Conductance) | 3 months | Embrace wristband (Empatica, Inc.) |
| Work and Activity Participation | 3 months | Work Productivity and Activity Impairment Questionnaire (WPAIQ) |
Countries
United States
Participant flow
Recruitment details
Recruitment, eligibility screening, and enrollment occurred between July 2017 and December 2019. Veterans were recruited through the database of an accredited nonprofit service dog organization, K9s For Warriors.
Pre-assignment details
Of 200 participants recruited and screened, 170 met inclusion criteria and were enrolled and allocated.
Participants by arm
| Arm | Count |
|---|---|
| Service Dog Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD | 81 |
| Waitlist Control Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog. | 75 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded (did not receive allocated condition) | 10 | 4 |
| Overall Study | Lost to Follow-up | 5 | 8 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | Service Dog |
|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 8.5 | 37.6 years STANDARD_DEVIATION 8.3 | 37.0 years STANDARD_DEVIATION 8.2 |
| Anxiety (PROMIS Anxiety) | 66.5 T-score STANDARD_DEVIATION 5.5 | 67.4 T-score STANDARD_DEVIATION 5.7 | 68.2 T-score STANDARD_DEVIATION 5.8 |
| BSPW | -2.2 units on a scale STANDARD_DEVIATION 1.9 | -2.4 units on a scale STANDARD_DEVIATION 1.8 | -2.7 units on a scale STANDARD_DEVIATION 1.8 |
| CD-RISC-10 | 20.8 units on a scale STANDARD_DEVIATION 7.2 | 19.1 units on a scale STANDARD_DEVIATION 7.5 | 17.5 units on a scale STANDARD_DEVIATION 7.5 |
| Depression (PROMIS Depression) | 62.7 T-score STANDARD_DEVIATION 8.4 | 63.8 T-score STANDARD_DEVIATION 8.1 | 64.9 T-score STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 121 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| PROMIS Anger | 64.9 T-score STANDARD_DEVIATION 8.7 | 66.9 T-score STANDARD_DEVIATION 9 | 68.7 T-score STANDARD_DEVIATION 9.1 |
| PROMIS Companionship | 46.9 T-score STANDARD_DEVIATION 9.5 | 45.9 T-score STANDARD_DEVIATION 10.1 | 44.9 T-score STANDARD_DEVIATION 10.7 |
| PROMIS Social Activities | 50.1 T-score STANDARD_DEVIATION 6.3 | 50.5 T-score STANDARD_DEVIATION 7.3 | 50.8 T-score STANDARD_DEVIATION 8.2 |
| PROMIS Social Isolation | 62.7 T-score STANDARD_DEVIATION 8.8 | 64.1 T-score STANDARD_DEVIATION 8.6 | 65.3 T-score STANDARD_DEVIATION 8.2 |
| PTSD (CAPS-5) | 40.0 units on a scale STANDARD_DEVIATION 7 | 41.1 units on a scale STANDARD_DEVIATION 7.4 | 42.0 units on a scale STANDARD_DEVIATION 7.6 |
| PTSD (PCL-5) | 55.7 units on a scale STANDARD_DEVIATION 14.3 | 56.4 units on a scale STANDARD_DEVIATION 12.8 | 57.0 units on a scale STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 55 Participants | 117 Participants | 62 Participants |
| Region of Enrollment United States | 75 participants | 156 participants | 81 participants |
| Sex: Female, Male Female | 22 Participants | 39 Participants | 17 Participants |
| Sex: Female, Male Male | 53 Participants | 117 Participants | 64 Participants |
| SWLS | 13.8 units on a scale STANDARD_DEVIATION 6.6 | 13.6 units on a scale STANDARD_DEVIATION 6.4 | 13.3 units on a scale STANDARD_DEVIATION 6.3 |
| VR-12 MCS | 28.2 units on a scale STANDARD_DEVIATION 9.9 | 27.1 units on a scale STANDARD_DEVIATION 10.7 | 26.0 units on a scale STANDARD_DEVIATION 11.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 75 |
| other Total, other adverse events | 1 / 81 | 0 / 75 |
| serious Total, serious adverse events | 4 / 81 | 6 / 75 |
Outcome results
Primary
Anxiety
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Anxiety | 62.1 T-score | Standard Deviation 7.1 |
| Waitlist Control | Anxiety | 66.0 T-score | Standard Deviation 5.4 |
p-value: <0.00195% CI: [0.13, 0.5]Ordinal cumulative probability model
Primary
Depression
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Depression | 58.9 T-score | Standard Deviation 9.5 |
| Waitlist Control | Depression | 61.4 T-score | Standard Deviation 8 |
p-value: 0.0295% CI: [0.23, 0.86]Ordinal cumulative probability model
Primary
PTSD Severity and Symptoms Via Clinician Rating
Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | PTSD Severity and Symptoms Via Clinician Rating | 30.2 units on a scale | Standard Deviation 10.2 |
| Waitlist Control | PTSD Severity and Symptoms Via Clinician Rating | 36.9 units on a scale | Standard Deviation 10.2 |
p-value: <0.00195% CI: [0.11, 0.4]Ordinal cumulative probability model
Primary
PTSD Severity and Symptoms Via Self-report
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | PTSD Severity and Symptoms Via Self-report | 41.9 units on a scale | Standard Deviation 16.9 |
| Waitlist Control | PTSD Severity and Symptoms Via Self-report | 51.7 units on a scale | Standard Deviation 16.1 |
p-value: <0.00195% CI: [0.12, 0.42]Ordinal cumulative probability model
Secondary
Ability to Participate in Social Activities
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Ability to Participate in Social Activities | 45.2 T-score | Standard Deviation 8.3 |
| Waitlist Control | Ability to Participate in Social Activities | 49.6 T-score | Standard Deviation 6.3 |
p-value: <0.00195% CI: [0.12, 0.48]Ordinal cumulative probability model
Secondary
Anger
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Anger | 61.2 T-score | Standard Deviation 10.5 |
| Waitlist Control | Anger | 64.1 T-score | Standard Deviation 10 |
p-value: 0.00995% CI: [0.2, 0.75]Ordinal cumulative probability model
Secondary
Companionship
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Companionship | 48.5 T-score | Standard Deviation 10.1 |
| Waitlist Control | Companionship | 45.2 T-score | Standard Deviation 9.3 |
p-value: 0.00395% CI: [1.47, 5.45]Ordinal cumulative probability model
Secondary
Daily Socio-emotional Experiences
Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome.
Time frame: 3 months
Population: This analysis was conducted with all participants who had available data based on initial group assignment. It differs from the other analyses in that it was done prior to the primary outcomes analysis and does not follow the same modified intent-to-treat analysis as conducted with the other outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Daily Socio-emotional Experiences | 4.2 units on a scale | Standard Deviation 1.5 |
| Waitlist Control | Daily Socio-emotional Experiences | 3.9 units on a scale | Standard Deviation 1.5 |
p-value: 0.002Mixed Models Analysis
Secondary
Life Satisfaction
Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Life Satisfaction | 19.7 units on a scale | Standard Deviation 7 |
| Waitlist Control | Life Satisfaction | 15.3 units on a scale | Standard Deviation 6.9 |
p-value: <0.00195% CI: [1.88, 7.4]Ordinal cumulative probability model
Secondary
Mental Health Quality of Life
Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Mental Health Quality of Life | 36.3 units on a scale | Standard Deviation 10.7 |
| Waitlist Control | Mental Health Quality of Life | 29.1 units on a scale | Standard Deviation 10.4 |
p-value: <0.00195% CI: [2, 7.38]Ordinal cumulative probability model
Secondary
Psychological Well-being
Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Psychological Well-being | -0.6 units on a scale | Standard Deviation 2.7 |
| Waitlist Control | Psychological Well-being | -2.2 units on a scale | Standard Deviation 2.2 |
p-value: <0.00195% CI: [2.28, 8.83]Ordinal cumulative probability model
Secondary
Resilience
Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Resilience | 21.7 units on a scale | Standard Deviation 6.3 |
| Waitlist Control | Resilience | 20.8 units on a scale | Standard Deviation 7.7 |
p-value: 0.0295% CI: [1.22, 4.47]Ordinal cumulative probability model
Secondary
Social Isolation
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Service Dog | Social Isolation | 60.1 T-score | Standard Deviation 10.8 |
| Waitlist Control | Social Isolation | 62.8 T-score | Standard Deviation 8.6 |
p-value: 0.00195% CI: [0.18, 0.64]Ordinal cumulative probability model
Other Pre-specified
Electrodermal Activity (Skin Conductance)
Embrace wristband (Empatica, Inc.)
Time frame: 3 months
Other Pre-specified
Salivary Cortisol Awakening Response
Passive drool method (Salimetrics)
Time frame: 3 months
Other Pre-specified
Sleep Actigraphy
Actiwatch 2 (Philips Respironics)
Time frame: 3 months
Other Pre-specified
Sleep Disturbance
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a
Time frame: 3 months
Other Pre-specified
Sleep Quality
Pittsburgh Sleep Quality Assessment (PSQI)
Time frame: 3 months
Other Pre-specified
Suicidal Ideation
Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: 3 months
Other Pre-specified
Work and Activity Participation
Work Productivity and Activity Impairment Questionnaire (WPAIQ)
Time frame: 3 months