Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
Veterans, Posttraumatic Stress Disorder, dog adoption, companion animal
Brief summary
The purpose of this study is to provide preliminary data on the feasibility and impact of adopting a dog from an animal shelter as a supplement to usual care in Veterans with Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.
Detailed description
Posttraumatic Stress Disorder, a common mental disorder among Veterans, is marked by painful re-experiencing of a traumatic event, often together with depression, fearfulness, and social isolation. Despite major advances in rehabilitation, many Veterans continue to be disabled by PTSD. One possible new approach involves the use of shelter dogs, which might relieve symptoms and aid reintegration into society by providing emotional support and a greater sense of security. In this randomized controlled trial of 48 Veterans with chronic PTSD, we will evaluate whether the half who adopt a dog from the San Antonio Humane Society show greater improvement in their PTSD symptoms over the first three months than the half who are assigned to a waiting list.
Interventions
OTHERShelter Dog Adoption
Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Sponsors
The University of Texas Health Science Center at San Antonio
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS) * Scores 39 or greater on the PTSD Checklist for DSM-5 (PCL-5) * Feels able to afford to care for a dog after the anticipated annual costs of approximately $750 are outlined * If married or cohabiting, spouse or significant other agrees with the decision to adopt a dog * If not a homeowner, landlady or landlord agrees to allow the dog to reside on the property * Agrees to keep the dog inside most of the time * Agrees to be the primary caretaker for the dog * Had a dog previously as a child or adult * Served during the Vietnam era or more recently * In active therapy for at least 1 month, with plans to remain in active therapy * Has been in a stable housing situation for the last 3 months * Case manager for any Veteran who is in the Housing and Urban Development/VA Subsidized Housing (HUD/VASH) program has been consulted prior to study enrollment * Has a plan for someone else to take care of the dog if she or he can't
Exclusion criteria
* Has had a dog or other companion animal within the past 12 months * Has current alcohol or drug abuse or dependence * Has a primary psychiatric diagnosis other than PTSD * Has had significant suicide/homicide risk in the past 3 months * Has had psychosis or mania in the past 3 months * Has had a psychiatric admission during the past 3 months * Has mental or physical impairments that would interfere with caring for the dog or self * Has a history of moderate to severe traumatic brain injury (TBI) (subjects with moderate TBI will be allowed to participate in the study if a Physical Medicine and Rehabilitation physician determines it is acceptable) * Requires a puppy * Requires a breed that is uncommonly available for adoption at the San Antonio Humane Society * Requires a pit bull or other fierce dog * Veteran's mental health clinician or Physical Medicine and Rehabilitation physician reports a past history of animal cruelty or abuse or expresses concern about the potential for such behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up | Baseline and 3-month follow-up visit. | The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score | Baseline and 3-month follow-up | Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking). |
| Change in Beck Depression Inventory - II (BDI-II) Score | Baseline and 3-month follow-up | The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms). |
| Change in Community Integration Questionnaire (CIQ) Total Score | Baseline and 3-month follow-up visit | Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration. |
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | Baseline and 3-month follow-up | The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms). |
| Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ) | Baseline and 3-month follow-up | The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100. |
| Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) | Baseline and 3-month follow-up | The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms). |
| Number of Participants With Improvement in Quality of Life After Dog Adoption | Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls | Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog |
| Change in Scores on the UCLA Loneliness Scale, Version 3 | Baseline and 3-month follow-up | The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms). |
| Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12) | Baseline and 3-month Follow-up | The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health). |
| Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS) | Baseline and 3-month follow-up | The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain) |
| Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) | Baseline and 3-month follow-up | Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality). |
Countries
United States
Participant flow
Recruitment details
Enrollment opened in October 2013 and closed at the end of September 2014. Subjects learned about the study primarily from clinical staff or from posters and brochures that were distributed throughout the clinics of the South Texas Veterans Health Care System in San Antonio.
Pre-assignment details
Two of the 22 consented subjects were not randomized: one left before he was evaluated and the second did not meet entry criteria. A third subject was randomized to the Adoption group but subsequently found not to meet criteria for PTSD, leaving 9 in this group and 10 in the Wait-List group.
Participants by arm
| Arm | Count |
|---|---|
| Shelter Dog Adoption Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian. | 9 |
| Wait-list, Then Adoption After 3 Months After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian. | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-month to 6-month (Final) Follow-up | Lost to Follow-up | 1 | 2 |
| Randomization to 3-month Follow-up | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Shelter Dog Adoption | Wait-list, Then Adoption After 3 Months | Total |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 13.8 | 39.2 years STANDARD_DEVIATION 11.4 | 42.1 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 9 | 4 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
Time frame: Baseline and 3-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up | -15.20 units on a scale | Standard Error 3.52 |
| Wait-list, Then Adoption After 3 Months | Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up | -7.77 units on a scale | Standard Error 3.29 |
Comparison: The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.p-value: 0.14195% CI: [-1.85, 0.35]Mixed effects regression models
Secondary
Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score
Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score | -0.5 units on a scale | Standard Error 0.6 |
| Wait-list, Then Adoption After 3 Months | Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score | 0.7 units on a scale | Standard Error 0.6 |
p-value: 0.16effect size (Cohen's d)
Secondary
Change in Beck Depression Inventory - II (BDI-II) Score
The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Beck Depression Inventory - II (BDI-II) Score | -6.41 units on a scale | Standard Error 1.72 |
| Wait-list, Then Adoption After 3 Months | Change in Beck Depression Inventory - II (BDI-II) Score | -0.19 units on a scale | Standard Error 1.5 |
p-value: 0.01595% CI: [-2.49, -0.23]effect size (Cohen's d)
Secondary
Change in Community Integration Questionnaire (CIQ) Total Score
Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.
Time frame: Baseline and 3-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Community Integration Questionnaire (CIQ) Total Score | 2.9 units on a scale | Standard Error 1.1 |
| Wait-list, Then Adoption After 3 Months | Change in Community Integration Questionnaire (CIQ) Total Score | 2.1 units on a scale | Standard Error 1 |
p-value: 0.59Mixed Models Analysis
Secondary
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Patient Health Questionnaire-9 (PHQ-9) Score | -4.07 units on a scale | Standard Error 1.2 |
| Wait-list, Then Adoption After 3 Months | Change in Patient Health Questionnaire-9 (PHQ-9) Score | 0.71 units on a scale | Standard Error 1.13 |
p-value: 0.0195% CI: [-2.5, -0.31]effect size (Cohen's d)
Secondary
Change in Scores on the UCLA Loneliness Scale, Version 3
The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Scores on the UCLA Loneliness Scale, Version 3 | -7.8 units on a scale | Standard Error 3.5 |
| Wait-list, Then Adoption After 3 Months | Change in Scores on the UCLA Loneliness Scale, Version 3 | 3.4 units on a scale | Standard Error 3.3 |
p-value: 0.031mixed effects regression models
Secondary
Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) | -1.3 units on a scale | Standard Error 1.4 |
| Wait-list, Then Adoption After 3 Months | Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) | 1.3 units on a scale | Standard Error 1.2 |
p-value: 0.188effect size (Cohen's d)
Secondary
Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) | 1.4 units on a scale | Standard Error 3 |
| Wait-list, Then Adoption After 3 Months | Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) | 1.5 units on a scale | Standard Error 2.9 |
p-value: 0.982effect size (Cohen's d)
Secondary
Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)
The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS) | -0.1 units on a scale | Standard Error 0.7 |
| Wait-list, Then Adoption After 3 Months | Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS) | -1.6 units on a scale | Standard Error 0.7 |
Comparison: Please note that a minus number indicates an increase in pain ratings.p-value: 0.139effect size (Cohen's d)
Secondary
Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)
The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).
Time frame: Baseline and 3-month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shelter Dog Adoption | Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12) | 6.01 units on a scale | Standard Error 4.34 |
| Wait-list, Then Adoption After 3 Months | Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12) | 2.30 units on a scale | Standard Error 4.06 |
p-value: 0.54195% CI: [-0.8, 1.4]effect size (Cohen's d)
Secondary
Number of Participants With Improvement in Quality of Life After Dog Adoption
Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog
Time frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls
Population: Participants who had a dog for 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shelter Dog Adoption | Number of Participants With Improvement in Quality of Life After Dog Adoption | 5 Participants |
| Wait-list, Then Adoption After 3 Months | Number of Participants With Improvement in Quality of Life After Dog Adoption | 4 Participants |
Secondary
Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)
The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shelter Dog Adoption | Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ) | 40 percent of participants |
| Wait-list, Then Adoption After 3 Months | Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ) | 33 percent of participants |
p-value: 0.13Fisher Exact