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| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shelter Dog Adoption | Experimental | 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. |
|
| Wait-list, Then Adoption after 3 Months | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shelter Dog Adoption | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 3-month follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen L. Stern, MD BA | South Texas Health Care System, San Antonio, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization to 3-month Follow-up |
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| ||||||||||||||||||
| 3-month to 6-month (Final) Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up visit. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional distress - reasons given under Additional Description | Psychiatric disorders | Systematic Assessment | wished dog had more room to run, worried dog was at home alone, unhappy was assigned to wait-list, dog chewed up things, dog dug up yard, dog too energetic, dog smelled bad, dog growled (2), dog had medical problems (2) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Stern | South Texas Veterans Health Care System; University of Texas Health Science Center at San Antonio | 210-887-3754 | stephen.stern@va.gov; sterns@uthscsa.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| 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). | Baseline and 3-month follow-up |
| 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). | Baseline and 3-month follow-up |
| 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. | Baseline and 3-month follow-up visit |
| 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). | Baseline and 3-month follow-up |
| 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. | Baseline and 3-month follow-up |
| 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). | Baseline and 3-month follow-up |
| 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 | 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 |
| 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). | Baseline and 3-month follow-up |
| 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). | Baseline and 3-month Follow-up |
| 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) | Baseline and 3-month follow-up |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
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| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
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| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
|
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|
|
| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
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|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up visit |
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| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
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|
| 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. | Posted | Number | percent of participants | Baseline and 3-month follow-up |
|
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|
|
| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
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| 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 | Participants who had a dog for 3 months. | Posted | Count of Participants | Participants | No | 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 |
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| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
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| 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). | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month Follow-up |
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| 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) | Posted | Mean | Standard Error | units on a scale | Baseline and 3-month follow-up |
|
|
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|
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | 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. | 0 | 10 | 4 | 10 |
|
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