South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229, United States
NCT Number: NCT01729026
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Early Phase 1
San Antonio, Texas, 78229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
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
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 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).
Time frame: 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).
Time frame: 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)
VA Office of Research and Development
Fed
A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
Acronym: VITAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07731906
Mental Disorders, Posttraumatic Stress Disorder (PTSD)
Salerno, Italy
View Trial DetailsNCT06685965
Dyssomnias, Mental Disorders
Zurich, Canton of Zurich, Switzerland
View Trial DetailsNCT07521020
Mental Disorders, Posttraumatic Stress Disorder (PTSD)
Ürümqi, Xinjiang, China
View Trial DetailsNCT06646692
Anxiety, Anxiety Disorders
Pomona, California, United States
View Trial Details