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To develop and pilot test feasibility, acceptability, and efficacy of an adjunct intervention for use with Empirically Based Treatments (EBT) for posttraumatic stress disorder (PTSD) in order to increase treatment engagement, treatment completion, and improve treatment response regarding emotional numbing symptoms. Recovery through Engagement with Shelter Canines, Understanding, and Exposure (RESCUE), is an adjunctive, Human Animal Interaction (HAI) intervention that will be developed for integration into Prolonged Exposure (PE) treatment. Feasibility, acceptability, and initial efficacy testing of the experimental treatment condition will be conducted in a pilot crossover randomized controlled trial (RCT) conducted with 75 veterans with PTSD randomly assigned to RESCUE delivered with PE (RESCUE+PE) or to standard PE initiation (PE + delayed RESCUE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESCUE+PE | Experimental | RESCUE is designed to adapt to individualized needs based on each veteran's performance. The volunteer training consists of weekly sessions lasting 90 minutes each and occurring at area Society for the Prevention of Cruelty to Animals (SPCA) facilities.All veterans will receive individualized, evidence-based prolonged exposure therapy. Foa's PE protocol will be used given consensus statements indicating that exposure therapy is currently the most appropriate psychotherapy for PTSD. |
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| PE+delayed RESCUE | Active Comparator | All veterans will receive individualized, evidence-based prolonged exposure therapy. Foa's PE protocol will be used given consensus statements indicating that exposure therapy is currently the most appropriate psychotherapy for PTSD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESCUE | Behavioral | RESCUE is designed to adapt to individualized needs based on each veteran's performance. The volunteer training consists of weekly sessions lasting 90 minutes each and occurring at area SPCA facilities. The logistics of the training sessions will be facilitated by study staff, with SPCA animal behaviorists and professionals conducting the training program identical to the program that they use for their general volunteer training. During volunteer sessions, the veteran learns behavioral techniques for training non-aggressive dogs through didactic instruction followed by demonstration and supervised practice. The animal socialization component of the RESCUE volunteer sessions are comprised of the SPCAs current training program, which is designed developmentally such that early training focuses on general topics (safety, basic handling skills) and later training builds on previously learned skills through successive approximation within each individual's zone of proximal development. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Numbing Symptoms of PTSD | Clinician Administered PTSD Scale (CAPS) clinical interview - Emotional Numbing Item | Through therapy completion (an average of 12 weeks) |
| Change in Emotional Numbing Symptoms of PTSD | Posttraumatic Stress Disorder Checklist (PCL) self-report questionnaire - | Through therapy completion (an average of 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment Engagement | Number of therapy sessions attended | Through therapy completion (an average of 12 weeks) |
| Change in PTSD diagnosis - interview | No longer meeting diagnostic criteria for PTSD via the Clinician Administered PTSD scale (CAPS) clinical interview |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anouk Grubaugh, PhD | Ralph H. Johnson VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VAMC | Charleston | South Carolina | 29401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31881993 | Derived | Grubaugh AL, Myers US, Keller SM, Wangelin BC, Lozano BE, Tuerk PW. An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):786. doi: 10.1186/s13063-019-3877-3. |
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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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| Prolonged Exposure | Behavioral | All veterans will receive individualized, evidence-based prolonged exposure therapy. Foa's PE protocol will be used given consensus statements indicating that exposure therapy is currently the most appropriate psychotherapy for PTSD. Study therapists are already trained clinicians through the VA's PE certification process and will receive weekly supervision for all cases from the PI, who is a national Prolonged Exposure trainer. |
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| Through therapy completion (an average of 12 weeks) |
| Change in PTSD diagnosis - self-report | No longer meeting diagnostic criteria for PTSD via self-report PTSD symptoms on the PTSD Checklist (PCL) | Through therapy completion (an average of 12 weeks) |