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Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD

NCT03504722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-01-22

No results posted yet for this study

Summary

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).

Conditions

Interventions

BEHAVIORAL

RESCUE

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.

BEHAVIORAL

Prolonged Exposure

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.

Sponsors & Collaborators

  • Charleston Research Institute

    lead OTHER

Principal Investigators

  • Anouk Grubaugh, PhD · Ralph H. Johnson VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-27
Primary Completion
2019-08-31
Completion
2019-09-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504722 on ClinicalTrials.gov