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

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ClinicalTrials.gov Identifier: NCT03504722
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Charleston Research Institute

Brief 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).

Condition or disease Intervention/treatment Phase
PTSD Behavioral: RESCUE Behavioral: Prolonged Exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Feasibility of Recovery Through Engagement With Shelter Canines, Understanding, and Exposure (RESCUE): An Adjunctive Human Animal Interaction (HAI)-Based Intervention for Veterans With PTSD
Actual Study Start Date : September 27, 2016
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Experimental: RESCUE+PE
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.
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.
Other Name: PE

Active Comparator: PE+delayed RESCUE
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.
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.
Other Name: PE




Primary Outcome Measures :
  1. Change in Emotional Numbing Symptoms of PTSD [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    Clinician Administered PTSD Scale (CAPS) clinical interview - Emotional Numbing Item

  2. Change in Emotional Numbing Symptoms of PTSD [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    Posttraumatic Stress Disorder Checklist (PCL) self-report questionnaire -


Secondary Outcome Measures :
  1. Change in Treatment Engagement [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    Number of therapy sessions attended

  2. Change in PTSD diagnosis - interview [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    No longer meeting diagnostic criteria for PTSD via the Clinician Administered PTSD scale (CAPS) clinical interview

  3. Change in PTSD diagnosis - self-report [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    No longer meeting diagnostic criteria for PTSD via self-report PTSD symptoms on the PTSD Checklist (PCL)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Veterans with a principal Diagnostic and Statistical Manual-5th edition (DSM-5) PTSD diagnosis (via CAPS) stemming from a Criterion A event.
  2. Men or women aged 18 to 64 inclusive.
  3. Given that individuals with PTSD often have comorbid psychiatric disorders, participants with comorbid depressive, anxiety, substance use disorders, and personality disorders other than Antisocial Personality Disorder will be included as long as PTSD is the primary disorder
  4. Individuals with the ability to comprehend and satisfactorily comply with protocol requirements and who sign the written informed consent given prior to entering any study procedure

Exclusion Criteria:

  1. Individuals with active substance use disorders that require medical detoxification will be initially excluded from participation, but will be eligible once they have completed their detoxification.
  2. Veterans with comorbid Antisocial Personality Disorder, or history of animal cruelty will be excluded. Veterans with comorbid disorders that fall into the following DSM-5 categories will also be excluded: delirium, dementia, amnestic disorders, other cognitive disorders and psychotic disorders. Veterans with active Bipolar I or II and are not on a stable medication regime will be excluded.
  3. Given evidence suggesting that benzodiazepine medications restrict the therapeutic benefits of PE, potential participants will be required to taper and cease use under supervision of their prescribing physician. Participants must be off benzodiazepines for at least two weeks prior to enrolling in the study. Patients using antidepressant medication for PTSD will be eligible for participation as long as they are on a stable regimen (i.e., consistent dose for at least two weeks prior to enrollment and throughout the study).
  4. For safety purposes, Veterans who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others, will be excluded.
  5. Patients who are unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
  6. Patients who report a dog phobia or are otherwise opposed to working with dogs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504722


Contacts
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Contact: Anouk Grubaugh, PhD 843-532-6672 grubaugh@musc.edu
Contact: Ursula S Myers, PhD 843-789-6315 ursula.myers@va.gov

Locations
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United States, South Carolina
Ralph H. Johnson VAMC Recruiting
Charleston, South Carolina, United States, 29401
Contact: Rutha Larue, PhD    843-789-6707    rutha.larue@va.gov   
Contact: Kelsie Page    843-577-5011 ext 5913    kelly@chsri.org   
Principal Investigator: Anouk Grubaugh, PhD         
Sponsors and Collaborators
Charleston Research Institute
Investigators
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Principal Investigator: Anouk Grubaugh, PhD Ralph H. Johnson VA Medical Center

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Responsible Party: Charleston Research Institute
ClinicalTrials.gov Identifier: NCT03504722     History of Changes
Other Study ID Numbers: W81XWH-15-1-0087
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No