Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504722
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Charleston Research Institute

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE September 27, 2016
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • 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
  • 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 -
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Change in Treatment Engagement [ Time Frame: Through therapy completion (an average of 12 weeks) ]
    Number of therapy sessions attended
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: RESCUE
    • Behavioral: Prolonged Exposure
  • 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.
    Intervention: Behavioral: Prolonged Exposure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2020)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
75
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504722
Other Study ID Numbers  ICMJE W81XWH-15-1-0087
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Charleston Research Institute
Study Sponsor  ICMJE Charleston Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anouk Grubaugh, PhD Ralph H. Johnson VA Medical Center
PRS Account Charleston Research Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP