Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
Status: | Recruiting |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/1/2019 |
Start Date: | September 27, 2016 |
End Date: | September 1, 2019 |
Contact: | Anouk Grubaugh, PhD |
Email: | grubaugh@musc.edu |
Phone: | 843-532-6672 |
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
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).
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).
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.
We found this trial at
1
site
Charleston, South Carolina 29403
Principal Investigator: Anouk Grubaugh, PhD
Phone: 843-789-6707
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