PTSDRESCUENCT03504722
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
A study testing RESCUE and Prolonged Exposure in people with PTSD, run by Charleston Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- RESCUE and Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with a principal Diagnostic and Statistical Manual-5th edition (DSM-5) PTSD diagnosis (via CAPS) stemming from a Criterion A event.
- Men or women aged 18 to 64 inclusive.
- 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
- 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
Who cannot join
- 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.
- 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.
- 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).
- 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.
- 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.
- Patients who report a dog phobia or are otherwise opposed to working with dogs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
About this study
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
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
- PTSD
- Being tested
- RESCUE, Prolonged Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESCUEBehavioural
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.
Prolonged ExposureBehavioural
Also called PE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: RESCUE; Behavioral: Prolonged Exposure |
| 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. Receives: Behavioral: Prolonged Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Numbing Symptoms of PTSD
Clinician Administered PTSD Scale (CAPS) clinical interview - Emotional Numbing Item
Measured: Through therapy completion (an average of 12 weeks)
Change in Emotional Numbing Symptoms of PTSD
Posttraumatic Stress Disorder Checklist (PCL) self-report questionnaire -
Measured: Through therapy completion (an average of 12 weeks)
Secondary outcomes (3)
Change in Treatment Engagement
Number of therapy sessions attended
Measured: 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
Measured: 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)
Measured: Through therapy completion (an average of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start27 Sep 2016
- Primary completion31 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charleston Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anouk Grubaugh, PhD, Principal investigator, Ralph H. Johnson VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504722
- Sponsor's protocol ID
- W81XWH-15-1-0087
- Acronym
- RESCUE
- Status last verified
- Jan 2020
- First submitted
- 2 May 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31881993
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03504722
- Acronym / sponsor ID
- RESCUE / W81XWH-15-1-0087
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Charleston Research InstituteUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESCUE+PE | Experimental | Behavioral: RESCUE, Behavioral: Prolonged ExposureRESCUE 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. |
| PE+delayed RESCUE | Active comparator | Behavioral: Prolonged ExposureAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans with a principal Diagnostic and Statistical Manual-5th edition (DSM-5) PTSD diagnosis (via CAPS) stemming from a Criterion A event.
- Men or women aged 18 to 64 inclusive.
- 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
- 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
Key exclusion criteria (6 listed)
- 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.
- 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.
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESCUERESCUE 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. | Behavioural | RESCUE+PE |
| Prolonged ExposureAlso: PEAll 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. | Behavioural | PE+delayed RESCUE, RESCUE+PE |
Primary outcome
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 -
3 secondary outcomes
Change in Treatment Engagement
Time frame: Through therapy completion (an average of 12 weeks)
Change in PTSD diagnosis - interview
Time frame: Through therapy completion (an average of 12 weeks)
Change in PTSD diagnosis - self-report
Time frame: Through therapy completion (an average of 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 31881993Grubaugh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anouk Grubaugh, PhD principal investigator
Ralph H. Johnson VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESCUE and Prolonged Exposure in people with PTSD, run by Charleston Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Numbing Symptoms of PTSD (time frame: Through therapy completion (an average of 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03504722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.