Peer Social Support During In Vivo Exposure for PTSD

NCT ID: NCT03485391

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2023-05-31

Brief Summary

Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and offered the opportunity to return to treatment, this time with the assistance of an in vivo exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy location and offer support an encouragement while the patient remains in that location. As the PTSD treatment standards in Charleston and other VA sites across the country increasingly include telemedicine delivered care, both in person and telemedicine based exposure therapy recipients will be included. There will be no randomization; all participants will receive the peer support 'workout buddy' for exposure therapy assignments.

Detailed Description

Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center catchment area. Participants will have been assigned to exposure therapy for PTSD and either started treatment, or dropped out before treatment; peers will have successfully completed exposure therapy for PTSD. Those eligible to participate will also include Veterans who are identified as "at-risk" of dropping out, Veterans who are uncomfortable completing in vivo exposure activities, and those who may have PTSD symptoms, but at the sub-threshold level. Participants will receive 8-12 weekly sessions of exposure therapy treatment with assistance of a PE Peer. Half of subjects will be randomized to the PE+Workout Buddy condition, where they will complete treatment with the assistance of a Veteran who will meet them at least once per week for in vivo exposure therapy assignments, for 3-4 weeks at the beginning of treatment. Half of subjects will be randomized to the PE+General Support condition, where they will complete treatment with the assistance of a Veteran who will call them via telephone once per week to encourage session attendance and ask about treatment progress, life stresses, etc. General support peers will also meeting Veterans 2-4 times per month to check in about treatment progress. All participants and peers will be consented. Participants will be assessed at baseline, post-treatment, and 3- & 6-month follow-up.

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Mental Disorder; Traumatic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PE+Exposure Workout Buddy

Prolonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure.

Group Type: EXPERIMENTAL

Prolonged Exposure

Intervention Type: BEHAVIORAL

Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.

PE+Peer General Support

Prolonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress.

Group Type: ACTIVE_COMPARATOR

Prolonged Exposure

Intervention Type: BEHAVIORAL

Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.

Interventions

Prolonged Exposure

Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adult male or female over the age of 18 that has served, or is currently serving in the military.

2. Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25, and a PCL-5 score of ≥25.

3. Attempted PE treatment in the past, but did not complete treatment (defined as dropping out from treatment or refusal to engage in in vivo exposure assignments) OR identified as "at-risk" of dropping out of current exposure therapy treatment (defined as failure to complete 3 sessions of therapy within any 6 week period or verbally indicating that they are not comfortable with the exposure activities).

1. Adult male or female over the age of 18 that has served, or is currently serving, in the military.

2. Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program.

3. PCL-5 score of 32 or lower.

Exclusion Criteria

1. Active psychosis or dementia at screening.

2. Suicidal ideation with clear intent.

3. Concurrent enrollment in another clinical trial for PTSD or depression.

1. Active psychosis or dementia at screening.

2. Suicidal ideation with clear intent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charleston Research Institute

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Muzzy, MRA, MLIS

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Ron Acierno, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center

Locations

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

Countries

United States

References

Hernandez-Tejada MA, Muzzy W, Price M, Hamski S, Hart S, Foa E, Acierno R. Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial. Trials. 2020 Apr 28;21(1):366. doi: 10.1186/s13063-020-04302-5.

Reference Type: DERIVED

PMID: 32345329 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W81XWH-18-1-0081

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00075914

Identifier Type: -

Identifier Source: org_study_id