Clinical trial NCT03485391: Peer Social Support During In Vivo Exposure for PTSD
Official title: Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorder
Traumatic Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Charleston Research Institute
First posted: 2018-04-02
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Participant 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).

Participant 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.

Peer Inclusion Criteria:

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.

Peer Exclusion Criteria:

1. Active psychosis or dementia at screening.
2. Suicidal ideation with clear intent.

Primary outcomes:
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: 36 weeks
Secondary outcomes:
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 13 weeks
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 24 weeks
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 36 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 13 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 24 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 36 weeks
measure: Combat Exposure Scale (CES)
timeFrame: Baseline
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Wendy Muzzy, MRA, MLIS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ralph H. Johnson VA Medical Center
name: Ron Acierno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.