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Peer Social Support During In Vivo Exposure for PTSD (PEP)

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

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

Treatments

Behavioral: Prolonged Exposure

Study type

Interventional

Funder types

Other

Identifiers

NCT03485391
Pro00075914
W81XWH-18-1-0081 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

109 participants in 2 patient groups

PE+Exposure Workout Buddy
Experimental group
Description:
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.
Treatment:
Behavioral: Prolonged Exposure
PE+Peer General Support
Active Comparator group
Description:
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.
Treatment:
Behavioral: Prolonged Exposure

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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