Peer Social Support During In Vivo Exposure for PTSD

NCT03485391 | Completed Results

• 2 other identifiers: Pro00075914W81XWH-18-1-0081
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical Administrated PTSD Scale (CAPS)

  The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Scores range from 0 to 80, with higher scores indicating worse outcomes.

  36 weeks

Secondary Outcomes (7)

• PTSD Checklist, 5th Version (PCL-5)

  13 weeks

• PTSD Checklist, 5th Version (PCL-5)

  24 weeks

• PTSD Checklist, 5th Version (PCL-5)

  36 weeks

• Patient Health Questionnaire (PHQ-9)

  13 weeks

• Patient Health Questionnaire (PHQ-9)

  24 weeks

Study Arms (2)

PE+Exposure Workout Buddy

EXPERIMENTAL

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.

Behavioral: Prolonged Exposure

PE+Peer General Support

ACTIVE COMPARATOR

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.

Behavioral: Prolonged Exposure

Interventions

Prolonged Exposure 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+Exposure Workout Buddy; PE+Peer General Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active psychosis or dementia at screening.
• Suicidal ideation with clear intent.
• Concurrent enrollment in another clinical trial for PTSD or depression.
• Adult male or female over the age of 18 that has served, or is currently serving, in the military.
• Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program.
• PCL-5 score of 32 or lower.
• Active psychosis or dementia at screening.
• Suicidal ideation with clear intent.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Charleston Research Institute: collaborator

Study Sites (1)

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• 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.

  PMID: 32345329 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Mental Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Stephanie Hart
• Organization: Ralph H. Johnson VA Health Care System

Stephanie.Hart4@va.gov

843-577-5011

Study Officials

• Wendy Muzzy, MRA, MLIS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Ron Acierno, PhD

  Ralph H. Johnson VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 2, 2018
• Study Start: May 1, 2018
• Primary Completion: March 3, 2023
• Study Completion: May 31, 2023
• Last Updated: August 16, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-08

Locations

US (1)