Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs

NCT03533608 | Completed Results

• 2 other identifiers: CDX 18-002CDA 15-251
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.

Conditions

PTSD

Keywords

PTSD; Prolonged Exposure; Group Therapy

Outcome Measures

Primary Outcomes (2)

• Change in PTSD Symptoms

  PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).

  Baseline, 6-week, and 2-months

• Change in Depression Symptoms

  Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).

  Baseline, 6 weeks, 2-months

Study Arms (1)

Group PE

EXPERIMENTAL

Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Behavioral: Group PE

Interventions

Group PE BEHAVIORAL

Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Group PE

Eligibility Criteria

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, 49037, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Rebecca Sripada
• Organization: Center for Clinical Managment Research

rebecca.sripada@va.gov

734-222-7432

Study Officials

• Rebecca Kaufman Sripada, PhD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 23, 2018
• Study Start: June 1, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 25, 2023
• Results First Posted: March 5, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)