Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy

NCT05797441 | Completed DMC

• 1 other identifier: IIR 20-102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief Summary

Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.

Conditions

PTSD; Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorders; PTSD; Self-Management

Outcome Measures

Primary Outcomes (4)

• PTSD Checklist-5 (PCL-5)

  PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms

  12 weeks post treatment initiation

• Veterans' Affairs Mental Health Service Utilization

  All encounters with a mental health stop code in the Veterans Health Administration; variable is a count of total encounters

  9 month period from treatment initiation to 9 months later

• PTSD Checklist-5 (PCL-5)

  PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms

  24 weeks post treatment initiation

• PTSD Checklist-5 (PCL-5)

  PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms

  40 weeks post treatment initiation

Other Outcomes (16)

• Patient Health Questionnaire-9 (PHQ-9)

  12 weeks post treatment initiation

• Client Satisfaction Questionnaire - 8 (CSQ-8)

  12 weeks post treatment initiation

• Brief Inventory of Psychosocial Functioning (BIPF)

  12 weeks post treatment initiation

Study Arms (2)

EMPOWER

EXPERIMENTAL

The goals of EMPOWER are to increase patients' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in TFT through the continued application of TFT skills, and encourage engagement in meaningful life activities. The program includes a Veteran workbook and four planned therapist contacts over the twelve weeks following TFT completion. The intervention includes: self-monitoring of symptoms, continued practice of TFT skills, engagement in meaningful activities, goal setting, and therapist support.

Behavioral: EMPOWER

Treatment As Usual

ACTIVE COMPARATOR

The comparison condition will be TAU following completion of TFT. In the spirit of TAU, providers will not be restricted in the type or intensity of services offered. Depending on local clinic policy or norms, providers randomized to TFT may provide post-TFT treatment themselves or Veterans may be referred to other providers and/or back to the clinician who referred the Veteran to TFT. If providers would have typically discharged Veterans following TFT, that is also allowable.

Other: Treatment As Usual

Interventions

EMPOWER BEHAVIORAL

The goals of EMPOWER are to increase patients' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in TFT through the continued application of TFT skills, and encourage engagement in meaningful life activities. The program includes a Veteran workbook and four planned therapist contacts over the twelve weeks following TFT completion. The intervention includes: self-monitoring of symptoms, continued practice of TFT skills, engagement in meaningful activities, goal setting, and therapist support.

EMPOWER

Treatment As Usual OTHER

The comparison condition will be TAU following completion of TFT. In the spirit of TAU, providers will not be restricted in the type or intensity of services offered. Depending on local clinic policy or norms, providers randomized to TFT may provide post-TFT treatment themselves or Veterans may be referred to other providers and/or back to the clinician who referred the Veteran to TFT. If providers would have typically discharged Veterans following TFT, that is also allowable.

Treatment As Usual

Eligibility Criteria

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

You may qualify if:

• Patients will be eligible to participate if they:
• complete a course of individually-delivered TFT with a study therapist at a participating site
• experience a clinically meaningful change in PTSD symptomology
• at the time of enrollment (in either the TAU or EMPOWER arm), are not planning to initiate another weekly psychotherapy for PTSD for another mental or psychosocial condition within 3 months
• are willing to receive to either arm
• provide informed consent

You may not qualify if:

• Patients will be excluded if they report suicidal ideation that requires clinical monitoring at baseline

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (8)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213, United States

Location

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209-1638, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Shannon M. Kehle-Forbes, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Conducting a planning RCT in preparation for a fully powered trial using a parallel two-group pragmatic RCT design in which providers (n = 36) will be randomized at a 2:1 ratio to deliver either EMPOWER (n = 60) or TAU (n = 30) to veterans who have completed prolonged exposure or cognitive processing therapy.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: October 16, 2023
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)