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

PTSD Clinical Trial

Official title: Empowering Veterans to Self-Manage PTSD Symptoms Following Completion of Trauma-Focused Therapy

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

Background. Nearly 90% of Veterans who complete trauma-focused therapy (TFT) for PTSD have remaining treatment needs. In the six-months following TFT, successful completers remain some of the highest utilizers of VA mental health services despite clinically meaningful symptom improvement. Prior work demonstrated that Veterans who benefitted from TFT's primary post-TFT treatment needs were the practice and application of skills learned during therapy, with the goal of maintaining or building upon treatment gains. Veterans expressed low self-efficacy for meeting these goals without the support of their therapists and feared stagnation or relapse without ongoing contact. As such, a therapist-assisted self-management program for TFT completers (EMPOWER) designed as a step down from active psychotherapy was developed and feasibility tested. The feasibility open trial demonstrated that EMPOWER is feasible and highly acceptable to patients. Further, findings suggest that the intervention was successful in helping Veterans maintain or enhance PTSD-related gains while reducing their mental health service utilization. These promising findings warrant a randomized evaluation.

Significance. Interventions that meet Veterans' post-TFT treatment needs are urgently needed. Mental health providers are delivering ongoing treatment to this high priority cohort of Veterans without evidence to guide their treatment plan. Further, higher than expected levels of post-TFT mental health care utilization threatens the continued implementation of these highly effective treatments. For all Veterans to have access to the most effective treatments for PTSD, interventions that prepare and enable successful TFT completers to step down from active therapy must evaluated and implemented.

Innovation. The proposed study is the first large-scale study of post-TFT care and the first to rigorously evaluate a self-management program to step-down from active to maintenance mental health services following a course of active psychotherapy.

Specific Aims: 1) Estimate posterior probability distributions of EMPOWER's effects and establish likely ranges for those effects as compared to post-TFT TAU for Veterans' MH service utilization and self-reported PTSD symptoms. The subsequent Hybrid RCT will be designed after assessing the likelihood of detecting an effect for EMPOWER across a range of sample sizes using Go/No Go and Overall Power methods. 2) Explore the impact of EMPOWER compared to post-TFT TAU on Veterans'(a) self-efficacy for managing PTSD symptoms, (b) satisfaction with post-TFT care, (c) well-being & functioning (d) depression, and (e) secondary utilization outcomes. 3) Conduct semi-structured interviews with Veterans and providers to contextualize quantitative findings and identify potential barriers, facilitators, and strategies to facilitate future implementation of EMPOWER.

Methodology: The study is a pragmatic randomized control trial (RCT) in which 36 PE and CPT providers will be randomized to support Veterans as they participate in the EMPOWER self-management program or facilitate TAU. Participants will be patients of the study providers who recently completed a course of PE/CPT during which they experienced clinically meaningful reductions in PTSD symptoms (n=90). Primary outcomes will be mental health service utilization (overall and with PE/CPT providers) and self-reported PTSD symptoms measured four times over a 9-month period. Qualitative interviews with providers (n=18) and Veterans (n=24) focused on providers' impressions of treatment effectiveness, implementation challenges/potential strategies, and Veterans' perception of treatment effectiveness. ;

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05797441
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 16, 2023
• Completion date: March 31, 2026