Clinical trial NCT05797441: Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy
Official title: Empowering Veterans to Self-Manage PTSD Symptoms Following Completion of Trauma-Focused Therapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PTSD
Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorders
PTSD
Self-Management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients will be eligible to participate if they:

  1. complete a course of individually-delivered TFT with a study therapist at a participating site
  2. experience a clinically meaningful change in PTSD symptomology
  3. 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
  4. are willing to receive to either arm
  5. provide informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 12 weeks post treatment initiation
measure: Veterans' Affairs Mental Health Service Utilization
timeFrame: 9 month period from treatment initiation to 9 months later
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 24 weeks post treatment initiation
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 40 weeks post treatment initiation
Secondary outcomes:
Other outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 weeks post treatment initiation
measure: Client Satisfaction Questionnaire - 8 (CSQ-8)
timeFrame: 12 weeks post treatment initiation
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 12 weeks post treatment initiation
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: 12 weeks post treatment initiation
measure: Well-Being Inventory (WBI)
timeFrame: 12 weeks post treatment initiation
measure: DSM-5 Cross-cutting symptom measure
timeFrame: 12 weeks post treatment initiation
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 24 weeks post treatment initiation
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 24 weeks post treatment initiation
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: 24 weeks post treatment initiation
measure: Well-Being Inventory (WBI)
timeFrame: 24 weeks post treatment initiation
measure: DSM-5 Cross-cutting symptom measure
timeFrame: 24 weeks post treatment initiation
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 40 weeks post treatment initiation
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 40 weeks post treatment initiation
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: 40 weeks post treatment initiation
measure: Well-Being Inventory (WBI)
timeFrame: 40 weeks post treatment initiation
measure: DSM-5 Cross-cutting symptom measure
timeFrame: 40 weeks post treatment initiation
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
city: Columbia
country: United States
facility: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
state: South Carolina
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Shannon M. Kehle-Forbes, PhD
role: PRINCIPAL_INVESTIGATOR
References: