- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225859
A Self-Management Program for Completers of Trauma-Focused Therapy for PTSD (EMPOwER)
Pilot Test of a Self-Management Program for Completers of Trauma-Focused Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Impact: Findings from this project will improve the mental health and well-being of Veterans with posttraumatic stress disorder (PTSD) by refining and evaluating the first post-trauma focused therapy (TFT) intervention designed to help Veterans increase self-efficacy for managing their PTSD symptoms, maintain or build upon gains made in TFT, and increase community engagement. The current VA / Department of Defense PTSD clinical practice guidelines recommend decreasing the frequency and intensity of care (e.g. stepping-down) following successful TFT completion; this project is the initial step in developing the first evidence-based intervention for this important process. The project will advance RR&D's missions of evaluating interventions designed to maximize psychological recovery and prioritizing functional outcomes and societal engagement. Finally, the project will advance the scientific literature by being the first examination of a self-management intervention designed to be used to step down from an intensive course of therapy for PTSD.
Background: TFTs reduce the suffering associated with PTSD; a majority of Veterans who complete prolonged exposure or cognitive processing therapy report improvements in PTSD symptomology, quality of life, and functioning. Despite their effectiveness, emerging data suggest that Veterans who complete TFTs continue to perceive a need for mental health treatment; the investigators' pilot data demonstrated that the primary post-TFT mental health treatment need among completers who experienced at least a partial improvement in PTSD symptoms is support for additional practice and reinforcement of skills learned in TFT. Veterans expressed low self-efficacy for maintaining or building upon their existing gains and believed continued contact with their TFT therapist would increase their likelihood of success. These treatment needs are particularly well-suited to a therapist-assisted self-management approach. Self-management protocols teach patients to be responsible for the day-to-day management of their symptoms, thereby emphasizing patients' roles in wellness. The existing literature on self-management interventions for PTSD has demonstrated that such approaches are acceptable, safe, and effective; however, they have exclusively been used as stand-alone treatments or as the first step up in a stepped-care model. Therefore, the investigators are proposing the first examination of a self-management intervention designed to be used to step down from an intensive course of TFT for PTSD.
Objectives: The objective of this study is to complete stages 1A and 1B of the Stage Model of Treatment Development for the self-management program for Veterans who have recently completed a course of TFT for PTSD. Specifically, the investigators will: (1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers, (2) Conduct a pilot open trial to assess the (a) acceptability of the self-management program components, structure, and materials and (b) feasibility of the self-management program (retention and intervention fidelity) and study approach (screening, recruitment, assessment process), and (3) Explore the effects of the program on Veterans' confidence in managing their PTSD (self-efficacy), functioning, quality of life, community engagement, and mental health symptoms.
Methods: To achieve Aim 1, the investigators will conduct semi-structured individual interviews with a sample of TFT providers (n = 10-12), during which participants will be asked to provide feedback on the planned components and structure of the self-management program. To achieve Aims 2 and 3, the investigators will enroll twelve Veterans in a non-randomized, open-trial pilot test of the intervention at the Minneapolis VA Healthcare Systems (VAHCS). Enrolled Veterans will complete survey batteries immediately post-TFT, and survey batteries and qualitative interviews two weeks after the final self-management program therapist contact. Findings from this project will strongly position us to apply for Merit funding to conduct a randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this innovative self-management program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be eligible to participate if they:
- completed a course of individually-delivered trauma-focused therapy (TFT) with a provider trained to deliver the self-management intervention at the Minneapolis VAMC
- experienced a clinically meaningful reduction in PTSD symptomology (PCL decrease of at least 10 points) from pre-TFT to the time of the enrollment
- at the time of enrollment are not planning to initiate another active course of psychotherapy for PTSD in the following three months
- are willing to participate in a self-management intervention, and
- can provide informed consent
Exclusion Criteria:
- Veterans will be excluded if they have suicidal or homicidal ideation that in the opinion of their TFT therapist needs to be the focus of treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Self-Management Program
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
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This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities.
Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion.
The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility-Expectancy Scale (Credibility Subscale)
Time Frame: Prior to first self-management session (baseline)
|
Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).
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Prior to first self-management session (baseline)
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Client Satisfaction Scale
Time Frame: Three months after first self-management session (follow-up)
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Measures client satisfaction with mental health services (range = 8-32; higher scores = higher satisfaction)
|
Three months after first self-management session (follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale)
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measures patients' self-efficacy for managing PTSD symptoms; range = 1-5 (higher scores = greater perceived control; change from pre- to post-intervention reported.
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on PTSD Checklist - 5
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
|
Measures DSM-5 PTSD symptoms; Range = 0-80; higher scores = more severe symptoms; change score from pre- to post-treatment reported
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on Patient Health Questionnaire - 9
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measures symptoms of depression; range = 0-27; higher scores = more severe symptoms; pre- to post-treatment change score reported
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale)
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measures patients' perceived mental health; range 1-5; lower scores = better perceived mental health
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on World Health Organization Quality of Life - BREF
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measures patients' current quality of life; higher score = better quality of life; range = 0-100.
Change score from pre- to post-treatment reported
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on Military to Civilian Questionnaire
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measures patients' community engagement; range: 0-4; higher scores = more difficulty; change score from pre- to post-intervention reported
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Change From Baseline on Brief Inventory of Psychosocial Functioning
Time Frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Measure of PTSD-related psychosocial functional impairment; higher scores = more severe; range = 0-49; change from pre- to post-treatment reported
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Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2525-P
- 1I21RX002525-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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