N/A
N=12
A Self-Management Program for Completers of Trauma-Focused Therapy for PTSD
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03225859 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Feb 2021
Primary outcome: Primary: Credibility-Expectancy Scale (Credibility Subscale) — 6.39 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-Management Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Credibility-Expectancy Scale (Credibility Subscale) |
6.39 | — |
| PRIMARY Client Satisfaction Scale |
29.67 | — |
| SECONDARY Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale) |
0.33 | — |
| SECONDARY Change From Baseline on PTSD Checklist - 5 |
-1.67 | — |
| SECONDARY Change From Baseline on Patient Health Questionnaire - 9 |
-0.14 | — |
| SECONDARY Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale) |
-1.0 | — |
| SECONDARY Change From Baseline on World Health Organization Quality of Life - BREF |
6.62 | — |
| SECONDARY Change From Baseline on Military to Civilian Questionnaire |
-0.27 | — |
| SECONDARY Change From Baseline on Brief Inventory of Psychosocial Functioning |
4.44 | — |
Summary
Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic stress disorder symptoms, quality of life, and social and role functioning. However, many also report uncertainty regarding their ability to maintain and build upon progress made during TFTs following the end of treatment. Veterans who recently completed a course of TFT believe the likelihood of their ongoing success would be bolstered by mental health services that support additional practice and reinforcement of skills learned in TFT. Currently no evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs are well-suited to a therapist-assisted self-management approach. The objective of this project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of Treatment Development for a post-TFT therapist-assisted self-management program designed to help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess the acceptability and feasibility of the self-management program, and 3) Explore the effects of the program on Veterans' confidence in managing their PTSD and Veterans' functioning, quality of life, community engagement, and mental health symptoms.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03225859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.