A Self-Management Program for Completers of Trauma-Focused Therapy for PTSD

NCT03225859 | Completed Results

• 2 other identifiers: D2525-P1I21RX002525-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

Stress Disorders, Posttraumatic; Self-Management

Outcome Measures

Primary Outcomes (2)

• Credibility-Expectancy Scale (Credibility Subscale)

  Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).

  Prior to first self-management session (baseline)

• Client Satisfaction Scale

  Measures client satisfaction with mental health services (range = 8-32; higher scores = higher satisfaction)

  Three months after first self-management session (follow-up)

Secondary Outcomes (7)

• Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale)

  Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

• Change From Baseline on PTSD Checklist - 5

  Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

• Change From Baseline on Patient Health Questionnaire - 9

  Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

• Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale)

  Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

• Change From Baseline on World Health Organization Quality of Life - BREF

  Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Study Arms (1)

Self-Management Program

EXPERIMENTAL

Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.

Behavioral: Self-Management Program

Interventions

Self-Management Program BEHAVIORAL

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

Self-Management Program

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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Boston Healthcare System: collaborator
• Syracuse VA Medical Center: collaborator

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Shannon Kehle-Forbes, PhD
• Organization: Minneapolis VA Medical Center

Shannon.Kehle-Forbes@va.gov

612-467-4772

Study Officials

• Shannon M. Kehle-Forbes, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As everyone in the study will receive the same intervention, no masking is being employed
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study non-randomized, open-trial pilot test of the intervention with twelve Veterans who will all receive the study intervention.

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: November 5, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 28, 2020
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)