NCT03225859: EMPOwER

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

Completed NA Results posted Last updated 8 February 2021

What this trial tests

NA trial testing Self-Management Program in Posttraumatic Stress Disorder in 12 participants. Completed in 28 February 2020.

Timeline

5 November 2018

Primary endpoint
17 February 2020

28 February 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	5 November 2018
Primary completion	17 February 2020
Estimated completion	28 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Self-Management Program

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Credibility-Expectancy Scale (Credibility Subscale) Primary · Prior to first self-management session (baseline)

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

Group	Value	95% CI
Self-Management Program	6.39	± 1.73

Client Satisfaction Scale Primary · Three months after first self-management session (follow-up)

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

Group	Value	95% CI
Self-Management Program	29.67	± 2.74

Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale) Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measures patients' self-efficacy for managing PTSD symptoms; range = 1-5 (higher scores = greater perceived control; change from pre- to post-intervention reported.

Group	Value	95% CI
Self-Management Program	0.33	± 1.66

Change From Baseline on PTSD Checklist - 5 Secondary · 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

Group	Value	95% CI
Self-Management Program	-1.67	± 8.26

Change From Baseline on Patient Health Questionnaire - 9 Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measures symptoms of depression; range = 0-27; higher scores = more severe symptoms; pre- to post-treatment change score reported

Group	Value	95% CI
Self-Management Program	-0.14	± 2.79

Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale) Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measures patients' perceived mental health; range 1-5; lower scores = better perceived mental health

Group	Value	95% CI
Self-Management Program	-1.0	± 0.64

Change From Baseline on World Health Organization Quality of Life - BREF Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measures patients' current quality of life; higher score = better quality of life; range = 0-100. Change score from pre- to post-treatment reported

Group	Value	95% CI
Self-Management Program	6.62	± 6.25

Change From Baseline on Military to Civilian Questionnaire Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measures patients' community engagement; range: 0-4; higher scores = more difficulty; change score from pre- to post-intervention reported

Group	Value	95% CI
Self-Management Program	-0.27	± 0.41

Change From Baseline on Brief Inventory of Psychosocial Functioning Secondary · Prior to first self-management session (baseline) and three months after first self-management session (follow-up)

Measure of PTSD-related psychosocial functional impairment; higher scores = more severe; range = 0-49; change from pre- to post-treatment reported

Group	Value	95% CI
Self-Management Program	4.44	± 14.02

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Self-Management Program

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (1 terms)

Reaction	System	Self-Management Program
Hospitalization	Cardiac disorders	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT03225859 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.