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Therapist-Assisted Self-Management Program for PTSD (EMPOWER Trial)

N/A
Waitlist Available
Led By Shannon M. Kehle-Forbes, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 month period from treatment initiation to 9 months later
Awards & highlights

Summary

This trial tests a program to help people with PTSD feel better and reduce the need for frequent mental health appointments.

Who is the study for?
This trial is for veterans who have finished therapy for PTSD and seen improvement. They must have completed a specific course of treatment, agree to the study's terms, not start other weekly psychotherapies soon, and be open to any treatment arm. Those with suicidal thoughts needing monitoring can't join.Check my eligibility
What is being tested?
The study tests EMPOWER—a self-management program assisting those who've completed PTSD therapy—against usual treatments. It aims to help maintain or improve symptom management, boost confidence in handling symptoms, and potentially reduce future mental health appointments.See study design
What are the potential side effects?
Since this is a psychological support program rather than a medication trial, side effects may include emotional discomfort or stress due to discussing traumatic experiences but are generally expected to be less severe than pharmaceutical interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 month period from treatment initiation to 9 months later
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 month period from treatment initiation to 9 months later for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD Checklist-5 (PCL-5)
Veterans' Affairs Mental Health Service Utilization
Other outcome measures
Brief Inventory of Psychosocial Functioning (BIPF)
Client Satisfaction Questionnaire - 8 (CSQ-8)
DSM-5 Cross-cutting symptom measure
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EMPOWERExperimental Treatment1 Intervention
The goals of EMPOWER are to increase patients' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in TFT through the continued application of TFT skills, and encourage engagement in meaningful life activities. The program includes a Veteran workbook and four planned therapist contacts over the twelve weeks following TFT completion. The intervention includes: self-monitoring of symptoms, continued practice of TFT skills, engagement in meaningful activities, goal setting, and therapist support.
Group II: Treatment As UsualActive Control1 Intervention
The comparison condition will be TAU following completion of TFT. In the spirit of TAU, providers will not be restricted in the type or intensity of services offered. Depending on local clinic policy or norms, providers randomized to TFT may provide post-TFT treatment themselves or Veterans may be referred to other providers and/or back to the clinician who referred the Veteran to TFT. If providers would have typically discharged Veterans following TFT, that is also allowable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EMPOWER
2022
N/A
~130

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD, such as Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), work by helping patients process traumatic memories and reduce symptoms. PE involves gradual exposure to trauma-related memories and situations to decrease fear and avoidance, while CPT focuses on reframing negative thoughts about the trauma. The Therapist-Assisted Self-Management Program supports ongoing symptom management and builds patient confidence in handling symptoms independently. These mechanisms are important for PTSD patients as they promote active participation in treatment and support long-term recovery.
Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD.Symptom exacerbations in trauma-focused treatments: Associations with treatment outcome and non-completion.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,889 Total Patients Enrolled
Shannon M. Kehle-Forbes, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
2 Previous Clinical Trials
268 Total Patients Enrolled

Media Library

EMPOWER Clinical Trial Eligibility Overview. Trial Name: NCT05797441 — N/A
Post-Traumatic Stress Disorder Research Study Groups: EMPOWER, Treatment As Usual
Post-Traumatic Stress Disorder Clinical Trial 2023: EMPOWER Highlights & Side Effects. Trial Name: NCT05797441 — N/A
EMPOWER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797441 — N/A
~60 spots leftby Mar 2026