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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

EMPOWER Trial 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.

EMPOWER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 month period from treatment initiation to 9 months later

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

EMPOWER 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,513 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this medical trial that patients can take advantage of?

"Unfortunately, this medical trial is not currently recruiting for participants. It was initiated on July 5th 2023 and has been inactive since March 21st of the same year. However, there are still 400 other trials actively looking for subjects to join their research study."

Answered by AI

How many distinct sites are actively managing this trial?

"The James A. Haley Veterans' Hospital in Tampa, FL, the Jesse Brown VA Medical Center in Chicago, IL and Edward Hines Jr. VA Hospital in Hines, MN are all hosting this clinical trial with an additional 8 other sites being utilized as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy

2023. "Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05797441.