Therapist-Assisted Self-Management Program for PTSD

(EMPOWER Trial)

Not currently recruiting at 8 trial locations

Overseen By Shannon M Kehle-Forbes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicidal ideation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on assisting individuals with PTSD (posttraumatic stress disorder) who have already experienced improvement from certain therapies. It tests a new program called EMPOWER (Therapist-Assisted Self-Management Program for PTSD), designed to boost patients' confidence in managing their symptoms and maintaining their progress. Participants will use a workbook and attend several sessions with a therapist over 12 weeks. Those who completed a specific PTSD therapy and observed significant improvements might be well-suited for this trial. As an unphased trial, this study provides a unique opportunity for participants to further enhance their self-management skills and sustain their progress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the EMPOWER intervention is safe for PTSD patients?

Research shows that EMPOWER, a program designed to help manage PTSD symptoms, is generally easy to handle. Previous studies suggest it can reduce symptoms of PTSD, anxiety, and depression. These studies did not report any major negative side effects. Instead, participants often felt more emotionally resilient and better at managing their symptoms. The program includes therapist support and self-monitoring, focusing on building confidence and encouraging meaningful activities. These elements aim to help participants maintain their progress and manage their symptoms effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER program because it offers a fresh approach to managing PTSD by focusing on self-management and empowerment. Unlike many standard PTSD treatments, which often rely heavily on therapist-driven sessions, EMPOWER encourages patients to take an active role in their healing journey. It integrates self-monitoring of symptoms, continued practice of trauma-focused therapy (TFT) skills, and engagement in meaningful activities, all supported by a therapist through regular check-ins. This method aims to boost patients' confidence in managing their symptoms independently and helps them maintain the progress made during initial therapy sessions.

What evidence suggests that the EMPOWER intervention is effective for managing PTSD?

Research shows that the EMPOWER program, available to participants in this trial, helps reduce symptoms of PTSD, anxiety, and depression. It increases patients' confidence in managing their symptoms and encourages engagement in meaningful activities. Previous studies indicate that people using EMPOWER experience fewer PTSD symptoms and feel less regret about their decisions. The program includes a workbook and therapist support, helping patients continue using skills learned in earlier treatments. This approach aims to maintain or even enhance the symptom reductions achieved with traditional PTSD therapies. ^{1 3 4 6 7}

Who Is on the Research Team?

Shannon M. Kehle-Forbes, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide informed consent

I have finished a therapy course with a study therapist.

I am willing to be assigned to any treatment group in the study.

Exclusion Criteria

Report suicidal ideation that requires clinical monitoring at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the EMPOWER self-management program, which includes a Veteran workbook and four planned therapist contacts over twelve weeks following TFT completion.

12 weeks

4 planned therapist contacts

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured over a 9-month period.

9 months

Outcome Assessment

Assessment of various outcomes including PTSD symptom severity, mental health service utilization, and quality of life, measured 40 weeks post treatment initiation.

40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EMPOWER
• Treatment As Usual

Trial Overview 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.

How Is the Trial Designed?

Group I: EMPOWER Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In an 8-week trial involving 45 service members with PTSD, self-management cognitive behavior therapy (CBT) showed significant reductions in PTSD symptoms and depression compared to supportive counseling.

One-third of participants who completed the self-management CBT achieved high-end state functioning at 6 months, suggesting it could be an effective treatment option for those with limited access to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Litz, BT., Engel, CC., Bryant, RA., et al.[2019]

The TARGET model is a new approach designed to treat both posttraumatic stress disorder (PTSD) and substance use disorders simultaneously, focusing on trauma and emotion self-regulation.

The model is based on extensive research and clinical literature, providing a structured skill set for therapists to use in both individual and group therapy settings, which is illustrated through real-life case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Ford, JD., Russo, E.[2018]

A pilot study involving 18 veterans showed that the Seeking Safety treatment, a cognitive-behavioral approach for those with both substance use disorders and PTSD, led to significant symptom reduction after 14 months of clinician training.

The treatment was well-received by clinicians, indicating its acceptability in a VA setting, although there are challenges to making it a standard part of routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. Cook, JM., Walser, RD., Kane, V., et al.[2022]

An intensive outpatient program (IOP) for PTSD, offering Prolonged Exposure and Cognitive Processing Therapy three or more times a week, achieved a high completion rate of 87.3% among veterans, indicating strong acceptability.

The IOP demonstrated significant effectiveness, with a large effect size (d = 1.80) in reducing PTSD symptoms, suggesting it is a promising treatment option to enhance engagement and outcomes in PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. Yamokoski, C., Flores, H., Facemire, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617585/

Enhancing & Mobilizing the POtential for Wellness & ... The EMPOWER intervention targets symptoms of peritraumatic stress and anticipatory grief that may interfere with optimal decision-making on the ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3515-0

Enhancing & Mobilizing the POtential for Wellness ... - Trials The EMPOWER intervention targets symptoms of peritraumatic stress and anticipatory grief that may interfere with optimal decision-making on the ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03276559/Prot_SAP_001.pdf

Enhancing & Mobilizing the Potential for Wellness & ... Those who are randomized to. EMPOWER will have reduced symptoms of PTSD, prolonged grief disorder, anxiety, and depression, and less decisional regret and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110718/

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in ... The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392424006584

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in ... The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03276559

Study Details | NCT03276559 | Enhancing & Mobilizing the ... Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31288829/

study protocol for a randomized controlled trial EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based ...