Therapist-Assisted Self-Management Program for PTSD

(EMPOWER Trial)

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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program called EMPOWER that helps veterans who have completed PTSD therapy manage their own symptoms with some help from a therapist. It aims to maintain or improve their mental health and reduce the number of therapy sessions they need.

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 data supports the effectiveness of the treatment EMPOWER for PTSD?

Research shows that trauma-focused guided self-help, similar to the EMPOWER program, effectively reduces PTSD symptoms and related depression and anxiety. Additionally, strong alliances between survivors and advocates, as seen in domestic violence programs, can empower individuals and reduce PTSD symptoms. ^{1 2 3 4 5}

Is the Therapist-Assisted Self-Management Program for PTSD safe for humans?

Research on trauma-focused treatments for PTSD, like Prolonged Exposure and Cognitive Processing Therapy, shows they are generally safe, even though some people might experience temporary increases in symptoms. These treatments are effective and most people see improvement by the end of the treatment. ^{6 7 8 9 10}

What makes the EMPOWER treatment for PTSD unique?

The EMPOWER treatment is unique because it combines therapist assistance with a self-management program delivered over the Internet, making it more accessible and flexible compared to traditional face-to-face therapy sessions. ^{4 7 11 12 13}

Research Team

Shannon M. Kehle-Forbes, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The predictive value of trauma-related coping self-efficacy for posttraumatic stress symptoms: Differences between treatment-seeking and non-treatment-seeking victims. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Taking charge: a pilot curriculum of self-defense and personal safety training for female veterans with PTSD because of military sexual trauma. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Domestic violence survivors' empowerment and mental health: Exploring the role of the alliance with advocates. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Trauma-focused guided self-help interventions for posttraumatic stress disorder: A meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Single session effects of treatment components within a specialized inpatient posttraumatic stress disorder program. [2019]

6. United States 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. [2022]

7. United States 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. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Making sense of poor adherence in PTSD treatment from the perspectives of veterans and their therapists. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Symptom exacerbations in trauma-focused treatments: Associations with treatment outcome and non-completion. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]

11. United States 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). [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Development of a guided self-help (GSH) program for the treatment of mild-to-moderate posttraumatic stress disorder (PTSD). [2013]

13. Canada pubmed.ncbi.nlm.nih.gov

Chinese My Trauma Recovery, a Web-based intervention for traumatized persons in two parallel samples: randomized controlled trial. [2021]