What side effects are associated with this type of intervention?

Common treatments for PTSD, such as prolonged exposure therapy and cognitive processing therapy, are generally well-tolerated but can sometimes lead to temporary increases in distress or anxiety as patients confront traumatic memories. Pharmacotherapy with SSRIs (e.g., sertraline) and SNRIs (e.g., venlafaxine) can cause side effects such as nausea, insomnia, sexual dysfunction, and increased sweating. These medications may also lead to weight gain and, in some cases, exacerbate anxiety or agitation initially. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by increasing serotonin levels in the brain. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine have been used off-label for PTSD. For ongoing support and independent symptom management, therapies such as prolonged exposure and cognitive processing therapy are commonly employed, and these can be augmented with medications like SSRIs to enhance treatment outcomes. The Therapist-Assisted Self-Management Program aims to build on these established treatments by providing continued support and strategies to maintain symptom improvement and reduce the need for frequent mental health appointments.

What other types of research exist?

Promising novel alternatives for PTSD treatment in 2024 include: 1) The 'From Survivor to Thriver' program, an interactive, online therapist-facilitated cognitive-behavioral program specifically for rape-related PTSD, which has shown significant reductions in PTSD symptoms. 2) Technology-enhanced delivery of CBT-based interventions, such as web-based training and smartphone applications, which have demonstrated efficacy in improving treatment outcomes. 3) Combined pharmacotherapy and psychological therapies, which have been effective in treating PTSD, as evidenced by trials combining prolonged exposure therapy with medications like paroxetine.

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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 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.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Checklist-5 (PCL-5)

Veterans' Affairs Mental Health Service Utilization

Other study objectives

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

~100

Do I qualify?Apply below to find out

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

1,647 Previous Clinical Trials

3,359,980 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

~56 spots leftby Mar 2026

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