PTSDEMPOWERNCT05797441
Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy
A study testing EMPOWER and Treatment As Usual in people with PTSD and Post Traumatic Stress Disorder, run by VA Office of Research and Development at 8 sites in United States.
Trial summary
Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- EMPOWER and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Oct 2023to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible to participate if they:
- complete a course of individually-delivered TFT with a study therapist at a participating site
- experience a clinically meaningful change in PTSD symptomology
- at the time of enrollment (in either the TAU or EMPOWER arm), are not planning to initiate another weekly psychotherapy for PTSD for another mental or psychosocial condition within 3 months
- are willing to receive to either arm
- provide informed consent
Who cannot join
- Patients will be excluded if they report suicidal ideation that requires clinical monitoring at baseline
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209-1638
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Empowering Veterans to Self-Manage PTSD Symptoms Following Completion of Trauma-Focused Therapy
Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.
Read the detailed description
Background. Nearly 90% of Veterans who complete trauma-focused therapy (TFT) for PTSD have remaining treatment needs. In the six-months following TFT, successful completers remain some of the highest utilizers of VA mental health services despite clinically meaningful symptom improvement. Prior work demonstrated that Veterans who benefitted from TFT's primary post-TFT treatment needs were the practice and application of skills learned during therapy, with the goal of maintaining or building upon treatment gains. Veterans expressed low self-efficacy for meeting these goals without the support of their therapists and feared stagnation or relapse without ongoing contact. As such, a therapist-assisted self-management program for TFT completers (EMPOWER) designed as a step down from active psychotherapy was developed and feasibility tested. The feasibility open trial demonstrated that EMPOWER is feasible and highly acceptable to patients. Further, findings suggest that the intervention was successful in helping Veterans maintain or enhance PTSD-related gains while reducing their mental health service utilization. These promising findings warrant a randomized evaluation.
Significance. Interventions that meet Veterans' post-TFT treatment needs are urgently needed. Mental health providers are delivering ongoing treatment to this high priority cohort of Veterans without evidence to guide their treatment plan. Further, higher than expected levels of post-TFT mental health care utilization threatens the continued implementation of these highly effective treatments. For all Veterans to have access to the most effective treatments for PTSD, interventions that prepare and enable successful TFT completers to step down from active therapy must evaluated and implemented.
Innovation. The proposed study is the first large-scale study of post-TFT care and the first to rigorously evaluate a self-management program to step-down from active to maintenance mental health services following a course of active psychotherapy.
Specific Aims: 1) Estimate posterior probability distributions of EMPOWER's effects and establish likely ranges for those effects as compared to post-TFT TAU for Veterans' MH service utilization and self-reported PTSD symptoms. The subsequent Hybrid RCT will be designed after assessing the likelihood of detecting an effect for EMPOWER across a range of sample sizes using Go/No Go and Overall Power methods. 2) Explore the impact of EMPOWER compared to post-TFT TAU on Veterans'(a) self-efficacy for managing PTSD symptoms, (b) satisfaction with post-TFT care, (c) well-being \& functioning (d) depression, and (e) secondary utilization outcomes. 3) Conduct semi-structured interviews with Veterans and providers to contextualize quantitative findings and identify potential barriers, facilitators, and strategies to facilitate future implementation of EMPOWER.
Methodology: The study is a pragmatic randomized control trial (RCT) in which 36 PE and CPT providers will be randomized to support Veterans as they participate in the EMPOWER self-management program or facilitate TAU. Participants will be patients of the study providers who recently completed a course of PE/CPT during which they experienced clinically meaningful reductions in PTSD symptoms (n=90). Primary outcomes will be mental health service utilization (overall and with PE/CPT providers) and self-reported PTSD symptoms measured four times over a 9-month period. Qualitative interviews with providers (n=18) and Veterans (n=24) focused on providers' impressions of treatment effectiveness, implementation challenges/potential strategies, and Veterans' perception of treatment effectiveness.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- EMPOWER, Treatment As Usual
- Keywords
- Post Traumatic Stress Disorders, PTSD, Self-Management
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
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.
Treatment As UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER | Experimental | 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. Receives: Behavioral: EMPOWER |
| Treatment As Usual | Active comparator | 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. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist-5 (PCL-5)
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
Measured: 12 weeks post treatment initiation
Veterans' Affairs Mental Health Service Utilization
All encounters with a mental health stop code in the Veterans Health Administration; variable is a count of total encounters
Measured: 9 month period from treatment initiation to 9 months later
PTSD Checklist-5 (PCL-5)
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
Measured: 24 weeks post treatment initiation
PTSD Checklist-5 (PCL-5)
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
Measured: 40 weeks post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start16 Oct 2023
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Conducting a planning RCT in preparation for a fully powered trial using a parallel two-group pragmatic RCT design in which providers (n = 36) will be randomized at a 2:1 ratio to deliver either EMPOWER (n = 60) or TAU (n = 30) to veterans who have completed prolonged exposure or cognitive processing therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shannon M. Kehle-Forbes, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797441
- Sponsor's protocol ID
- IIR 20-102
- Acronym
- EMPOWER
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Veterans to Self-Manage PTSD Symptoms Following Completion of Trauma-Focused Therapy
- ClinicalTrials.gov ID
- NCT05797441
- Acronym / sponsor ID
- EMPOWER / IIR 20-102
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorders, PTSD, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.
Detailed description
Background. Nearly 90% of Veterans who complete trauma-focused therapy (TFT) for PTSD have remaining treatment needs. In the six-months following TFT, successful completers remain some of the highest utilizers of VA mental health services despite clinically meaningful symptom improvement. Prior work demonstrated that Veterans who benefitted from TFT's primary post-TFT treatment needs were the practice and application of skills learned during therapy, with the goal of maintaining or building upon treatment gains. Veterans expressed low self-efficacy for meeting these goals without the support of their therapists and feared stagnation or relapse without ongoing contact. As such, a therapist-assisted self-management program for TFT completers (EMPOWER) designed as a step down from active psychotherapy was developed and feasibility tested. The feasibility open trial demonstrated that EMPOWER is feasible and highly acceptable to patients. Further, findings suggest that the intervention was successful in helping Veterans maintain or enhance PTSD-related gains while reducing their mental health service utilization. These promising findings warrant a randomized evaluation.
Significance. Interventions that meet Veterans' post-TFT treatment needs are urgently needed. Mental health providers are delivering ongoing treatment to this high priority cohort of Veterans without evidence to guide their treatment plan. Further, higher than expected levels of post-TFT mental health care utilization threatens the continued implementation of these highly effective treatments. For all Veterans to have access to the most effective treatments for PTSD, interventions that prepare and enable successful TFT completers to step down from active therapy must evaluated and implemented.
Innovation. The proposed study is the first large-scale study of post-TFT care and the first to rigorously evaluate a self-management program to step-down from active to maintenance mental health services following a course of active psychotherapy.
Specific Aims: 1) Estimate posterior probability distributions of EMPOWER's effects and establish likely ranges for those effects as compared to post-TFT TAU for Veterans' MH service utilization and self-reported PTSD symptoms. The subsequent Hybrid RCT will be designed after assessing the likelihood of detecting an effect for EMPOWER across a range of sample sizes using Go/No Go and Overall Power methods. 2) Explore the impact of EMPOWER compared to post-TFT TAU on Veterans'(a) self-efficacy for managing PTSD symptoms, (b) satisfaction with post-TFT care, (c) well-being \& functioning (d) depression, and (e) secondary utilization outcomes. 3) Conduct semi-structured interviews with Veterans and providers to contextualize quantitative findings and identify potential barriers, facilitators, and strategies to facilitate future implementation of EMPOWER.
Methodology: The study is a pragmatic randomized control trial (RCT) in which 36 PE and CPT providers will be randomized to support Veterans as they participate in the EMPOWER self-management program or facilitate TAU. Participants will be patients of the study providers who recently completed a course of PE/CPT during which they experienced clinically meaningful reductions in PTSD symptoms (n=90). Primary outcomes will be mental health service utilization (overall and with PE/CPT providers) and self-reported PTSD symptoms measured four times over a 9-month period. Qualitative interviews with providers (n=18) and Veterans (n=24) focused on providers' impressions of treatment effectiveness, implementation challenges/potential strategies, and Veterans' perception of treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Conducting a planning RCT in preparation for a fully powered trial using a parallel two-group pragmatic RCT design in which providers (n = 36) will be randomized at a 2:1 ratio to deliver either EMPOWER (n = 60) or TAU (n = 30) to veterans who have completed prolonged exposure or cognitive processing therapy.
| Arm | Type | Receives |
|---|---|---|
| EMPOWER | Experimental | Behavioral: EMPOWERThe 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. |
| Treatment As Usual | Active comparator | Other: Treatment As UsualThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be eligible to participate if they:
Key exclusion criteria (1 listed)
- Patients will be excluded if they report suicidal ideation that requires clinical monitoring at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWERThe 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. | Behavioural | EMPOWER |
| Treatment As UsualThe 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. | Other | Treatment As Usual |
Primary outcome
PTSD Checklist-5 (PCL-5)
Time frame: 12 weeks post treatment initiation
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
Veterans' Affairs Mental Health Service Utilization
Time frame: 9 month period from treatment initiation to 9 months later
All encounters with a mental health stop code in the Veterans Health Administration; variable is a count of total encounters
PTSD Checklist-5 (PCL-5)
Time frame: 24 weeks post treatment initiation
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
PTSD Checklist-5 (PCL-5)
Time frame: 40 weeks post treatment initiation
PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M. Kehle-Forbes, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER and Treatment As Usual in people with PTSD and Post Traumatic Stress Disorder, run by VA Office of Research and Development at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-5 (PCL-5) (time frame: 12 weeks post treatment initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.