Posttraumatic Stress DisorderEMPOwERNCT03225859
A Self-Management Program for Completers of Trauma-Focused Therapy for PTSD
A study testing Self-Management Program in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic stress disorder symptoms, quality of life, and social and role functioning. However, many also report uncertainty regarding their ability to maintain and build upon progress made during TFTs following the end of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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:
- completed a course of individually-delivered trauma-focused therapy (TFT) with a provider trained to deliver the self-management intervention at the Minneapolis VAMC
- experienced a clinically meaningful reduction in PTSD symptomology (PCL decrease of at least 10 points) from pre-TFT to the time of the enrollment
- at the time of enrollment are not planning to initiate another active course of psychotherapy for PTSD in the following three months
- are willing to participate in a self-management intervention, and
- can provide informed consent
Who cannot join
- Veterans will be excluded if they have suicidal or homicidal ideation that in the opinion of their TFT therapist needs to be the focus of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: Pilot Test of a Self-Management Program for Completers of Trauma-Focused Therapy
Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic stress disorder symptoms, quality of life, and social and role functioning. However, many also report uncertainty regarding their ability to maintain and build upon progress made during TFTs following the end of treatment. Veterans who recently completed a course of TFT believe the likelihood of their ongoing success would be bolstered by mental health services that support additional practice and reinforcement of skills learned in TFT. Currently no evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs are well-suited to a therapist-assisted self-management approach. The objective of this project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of Treatment Development for a post-TFT therapist-assisted self-management program designed to help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess the acceptability and feasibility of the self-management program, and 3) Explore the effects of the program on Veterans' confidence in managing their PTSD and Veterans' functioning, quality of life, community engagement, and mental health symptoms.
Read the detailed description
Impact: Findings from this project will improve the mental health and well-being of Veterans with posttraumatic stress disorder (PTSD) by refining and evaluating the first post-trauma focused therapy (TFT) intervention designed to help Veterans increase self-efficacy for managing their PTSD symptoms, maintain or build upon gains made in TFT, and increase community engagement. The current VA / Department of Defense PTSD clinical practice guidelines recommend decreasing the frequency and intensity of care (e.g. stepping-down) following successful TFT completion; this project is the initial step in developing the first evidence-based intervention for this important process. The project will advance RR\&D's missions of evaluating interventions designed to maximize psychological recovery and prioritizing functional outcomes and societal engagement. Finally, the project will advance the scientific literature by being the first examination of a self-management intervention designed to be used to step down from an intensive course of therapy for PTSD.
Background: TFTs reduce the suffering associated with PTSD; a majority of Veterans who complete prolonged exposure or cognitive processing therapy report improvements in PTSD symptomology, quality of life, and functioning. Despite their effectiveness, emerging data suggest that Veterans who complete TFTs continue to perceive a need for mental health treatment; the investigators' pilot data demonstrated that the primary post-TFT mental health treatment need among completers who experienced at least a partial improvement in PTSD symptoms is support for additional practice and reinforcement of skills learned in TFT. Veterans expressed low self-efficacy for maintaining or building upon their existing gains and believed continued contact with their TFT therapist would increase their likelihood of success. These treatment needs are particularly well-suited to a therapist-assisted self-management approach. Self-management protocols teach patients to be responsible for the day-to-day management of their symptoms, thereby emphasizing patients' roles in wellness. The existing literature on self-management interventions for PTSD has demonstrated that such approaches are acceptable, safe, and effective; however, they have exclusively been used as stand-alone treatments or as the first step up in a stepped-care model. Therefore, the investigators are proposing the first examination of a self-management intervention designed to be used to step down from an intensive course of TFT for PTSD.
Objectives: The objective of this study is to complete stages 1A and 1B of the Stage Model of Treatment Development for the self-management program for Veterans who have recently completed a course of TFT for PTSD. Specifically, the investigators will: (1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers, (2) Conduct a pilot open trial to assess the (a) acceptability of the self-management program components, structure, and materials and (b) feasibility of the self-management program (retention and intervention fidelity) and study approach (screening, recruitment, assessment process), and (3) Explore the effects of the program on Veterans' confidence in managing their PTSD (self-efficacy), functioning, quality of life, community engagement, and mental health symptoms.
Methods: To achieve Aim 1, the investigators will conduct semi-structured individual interviews with a sample of TFT providers (n = 10-12), during which participants will be asked to provide feedback on the planned components and structure of the self-management program. To achieve Aims 2 and 3, the investigators will enroll twelve Veterans in a non-randomized, open-trial pilot test of the intervention at the Minneapolis VA Healthcare Systems (VAHCS). Enrolled Veterans will complete survey batteries immediately post-TFT, and survey batteries and qualitative interviews two weeks after the final self-management program therapist contact. Findings from this project will strongly position us to apply for Merit funding to conduct a randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this innovative self-management program.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Self-Management Program
- Keywords
- Stress Disorders, Posttraumatic, 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.
Self-Management ProgramBehavioural
This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Program | Experimental | Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD. Receives: Behavioral: Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Credibility-Expectancy Scale (Credibility Subscale)
Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).
Measured: Prior to first self-management session (baseline)
Client Satisfaction Scale
Measures client satisfaction with mental health services (range = 8-32; higher scores = higher satisfaction)
Measured: Three months after first self-management session (follow-up)
Secondary outcomes (7)
Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale)
Measures patients' self-efficacy for managing PTSD symptoms; range = 1-5 (higher scores = greater perceived control; change from pre- to post-intervention reported.
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on PTSD Checklist - 5
Measures DSM-5 PTSD symptoms; Range = 0-80; higher scores = more severe symptoms; change score from pre- to post-treatment reported
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Patient Health Questionnaire - 9
Measures symptoms of depression; range = 0-27; higher scores = more severe symptoms; pre- to post-treatment change score reported
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale)
Measures patients' perceived mental health; range 1-5; lower scores = better perceived mental health
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on World Health Organization Quality of Life - BREF
Measures patients' current quality of life; higher score = better quality of life; range = 0-100. Change score from pre- to post-treatment reported
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Military to Civilian Questionnaire
Measures patients' community engagement; range: 0-4; higher scores = more difficulty; change score from pre- to post-intervention reported
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Brief Inventory of Psychosocial Functioning
Measure of PTSD-related psychosocial functional impairment; higher scores = more severe; range = 0-49; change from pre- to post-treatment reported
Measured: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start5 Nov 2018
- Primary completion17 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study non-randomized, open-trial pilot test of the intervention with twelve Veterans who will all receive the study intervention.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System, Syracuse VA Medical Center
- 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
- NCT03225859
- Sponsor's protocol ID
- D2525-P
- Other IDs
- 1I21RX002525-01A1
- Acronym
- EMPOwER
- Status last verified
- Feb 2021
- First submitted
- 19 Jul 2017
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research datasets included in primary publications resulting from this proposed research will involve large amounts of individual PHI data and cannot reasonably or efficiently be fully deidentified. Investigators will create analytic datasets that can be requested by outside investigators. These data however will remain within the VA firewall and be housed on VINCI data servers. Outside investigators can follow VA procedures and receive training and approval for access within VA firewalls.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Self-Management Program for Completers of Trauma-Focused Therapy
- ClinicalTrials.gov ID
- NCT03225859
- Acronym / sponsor ID
- EMPOwER / D2525-P
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Stress Disorders, Posttraumatic, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System, Syracuse VA Medical Center
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic stress disorder symptoms, quality of life, and social and role functioning. However, many also report uncertainty regarding their ability to maintain and build upon progress made during TFTs following the end of treatment. Veterans who recently completed a course of TFT believe the likelihood of their ongoing success would be bolstered by mental health services that support additional practice and reinforcement of skills learned in TFT. Currently no evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs are well-suited to a therapist-assisted self-management approach. The objective of this project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of Treatment Development for a post-TFT therapist-assisted self-management program designed to help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess the acceptability and feasibility of the self-management program, and 3) Explore the effects of the program on Veterans' confidence in managing their PTSD and Veterans' functioning, quality of life, community engagement, and mental health symptoms.
Detailed description
Impact: Findings from this project will improve the mental health and well-being of Veterans with posttraumatic stress disorder (PTSD) by refining and evaluating the first post-trauma focused therapy (TFT) intervention designed to help Veterans increase self-efficacy for managing their PTSD symptoms, maintain or build upon gains made in TFT, and increase community engagement. The current VA / Department of Defense PTSD clinical practice guidelines recommend decreasing the frequency and intensity of care (e.g. stepping-down) following successful TFT completion; this project is the initial step in developing the first evidence-based intervention for this important process. The project will advance RR\&D's missions of evaluating interventions designed to maximize psychological recovery and prioritizing functional outcomes and societal engagement. Finally, the project will advance the scientific literature by being the first examination of a self-management intervention designed to be used to step down from an intensive course of therapy for PTSD.
Background: TFTs reduce the suffering associated with PTSD; a majority of Veterans who complete prolonged exposure or cognitive processing therapy report improvements in PTSD symptomology, quality of life, and functioning. Despite their effectiveness, emerging data suggest that Veterans who complete TFTs continue to perceive a need for mental health treatment; the investigators' pilot data demonstrated that the primary post-TFT mental health treatment need among completers who experienced at least a partial improvement in PTSD symptoms is support for additional practice and reinforcement of skills learned in TFT. Veterans expressed low self-efficacy for maintaining or building upon their existing gains and believed continued contact with their TFT therapist would increase their likelihood of success. These treatment needs are particularly well-suited to a therapist-assisted self-management approach. Self-management protocols teach patients to be responsible for the day-to-day management of their symptoms, thereby emphasizing patients' roles in wellness. The existing literature on self-management interventions for PTSD has demonstrated that such approaches are acceptable, safe, and effective; however, they have exclusively been used as stand-alone treatments or as the first step up in a stepped-care model. Therefore, the investigators are proposing the first examination of a self-management intervention designed to be used to step down from an intensive course of TFT for PTSD.
Objectives: The objective of this study is to complete stages 1A and 1B of the Stage Model of Treatment Development for the self-management program for Veterans who have recently completed a course of TFT for PTSD. Specifically, the investigators will: (1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers, (2) Conduct a pilot open trial to assess the (a) acceptability of the self-management program components, structure, and materials and (b) feasibility of the self-management program (retention and intervention fidelity) and study approach (screening, recruitment, assessment process), and (3) Explore the effects of the program on Veterans' confidence in managing their PTSD (self-efficacy), functioning, quality of life, community engagement, and mental health symptoms.
Methods: To achieve Aim 1, the investigators will conduct semi-structured individual interviews with a sample of TFT providers (n = 10-12), during which participants will be asked to provide feedback on the planned components and structure of the self-management program. To achieve Aims 2 and 3, the investigators will enroll twelve Veterans in a non-randomized, open-trial pilot test of the intervention at the Minneapolis VA Healthcare Systems (VAHCS). Enrolled Veterans will complete survey batteries immediately post-TFT, and survey batteries and qualitative interviews two weeks after the final self-management program therapist contact. Findings from this project will strongly position us to apply for Merit funding to conduct a randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this innovative self-management program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study non-randomized, open-trial pilot test of the intervention with twelve Veterans who will all receive the study intervention.
| Arm | Type | Receives |
|---|---|---|
| Self-Management Program | Experimental | Behavioral: Self-Management ProgramPatients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- completed a course of individually-delivered trauma-focused therapy (TFT) with a provider trained to deliver the self-management intervention at the Minneapolis VAMC
- experienced a clinically meaningful reduction in PTSD symptomology (PCL decrease of at least 10 points) from pre-TFT to the time of the enrollment
- at the time of enrollment are not planning to initiate another active course of psychotherapy for PTSD in the following three months
- are willing to participate in a self-management intervention, and
- can provide informed consent
Key exclusion criteria (1 listed)
- Veterans will be excluded if they have suicidal or homicidal ideation that in the opinion of their TFT therapist needs to be the focus of treatment.
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 |
|---|---|---|
| Self-Management ProgramThis therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals | Behavioural | Self-Management Program |
Primary outcome
Credibility-Expectancy Scale (Credibility Subscale)
Time frame: Prior to first self-management session (baseline)
Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).
Client Satisfaction Scale
Time frame: Three months after first self-management session (follow-up)
Measures client satisfaction with mental health services (range = 8-32; higher scores = higher satisfaction)
7 secondary outcomes
Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale)
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on PTSD Checklist - 5
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Patient Health Questionnaire - 9
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale)
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on World Health Organization Quality of Life - BREF
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Military to Civilian Questionnaire
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Change From Baseline on Brief Inventory of Psychosocial Functioning
Time frame: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Research datasets included in primary publications resulting from this proposed research will involve large amounts of individual PHI data and cannot reasonably or efficiently be fully deidentified. Investigators will create analytic datasets that can be requested by outside investigators. These data however will remain within the VA firewall and be housed on VINCI data servers. Outside investigators can follow VA procedures and receive training and approval for access within VA firewalls.
Related trials for Posttraumatic Stress Disorder
Recruiting
Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
Traumatic Injury, PTSD
Not yet recruitingPhase 4
Assessing Trauma-related Links Between Affective and Metabolic Systems
Posttraumatic Stress Disorder, Metabolic Syndrome
Not yet recruiting
EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder
Posttraumatic Stress Disorder (PTSD)
Not yet recruiting
Mindful RAVANS Study
mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
Not yet recruitingEarly Phase 1
Predictors & Mechanisms of Adolescent PTSD
Posttraumatic Stress Disorder (PTSD), Trauma Exposure
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Program in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Credibility-Expectancy Scale (Credibility Subscale) (time frame: Prior to first self-management session (baseline)). The study lists 2 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 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.