PTSDNCT02982538
Implementation of Prolonged Exposure in the Military
A study testing Extended Training in Prolonged Exposure Therapy for PTSD and Standard Training in Prolonged Exposure Therapy for PTSD in people with PTSD, run by University of Pennsylvania at 3 sites in United States.
Trial summary
This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Extended Training in Prolonged Exposure Therapy for PTSD and Standard Training in Prolonged Exposure Therapy for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Sep 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- FOR PROVIDERS: 1) Male and female behavioral health providers whose job duties include providing psychotherapy to adult patients, age ≥ 18,seeking treatment with symptoms of PTS. Behavioral health providers can include psychologists, social workers, psychiatric clinical nurse specialists, psychiatrists, and similarly trained professional providers.2) Twenty percent (or more) of expected caseload comprised of patients with PTS symptoms according to provider self-report.
- FOR PATIENTS: 1) Male and female patients age ≥ 18. 2) Receiving treatment from one of the behavioral health providers participating in this study. 3) Significant PTS symptoms as determined by a score of 25 or higher on The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Who cannot join
- FOR PROVIDERS: 1) Definite plans to terminate their position or relocate from the Army base at some point during the first year following training. 2) Extensive previous training in Prolonged Exposure (PE), defined as participation in a 4-day PE training workshop at any point prior to the start of the study, and self-reported use of PE (including both imaginal and in vivo exposure techniques) to treat 4 or more patients with PTS symptoms in the past year.
- FOR PATIENTS: 1) Current bipolar disorder I or psychotic disorder (as determined by the MINI). 2) Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires). 3) Current suicidal ideation severe enough to warrant immediate attention (as determined by the MINI and the Beck Scale for Suicidal Ideation).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Evans Army Community Hospital (EACH), Ft. Carson
Colorado Springs, Colorado, 80913
William Beaumont Army Medical Center (WBAMC), Ft. Bliss
El Paso, Texas, 79906
Blanchfield Army Community Hospital (BACH), Ft. Campbell
Fort Campbell North, Kentucky, 42223
About this study
Official title: Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?
This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. The study compares two PE training models: Standard PE training, comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop plus expert case consultation. In addition, patients with posttraumatic stress symptoms receiving psychotherapy from participating providers will be invited to participate. After completing PE training, use of PE components with patients reporting PTS symptoms and clinical outcomes of these participating patients will be monitored for up to 18 months.
Read the detailed description
This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE) for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in the Army by comparing two PE training models: Standard PE training (workshop only) and Extended PE training (workshop plus consultation). Up to 180 mental health providers at three medium-to large Army installations will be randomly assigned to either Standard PE training or Extended PE training. All providers will complete a 4-day PE workshop, along with the distribution of training materials and treatment manuals, conducted at the military site by the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants randomized to the Extended PE training will receive weekly phone consultation with a PE expert on two PE therapy cases. Participants randomized to the Standard PE training group will not receive any additional consultation following the workshop. Providers will not be required to use PE therapy with their patients with PTS symptoms; using PE will be optional. A major outcome of this study is the proportion of the providers PTSD patients that are offered PE or PE components. The mental health outcomes of providers' PTS patients will also be monitored as a second major outcome. Patients seeking treatment from participating providers will be recruited, consented, and assessed by independent evaluators at two time points to prospectively assess their response to treatment.
- Conditions
- PTSD
- Being tested
- Extended Training in Prolonged Exposure Therapy for PTSD, Standard Training in Prolonged Exposure Therapy for PTSD
- Keywords
- posttraumatic stress symptoms, implementation, dissemination, PTSD
- 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.
Extended Training in Prolonged Exposure Therapy for PTSDBehavioural
Extended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing).
Standard Training in Prolonged Exposure Therapy for PTSDBehavioural
Standard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army.
| Study group | Role | What they receive |
|---|---|---|
| Standard PE Training Condition | Other | Providers in this condition will complete a 4-day training workshop in PE. Receives: Behavioral: Standard Training in Prolonged Exposure Therapy for PTSD |
| Extended PE Training Condition | Other | Providers in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation. Receives: Behavioral: Extended Training in Prolonged Exposure Therapy for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Use of PE Components
Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Provider Attitudes
Provider change in self-efficacy and attitudes toward PE will be assessed via a self-report measure administered before and after the PE workshop, and at 3 month intervals until 18 months following the conclusion of training.
Measured: Through study completion, an average of 2 years
Patient Posttraumatic Stress Outcomes
Patient posttraumatic stress symptom severity will be assessed via using the PTSD Symptom Scale - Interview, administered following referral to the study and after 8-15 sessions of therapy, or after 5 months since initial assessment, whichever comes first.
Measured: 8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startOct 2012
- Primary completionSep 2018
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Principal investigator, Edna Foa, University of Pennsylvania
- Investigators
- Edna B Foa, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982538
- Sponsor's protocol ID
- W81XWH-12-2-0116
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2016
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Foa EB, McLean CP, Brown LA, Zang Y, Rosenfield D, Zandberg LJ, Ealey W, Hanson BS, Hunter LR, Lillard IJ, Patterson TJ, Rosado J, Scott V, Weber C, Wise JE, Zamora CD, Mintz J, Young-McCaughan S, Peterson AL; STRONG STAR Consortium. The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Implement Sci. 2020 Jul 29;15(1):59. doi: 10.1186/s13012-020-01014-x.
PubMed 32727509
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?
- ClinicalTrials.gov ID
- NCT02982538
- Acronym / sponsor ID
- W81XWH-12-2-0116
- Conditions
- PTSD
- Keywords
- posttraumatic stress symptoms, implementation, dissemination, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- Oct 2012 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. The study compares two PE training models: Standard PE training, comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop plus expert case consultation. In addition, patients with posttraumatic stress symptoms receiving psychotherapy from participating providers will be invited to participate. After completing PE training, use of PE components with patients reporting PTS symptoms and clinical outcomes of these participating patients will be monitored for up to 18 months.
Detailed description
This study will examine how evidence-based therapies (EBTs) such as Prolonged Exposure (PE) for posttraumatic stress disorder (PTSD) can be successfully disseminated and implemented in the Army by comparing two PE training models: Standard PE training (workshop only) and Extended PE training (workshop plus consultation). Up to 180 mental health providers at three medium-to large Army installations will be randomly assigned to either Standard PE training or Extended PE training. All providers will complete a 4-day PE workshop, along with the distribution of training materials and treatment manuals, conducted at the military site by the Overall Study PI, Dr. Edna Foa, and her team. Following the 4-day workshop, participants randomized to the Extended PE training will receive weekly phone consultation with a PE expert on two PE therapy cases. Participants randomized to the Standard PE training group will not receive any additional consultation following the workshop. Providers will not be required to use PE therapy with their patients with PTS symptoms; using PE will be optional. A major outcome of this study is the proportion of the providers PTSD patients that are offered PE or PE components. The mental health outcomes of providers' PTS patients will also be monitored as a second major outcome. Patients seeking treatment from participating providers will be recruited, consented, and assessed by independent evaluators at two time points to prospectively assess their response to treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PE Training Condition | Other | Behavioral: Standard Training in Prolonged Exposure Therapy for PTSDProviders in this condition will complete a 4-day training workshop in PE. |
| Extended PE Training Condition | Other | Behavioral: Extended Training in Prolonged Exposure Therapy for PTSDProviders in this condition will complete a 4-day training workshop in PE and will receive expert PE case consultation on two PE training cases via weekly phone consultation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- FOR PROVIDERS: 1) Male and female behavioral health providers whose job duties include providing psychotherapy to adult patients, age ≥ 18,seeking treatment with symptoms of PTS. Behavioral health providers can include psychologists, social workers, psychiatric clinical nurse specialists, psychiatrists, and similarly trained professional providers.2) Twenty percent (or more) of expected caseload comprised of patients with PTS symptoms according to provider self-report.
- FOR PATIENTS: 1) Male and female patients age ≥ 18. 2) Receiving treatment from one of the behavioral health providers participating in this study. 3) Significant PTS symptoms as determined by a score of 25 or higher on The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Key exclusion criteria (2 listed)
- FOR PROVIDERS: 1) Definite plans to terminate their position or relocate from the Army base at some point during the first year following training. 2) Extensive previous training in Prolonged Exposure (PE), defined as participation in a 4-day PE training workshop at any point prior to the start of the study, and self-reported use of PE (including both imaginal and in vivo exposure techniques) to treat 4 or more patients with PTS symptoms in the past year.
- FOR PATIENTS: 1) Current bipolar disorder I or psychotic disorder (as determined by the MINI). 2) Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires). 3) Current suicidal ideation severe enough to warrant immediate attention (as determined by the MINI and the Beck Scale for Suicidal Ideation).
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 |
|---|---|---|
| Extended Training in Prolonged Exposure Therapy for PTSDExtended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing). | Behavioural | Extended PE Training Condition |
| Standard Training in Prolonged Exposure Therapy for PTSDStandard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army. | Behavioural | Standard PE Training Condition |
Primary outcome
Provider Use of PE Components
Time frame: Through study completion, an average of 2 years
Provider use of PE components will be assessed using a brief checklist of treatment procedures completed by providers directly following therapy sessions with participating patients.
2 secondary outcomes
Provider Attitudes
Time frame: Through study completion, an average of 2 years
Patient Posttraumatic Stress Outcomes
Time frame: 8-15 sessions of therapy or after 5 months since initial assessment, whichever comes first
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 11 Jan 2022.
- Derived from this study: PubMed 32727509Foa EB, McLean CP, Brown LA, Zang Y, Rosenfield D, Zandberg LJ, Ealey W, Hanson BS, Hunter LR, Lillard IJ, Patterson TJ, Rosado J, Scott V, Weber C, Wise JE, Zamora CD, Mintz J, Young-McCaughan S, Peterson AL; STRONG STAR Consortium. The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Implement Sci. 2020 Jul 29;15(1):59. doi: 10.1186/s13012-020-01014-x.
- 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.
Edna B Foa, Ph.D. principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Training in Prolonged Exposure Therapy for PTSD and Standard Training in Prolonged Exposure Therapy for PTSD in people with PTSD, run by University of Pennsylvania at 3 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 2 inclusion and 2 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Provider Use of PE Components (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982538, which also lists 1 linked publication.
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 11 Jan 2022.