PTSDBETTERNCT05330442
Building Experience for Treating Trauma and Enhancing Resilience (BETTER)
A study testing Written Exposure Therapy (WET) in people with PTSD, run by RAND at 10 sites in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is a significant problem among underserved populations who receive care in community health centers. Several evidence-based psychotherapies for PTSD are not practical given the time and resources required for these approaches. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Written Exposure Therapy (WET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Apr 2022to 26 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included if they are 18 years of age or older, speak English or Spanish, have a scheduled or walk-in appointment with a participating primary care provider (PCP), have no obvious physical or cognitive impairment that would make them unable to complete the assessment (as indicated by confusion or inability to understand the questions), and consider the FQHC to be their usual source of care.
Who cannot join
- Patients will be excluded if they have active psychosis (as indicated by inability to concentrate, having delusions or hallucinations) or high suicide risk (as indicated by having a current plan or means).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Oak Orchard Health Center (Albion)
Albion, New York, 14411
Brownsville Health Center (Genesis and Ashford - BGA)
Brooklyn, New York, 11212
Brownsville Health Center (Main)
Brooklyn, New York, 11212
Bedford Stuyvesant Family Health Center (Main)
Brooklyn, New York, 11216
Bedford Stuyvesant Family Health Center (Sterling and Broadway)
Brooklyn, New York, 11216
Oak Orchard Health (Pembroke)
Corfu, New York, 14036
Open Door Family Medical Center (Brewster/Ossining)
Ossining, New York, 10562
Open Door Family Medical Center (Mamaroneck//Port Chester)
Port Chester, New York, 10573
OIC Family Medical Center (Fairview)
Rocky Mount, North Carolina, 27801
OIC Family Medical Center (Happy Hill)
Rocky Mount, North Carolina, 27804
About this study
Official title: Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings
Posttraumatic stress disorder (PTSD) is a significant problem among underserved populations who receive care in community health centers. Several evidence-based psychotherapies for PTSD are not practical given the time and resources required for these approaches. This research will examine whether Written Exposure Therapy (WET), a brief and well-tolerated therapy approach, delivered within collaborative primary care is effective and can be implemented successfully within a collaborative care (CC) intervention. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs).
Read the detailed description
Posttraumatic stress disorder (PTSD) results in substantial costs to society is highly prevalent among adults. Importantly, the prevalence PTSD within primary care settings is even higher than the general population as primary care is the setting to which individuals with PTSD most often present. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination within real world settings is fraught with challenges because these therapies require 10-15, lengthy treatment sessions and extensive therapist training to implement, and these treatments are not feasible within primary care settings given the limited time resources. Consequently, there are multiple barriers to accessing EBPs for PTSD. Efforts to integrate mental health services within primary care for PTSD though collaborative care management (CoCM) interventions are rapidly expanding and have been shown to be effective in the treatment of depression and anxiety. However, the evidence for PTSD is limited due to the time intensive nature of the PTSD therapy approaches that have been examined. An efficient PTSD treatment approach is needed to address the treatment needs of individuals with PTSD presenting to primary care. Written exposure therapy (WET) is a brief EBP that provides an alternative to more intensive EBPs. Recent studies of WET have yielded positive outcomes and have shown it to be non-inferior when directly compared to more time intensive PTSD EBPs, but WET has not yet been examined within the primary care environment. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs). The pragmatic cluster-randomized study will use a hybrid effectiveness-implementation design. Twelve FQHCs will be randomized to either CoCM plus WET (CoCM+WET) or CoCM alone and 60 patients within each FQHC will be screened for eligibility. The investigators will use the RE-AIM framework (for Reach, Efficacy/Effectiveness, Adoption, Implementation, \& Maintenance) to evaluate the effectiveness and implementation process of the CoCM+WET intervention using mixed methods. To examine effectiveness and potential mediators and moderators of the intervention, the investigators will administer assessments at baseline, 3- and 12-month follow-up. To assess implementation, the investigators will use clinic process data and clinic staff interviews pre- and post-intervention. This study has the potential to substantially impact practice and public health by validating the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care to improve PTSD outcomes for underserved patients.
- Conditions
- PTSD
- Being tested
- Written Exposure Therapy (WET)
- Keywords
- PTSD, brief psychotherapy, collaborative care, Federally Qualified Health Centers (FQHCs), primary care
- 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.
Written Exposure Therapy (WET)Behavioural
The WET protocol for primary care settings consists of six, 30-minute sessions. The first session consists of psychoeducation of PTSD and treatment rationale. Written narratives are conducted in sessions 2-6, following specific writing instructions and 20 minutes of writing in each session.
| Study group | Role | What they receive |
|---|---|---|
| CoCM alone | No intervention | In the CoCM alone arm, participants will have access to treatment as usual from the CM. |
| CoCM+WET | Experimental | In the CoCM+WET intervention arm, patients will be encouraged to receive WET. Receives: Behavioral: Written Exposure Therapy (WET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist, version 5 (PCL-5)
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
Measured: baseline
PTSD Checklist, version 5 (PCL-5)
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
Measured: 3-months
PTSD Checklist, version 5 (PCL-5)
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
Measured: 12-months
Secondary outcomes (6)
Patient Health Questionnaire, 8 items (PHQ-8)
Depression symptoms (total score) and probable diagnosis
Measured: baseline
Patient Health Questionnaire, 8 items (PHQ-8)
Depression symptoms (total score) and probable diagnosis
Measured: 3-months
Patient Health Questionnaire, 8 items (PHQ-8)
Depression symptoms (total score) and probable diagnosis
Measured: 12-months
Veterans RAND 12-item Health Survey (VR-12)
Mental and physical health functioning component scores
Measured: baseline
Veterans RAND 12-item Health Survey (VR-12)
Mental and physical health functioning component scores
Measured: 3-months
Veterans RAND 12-item Health Survey (VR-12)
Mental and physical health functioning component scores
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Apr 2022
- Primary completion31 Jul 2026
- Study completion26 Jul 2027 (estimated)
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.
- 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
- Matched pairs of health centers/FQHCs will be randomized to either CoCM alone or to CoCM+WET.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Clinical Directors Network
- Responsible party
- Sponsor
- Investigators
- Jessica Higby, Study director, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330442
- Sponsor's protocol ID
- MH123585
- Acronym
- BETTER
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, the research programmer will upload participant data to the NIMH Data Archive.
Publications
Meredith LS, Wong EC, Marx BP, Han B, Korn AR, Tobin JN, Cassells A, Williamson S, Franco M, Overa CC, Holder T, Lin TJ, Sloan DM. Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings. Contemp Clin Trials. 2024 Mar;138:107435. doi: 10.1016/j.cct.2024.107435. Epub 2024 Jan 9.
PubMed 38211725
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings
- ClinicalTrials.gov ID
- NCT05330442
- Acronym / sponsor ID
- BETTER / MH123585
- Conditions
- PTSD
- Keywords
- PTSD, brief psychotherapy, collaborative care, Federally Qualified Health Centers (FQHCs), primary care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Boston University, Clinical Directors Network
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 26 Jul 2027 (estimated)
- First posted
- 15 Apr 2022 (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.
Posttraumatic stress disorder (PTSD) is a significant problem among underserved populations who receive care in community health centers. Several evidence-based psychotherapies for PTSD are not practical given the time and resources required for these approaches. This research will examine whether Written Exposure Therapy (WET), a brief and well-tolerated therapy approach, delivered within collaborative primary care is effective and can be implemented successfully within a collaborative care (CC) intervention. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs).
Detailed description
Posttraumatic stress disorder (PTSD) results in substantial costs to society is highly prevalent among adults. Importantly, the prevalence PTSD within primary care settings is even higher than the general population as primary care is the setting to which individuals with PTSD most often present. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination within real world settings is fraught with challenges because these therapies require 10-15, lengthy treatment sessions and extensive therapist training to implement, and these treatments are not feasible within primary care settings given the limited time resources. Consequently, there are multiple barriers to accessing EBPs for PTSD. Efforts to integrate mental health services within primary care for PTSD though collaborative care management (CoCM) interventions are rapidly expanding and have been shown to be effective in the treatment of depression and anxiety. However, the evidence for PTSD is limited due to the time intensive nature of the PTSD therapy approaches that have been examined. An efficient PTSD treatment approach is needed to address the treatment needs of individuals with PTSD presenting to primary care. Written exposure therapy (WET) is a brief EBP that provides an alternative to more intensive EBPs. Recent studies of WET have yielded positive outcomes and have shown it to be non-inferior when directly compared to more time intensive PTSD EBPs, but WET has not yet been examined within the primary care environment. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs). The pragmatic cluster-randomized study will use a hybrid effectiveness-implementation design. Twelve FQHCs will be randomized to either CoCM plus WET (CoCM+WET) or CoCM alone and 60 patients within each FQHC will be screened for eligibility. The investigators will use the RE-AIM framework (for Reach, Efficacy/Effectiveness, Adoption, Implementation, \& Maintenance) to evaluate the effectiveness and implementation process of the CoCM+WET intervention using mixed methods. To examine effectiveness and potential mediators and moderators of the intervention, the investigators will administer assessments at baseline, 3- and 12-month follow-up. To assess implementation, the investigators will use clinic process data and clinic staff interviews pre- and post-intervention. This study has the potential to substantially impact practice and public health by validating the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care to improve PTSD outcomes for underserved patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Matched pairs of health centers/FQHCs will be randomized to either CoCM alone or to CoCM+WET.
| Arm | Type | Receives |
|---|---|---|
| CoCM alone | No intervention | –In the CoCM alone arm, participants will have access to treatment as usual from the CM. |
| CoCM+WET | Experimental | Behavioral: Written Exposure Therapy (WET)In the CoCM+WET intervention arm, patients will be encouraged to receive WET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be included if they are 18 years of age or older, speak English or Spanish, have a scheduled or walk-in appointment with a participating primary care provider (PCP), have no obvious physical or cognitive impairment that would make them unable to complete the assessment (as indicated by confusion or inability to understand the questions), and consider the FQHC to be their usual source of care.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have active psychosis (as indicated by inability to concentrate, having delusions or hallucinations) or high suicide risk (as indicated by having a current plan or means).
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 |
|---|---|---|
| Written Exposure Therapy (WET)The WET protocol for primary care settings consists of six, 30-minute sessions. The first session consists of psychoeducation of PTSD and treatment rationale. Written narratives are conducted in sessions 2-6, following specific writing instructions and 20 minutes of writing in each session. | Behavioural | CoCM+WET |
Primary outcome
PTSD Checklist, version 5 (PCL-5)
Time frame: baseline
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
PTSD Checklist, version 5 (PCL-5)
Time frame: 3-months
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
PTSD Checklist, version 5 (PCL-5)
Time frame: 12-months
PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event
6 secondary outcomes
Patient Health Questionnaire, 8 items (PHQ-8)
Time frame: baseline
Patient Health Questionnaire, 8 items (PHQ-8)
Time frame: 3-months
Patient Health Questionnaire, 8 items (PHQ-8)
Time frame: 12-months
Veterans RAND 12-item Health Survey (VR-12)
Time frame: baseline
Veterans RAND 12-item Health Survey (VR-12)
Time frame: 3-months
Veterans RAND 12-item Health Survey (VR-12)
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 38211725Meredith LS, Wong EC, Marx BP, Han B, Korn AR, Tobin JN, Cassells A, Williamson S, Franco M, Overa CC, Holder T, Lin TJ, Sloan DM. Design of a hybrid implementation effectiveness cluster randomized controlled trial of delivering written exposure therapy for PTSD in underserved primary care settings. Contemp Clin Trials. 2024 Mar;138:107435. doi: 10.1016/j.cct.2024.107435. Epub 2024 Jan 9.
- Individual participant dataSharing planned: Yes. At the end of the study, the research programmer will upload participant data to the NIMH Data Archive.
Related trials for PTSD
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
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.
Jessica Higby study director
RAND
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy (WET) in people with PTSD, run by RAND at 10 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 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
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, version 5 (PCL-5) (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT05330442, 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 14 Aug 2026.