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Building Experience for Treating Trauma and Enhancing Resilience (BETTER)

Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05330442
Acronym
BETTER
Enrollment
720
Registered
2022-04-15
Start date
2022-04-25
Completion date
2027-07-26
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

PTSD, brief psychotherapy, collaborative care, Federally Qualified Health Centers (FQHCs), primary care

Brief 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. 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.

Interventions

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.

Sponsors

RAND
Lead SponsorOTHER
Boston University
CollaboratorOTHER
Clinical Directors Network
CollaboratorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors will not know which are patients within health centers are assigned to because they will be independent of the participant recruitment coordinators.

Intervention model description

Matched pairs of health centers/FQHCs will be randomized to either CoCM alone or to CoCM+WET.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist, version 5 (PCL-5)baselinePTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

Secondary

MeasureTime frameDescription
Patient Health Questionnaire, 8 items (PHQ-8)baselineDepression symptoms (total score) and probable diagnosis
Veterans RAND 12-item Health Survey (VR-12)baselineMental and physical health functioning component scores

Countries

United States

Contacts

STUDY_DIRECTORJessica Higby

RAND

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026