Building Experience for Treating Trauma and Enhancing Resilience (BETTER)

NCT ID: NCT05330442

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2026-06-30

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CoCM alone

In the CoCM alone arm, participants will have access to treatment as usual from the CM.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CoCM+WET

In the CoCM+WET intervention arm, patients will be encouraged to receive WET.

Group Type: EXPERIMENTAL

Written Exposure Therapy (WET)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Higby

Role: STUDY_DIRECTOR

RAND

Locations

Oak Orchard Health Center (Albion)

Albion, New York, United States

Brownsville Health Center (Genesis and Ashford - BGA)

Brooklyn, New York, United States

Brownsville Health Center (Main)

Brooklyn, New York, United States

Bedford Stuyvesant Family Health Center (Main)

Brooklyn, New York, United States

Bedford Stuyvesant Family Health Center (Sterling and Broadway)

Brooklyn, New York, United States

Oak Orchard Health (Pembroke)

Corfu, New York, United States

Open Door Family Medical Center (Brewster/Ossining)

Ossining, New York, United States

Open Door Family Medical Center (Mamaroneck//Port Chester)

Port Chester, New York, United States

OIC Family Medical Center (Fairview)

Rocky Mount, North Carolina, United States

OIC Family Medical Center (Happy Hill)

Rocky Mount, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 38211725 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MH123585

Identifier Type: -

Identifier Source: org_study_id