Building Experience for Treating Trauma and Enhancing Resilience (BETTER)

NCT05330442 | Active Not Recruiting DMC

• 1 other identifier: MH123585
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 10

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).

Conditions

PTSD

Keywords

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

Outcome Measures

Primary Outcomes (3)

• PTSD Checklist, version 5 (PCL-5)

  PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

  baseline

• PTSD Checklist, version 5 (PCL-5)

  PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

  3-months

• PTSD Checklist, version 5 (PCL-5)

  PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

  12-months

Secondary Outcomes (6)

• Patient Health Questionnaire, 8 items (PHQ-8)

  baseline

• Patient Health Questionnaire, 8 items (PHQ-8)

  3-months

• Patient Health Questionnaire, 8 items (PHQ-8)

  12-months

• Veterans RAND 12-item Health Survey (VR-12)

  baseline

• Veterans RAND 12-item Health Survey (VR-12)

  3-months

Study Arms (2)

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.

Behavioral: Written Exposure Therapy (WET)

Interventions

Written Exposure Therapy (WET) 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.

CoCM+WET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• RAND: lead
• Boston University: collaborator
• Clinical Directors Network: collaborator

Study Sites (10)

Oak Orchard Health Center (Albion)

Albion, New York, 14411, United States

Location

Brownsville Health Center (Genesis and Ashford - BGA)

Brooklyn, New York, 11212, United States

Location

Brownsville Health Center (Main)

Brooklyn, New York, 11212, United States

Location

Bedford Stuyvesant Family Health Center (Main)

Brooklyn, New York, 11216, United States

Location

Bedford Stuyvesant Family Health Center (Sterling and Broadway)

Brooklyn, New York, 11216, United States

Location

Oak Orchard Health (Pembroke)

Corfu, New York, 14036, United States

Location

Open Door Family Medical Center (Brewster/Ossining)

Ossining, New York, 10562, United States

Location

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

Port Chester, New York, 10573, United States

Location

OIC Family Medical Center (Fairview)

Rocky Mount, North Carolina, 27801, United States

Location

OIC Family Medical Center (Happy Hill)

Rocky Mount, North Carolina, 27804, United States

Location

Related Publications (1)

• 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.

  PMID: 38211725 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jessica Higby

  RAND

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not know which are patients within health centers are assigned to because they will be independent of the participant recruitment coordinators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 15, 2022
• Study Start: April 25, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: May 2026
• Access Criteria: Data will be shared through the NIMH Data Archive

Locations

US (10)