Clinical trial NCT05330442: Building Experience for Treating Trauma and Enhancing Resilience (BETTER)
Official title: Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: PTSD
brief psychotherapy
collaborative care
Federally Qualified Health Centers (FQHCs)
primary care
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Boston University
name: Clinical Directors Network
First posted: 2022-04-15
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched pairs of health centers/FQHCs will be randomized to either CoCM alone or to CoCM+WET.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: PTSD Checklist, version 5 (PCL-5)
timeFrame: baseline
measure: PTSD Checklist, version 5 (PCL-5)
timeFrame: 3-months
measure: PTSD Checklist, version 5 (PCL-5)
timeFrame: 12-months
Secondary outcomes:
measure: Patient Health Questionnaire, 8 items (PHQ-8)
timeFrame: baseline
measure: Patient Health Questionnaire, 8 items (PHQ-8)
timeFrame: 3-months
measure: Patient Health Questionnaire, 8 items (PHQ-8)
timeFrame: 12-months
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: baseline
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: 3-months
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: 12-months
Other outcomes:
Locations:
city: Albion
country: United States
facility: Oak Orchard Health Center (Albion)
state: New York
city: Brooklyn
country: United States
facility: Brownsville Health Center (Genesis and Ashford - BGA)
state: New York
city: Brooklyn
country: United States
facility: Brownsville Health Center (Main)
state: New York
city: Brooklyn
country: United States
facility: Bedford Stuyvesant Family Health Center (Main)
state: New York
city: Brooklyn
country: United States
facility: Bedford Stuyvesant Family Health Center (Sterling and Broadway)
state: New York
city: Corfu
country: United States
facility: Oak Orchard Health (Pembroke)
state: New York
city: Ossining
country: United States
facility: Open Door Family Medical Center (Brewster/Ossining)
state: New York
city: Port Chester
country: United States
facility: Open Door Family Medical Center (Mamaroneck//Port Chester)
state: New York
city: Rocky Mount
country: United States
facility: OIC Family Medical Center (Fairview)
state: North Carolina
city: Rocky Mount
country: United States
facility: OIC Family Medical Center (Happy Hill)
state: North Carolina
Study officials:
affiliation: RAND
name: Jessica Higby
role: STUDY_DIRECTOR
References:
citation: 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.