Building Experience for Treating Trauma and Enhancing Resilience (BETTER)

Study Overview
=================
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.

Official Title
-----------------
Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: Written Exposure Therapy (WET)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Matched pairs of health centers/FQHCs will be randomized to either CoCM alone or to CoCM+WET.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CoCM alone<br>In the CoCM alone arm, participants will have access to treatment as usual from the CM. | |
| Experimental: CoCM+WET<br>In the CoCM+WET intervention arm, patients will be encouraged to receive WET. | Behavioral: Written Exposure Therapy (WET)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire, 9 items (PHQ-9) | Depression symptoms (total score) and probable diagnosis | baseline | 
| Patient Health Questionnaire, 9 items (PHQ-9) | Depression symptoms (total score) and probable diagnosis | 3-months | 
| Patient Health Questionnaire, 9 items (PHQ-9) | Depression symptoms (total score) and probable diagnosis | 12-months | 
| Health Functioning Short Form 12 (SF-12) | Mental and physical health functioning component scores | baseline | 
| Health Functioning Short Form 12 (SF-12) | Mental and physical health functioning component scores | 3-months | 
| Health Functioning Short Form 12 (SF-12) | Mental and physical health functioning component scores | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, brief psychotherapy, collaborative care, Federally Qualified Health Centers (FQHCs), primary care