Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05330442 |
| Other study ID # |
MH123585 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2022 |
| Est. completion date |
June 14, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
RAND |
| Contact |
LISA S MEREDITH, PhD |
| Phone |
310.393.0411 |
| Email |
seidel[@]rand.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
