Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04241094 |
| Other study ID # |
D3460-P |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
PTSD occurs in as many as 17% of US military Veterans and is associated with a host of
negative, long-term consequences to the individual, their families, and society at large.
EBPs, such as Prolonged Exposure, result in clinically significant symptom relief for many.
Yet, these therapies have proven less effective for military personnel and Veterans and
treatment dropout rates are high. The investigators' team surveyed Veterans initiating EBPs
for PTSD and a family member across four VA medical centers (N = 598; Project HomeFront). The
investigators found that Veterans were more than twice as likely to complete EBPs when loved
ones encouraged them to confront distress and that Veterans experienced greater treatment
gains when they shared more with their loved ones about their treatment. A couples-based,
exposure therapy for PTSD that integrates intimate partners into every session of PE could
provide the opportunity to mobilize the whole household in the service of EBP engagement,
while extending the goals of therapy beyond symptom reduction to family functioning. The
investigators anticipate this intervention will teach couples to embrace a lifestyle that
supports confronting trauma-related distress, so the Veteran and his/her family can achieve
optimal functional outcomes.
Description:
The investigators aim to improve the mental health, family functioning, and well-being of
Veterans with posttraumatic stress disorder (PTSD) through developing and evaluating a
trauma-focused, couple therapy for PTSD. The investigators will use strategies from
Integrative Behavioral Couple Therapy (ICBT) to help intimate partners support Veterans
during exposure therapy for PTSD (Prolonged Exposure; PE). The investigators anticipate this
approach will increase Veterans' engagement in PE, but also improve relationship functioning,
family functioning, and social functioning. Family involvement has been highlighted as a
fertile avenue for improving the outcomes for patients with PTSD, yet families are
infrequently integrated into evidence-based psychotherapies (EBPs). The investigators' goals
are highly consistent with RR&D's mission to promote research that leverages family support
as a pathway to reintegration and optimizes meaningful recovery and functioning.
Objectives. The investigators will complete stages 1A and 1B of the Stage Model of Treatment
Development. Specifically, the investigators will: (1) Expand the treatment outline using
content experts and feedback from key stakeholders (Veterans, intimate partners, providers,
and VA mental health leadership). (2) Conduct a pilot open trial to assess (a) the
acceptability of treatment components, structure, and materials, (b) the feasibility of the
intervention (retention and intervention fidelity), and (c) the study approach (screening,
recruitment, and assessment process). (3) Explore the preliminary effects of the intervention
on select outcomes including overall functioning, mental health functioning, social
functioning, family functioning, and potential mechanisms (social control, subjective norms,
and the degree to which Veterans rely on their partners for support).
Methods: To accomplish Aim 1, the investigators will expand the outline for the intervention
into an initial treatment manual through meetings with content experts and stakeholder
feedback. Next, the investigators will develop fidelity checklists and revise the treatment
manual through conducting the intervention with 2-3 couples. To accomplish Aims 2 and 3, the
investigators will evaluate the intervention in a non-randomized, open trial with 10 Veterans
diagnosed with PTSD and their intimate partners. Veterans will complete baseline and
posttreatment structured diagnostic interviews. Both members of the couple will complete
baseline surveys, posttreatment surveys, and posttreatment qualitative exit interviews. Using
data obtained from the open trial, the investigators will assess the intervention's
acceptability, feasibility, mechanisms, and outcomes. Upon completion of this proposal, the
investigators will be well positioned to apply for Merit funding for a randomized clinical
trial (Stage 2 of the Stage Model of Treatment Development) of this innovative, exposure
based, couple therapy.
