Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing

NCT ID: NCT04241094

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loved one assisted treatment

The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.

Group Type: EXPERIMENTAL

Loved one assisted treatment

Intervention Type: BEHAVIORAL

The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.

Interventions

Loved one assisted treatment

The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in VHA care
• Clinically significant PTSD symptoms
• Have a LO (loved one/intimate partner) with whom they have been in a romantic relationship with for 6 months
• Will allow a LO to participate
• Willing to be seen via telehealth when in-person treatment options aren't available.

Exclusion Criteria

• Actively suicidal/homicidal with intent and/or plan
• Episode of mania/ psychosis in past 3 months
• Severe substance use problem in past 3 months
• Moderate relationship violence
• Veteran has underlying medical condition or a planned medical procedure likely to impair ability to engage in treatment.
• LO screens positive for PTSD
• Veteran and/or LO fails to complete baseline survey

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A. Meis, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D3460-P

Identifier Type: -

Identifier Source: org_study_id