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

NCT04241094 | Completed Results

• 1 other identifier: D3460-P
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Couples therapy; Psychotherapy; Veterans

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.

  Structured clinical interview assessing symptoms of PTSD. CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Severity scores range from 0 to 80 and higher scores correspond with more severe symptoms of PTSD.

  Up to 26 weeks post baseline

Study Arms (1)

Loved one assisted treatment

EXPERIMENTAL

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.

Behavioral: Loved one assisted treatment

Interventions

Loved one assisted treatment 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.

Loved one assisted treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Small number of subjects analyzed

Results Point of Contact

• Title: Laura Meis, PhD
• Organization: Center for Care Delivery & Outcomes Research

laura.meis@va.gov

651-467-4516

Study Officials

• Laura A. Meis, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Open trial

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: November 2, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)