CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Family Supported Prolonged Exposure +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Male or female veterans at least 18 years old, enrolled in VHA care
  • Meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD (criteria A, F, G plus at least one symptom from each remaining criterion)
  • Has an intimate partner, family member, or friend with whom they have contact at least 3 times a week
  • Willing to allow the identified support person to participate in the study
Key exclusion· 7
  • Current suicidal or homicidal ideation with intent and/or plan
  • Meets DSM-5 criteria for a manic or psychotic episode in the past 3 months
  • Meets DSM-5 diagnostic criteria for severe substance use disorder in the past 3 months (nicotine and marijuana abuse/dependence allowed)
  • Moderate relationship violence with support person: one or more episodes of severe violence in past year (e.g., punched, kicked, beat up)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03256227
NCT03256227N/ACompleted

Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

VA Office of Research and Development·interventional·Posted Aug 21, 2017·Updated Jun 14, 2024

In Brief

A clinical study evaluating Family Supported Prolonged Exposure and Standard Prolonged Exposure for Posttraumatic Stress Disorder. Completed, enrolled 128 participants across 3 sites.

Detailed Summary

Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartJan 15, 2018
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.9 years ago

Interventions

Family Supported Prolonged Exposurebehavioral

The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.

Standard Prolonged Exposurebehavioral

Standard Prolonged Exposure for PTSD as delivered in routine VA care.