CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 249 enrolled
Drug / intervention
Multifamily Group for mTBI for Couples +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02057081
NCT02057081N/ACompleted

Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI

VA Office of Research and Development·interventional·Posted Feb 6, 2014·Updated Jun 4, 2020

In Brief

A clinical study evaluating Multifamily Group for mTBI for Couples and Group Health Education (GHE) for Mild Traumatic Brain Injury and 2 related conditions. Completed, enrolled 249 participants across 3 sites.

Detailed Summary

This project addresses the rehabilitation and mental health needs of married combat Veterans post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by providing psychoeducation, communication and problem solving skills in a multifamily group (MFG) setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic strategies to help compensate for deficits and promote Veteran community integration, interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of the skills-based MFG will be compared to that of a health education group which offers a supportive environment and basic education without skills training through a randomized clinical trial. As there is currently no family-based intervention for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum of services, this intervention fills a crucial gap in healthcare for our newest Veterans.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2014
Enrollment StartOct 9, 2014
Primary CompletionMar 12, 2019
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.4 years ago

Interventions

Multifamily Group for mTBI for Couplesbehavioral

MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges.

Group Health Education (GHE)behavioral

GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas.