CompletedNot Applicable

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

United States249 participantsStarted 2014-10-09

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Eligible Veterans must have a diagnosis of mTBI in accordance with the VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury: injury or concussion associated with at least one of the following: brief (\< 30 minutes) loss of consciousness or altered state of consciousness or post-traumatic amnesia for \< 24 hours following the injury, or they either meet diagnostic criteria for PTSD based on the MINI or have trauma- or CS of at least moderate severity, as defined by either: a) PCL score \>34; or b) CES score of \>23. * The TBI must be either blast-related or attributable to another discrete event (e.g., fall, fight, injury) sustained during deployment in the OEF/OIF era. * Post-concussive symptoms (e.g., sleep or memory problems, headache) must not be attributable to a subsequent injury or other pre-existing or concurrent neurologic disorder: * Eligible Veterans must also have a consenting, qualifying spouse/cohabiting partner and a Montreal Cognitive Assessment (MoCA) (Nasreddine,2005) score 19. * The 30-item MoCA screens for impairment in specific areas of cognitive functioning deemed necessary for participation in a 90-minute, structured group including attention and concentration, executive functions, language and conceptual thinking. * We have specified a MoCA cut-off at the lower end of the range for mild cognitive dysfunction (19), in order to exclude Veterans with severe memory and/or other cognitive deficits,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)

Timeframe: baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44

Trial details

NCT IDNCT02057081

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-03-12

Results submitted2020-03-13

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials