Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
MFG-mTBI
2 other identifiers
interventional
249
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedStudy Start
First participant enrolled
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedJune 4, 2020
May 1, 2020
4.4 years
January 22, 2014
March 13, 2020
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
The Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT) was used to measure community reintegration. The measure includes 3 subscales: Extent of Participation, Perceived Limitations, and Satisfaction. A total score for each subscale is calculated by summing item responses (range= 10 to 140), with higher scores indicating greater frequency of community participation (extent of participation), greater perceived limitations to community participation (perceived limitations), and greater satisfaction with community participation (satisfaction).
baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44
Secondary Outcomes (1)
Change in Caregiver Burden Inventory
Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44
Study Arms (2)
Treatment
EXPERIMENTALIntensive 14-session psychoeducational rehabilitation and skills-building intervention for couples.
Control
ACTIVE COMPARATORDidactic 14-session educational group intervention for families.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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, while admitting those with more mild deficits, as these represent our target population, i.e. Veterans with a history of mTBI.
You may not qualify if:
- a lifetime diagnosis of a major psychiatric disorder (schizophrenia, schizoaffective or bipolar disorder with psychotic features) or active psychosis based on the Structured Clinical Interview for DSM-IV-TR (SCID-L) (First et al., 2007).
- alcohol or drug abuse or dependence with past 6 months defined by a Short Michigan Alcoholism Screening Test (SMAST) (Selzer, 1975) 3, based on the recommended cut-off for TBI survivors (Gentilello et al.,1995) or a Drug Abuse Screening Test-10 (DAST-10) (Skinner, 1982) 3.
- "severe" inter-partner violence as defined by the revised 20-item Conflict Tactics Scale Short Form (CTS2S) (Straus \& Douglas, 2004).
- a suicide attempt within the past 6 months (aborted and interrupted attempts) as assessed by the Columbia Suicide Severity Rating scale (C-SSRS).
- medical condition or life event (e.g., ongoing or pending legal action in another state) that would compromise participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010, United States
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amy Drapalski
- Organization
- VISN 5 Mental Illness Research, Education, and Clinical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amy L Drapalski, PhD
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
February 6, 2014
Study Start
October 9, 2014
Primary Completion
March 12, 2019
Study Completion
August 31, 2019
Last Updated
June 4, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share