Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI (MFG-mTBI)
|ClinicalTrials.gov Identifier: NCT02057081|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury Posttraumatic Stress Disorders Depression||Behavioral: Multifamily Group for mTBI for Couples Behavioral: Group Health Education (GHE)||Not Applicable|
Mild traumatic brain injury (mTBI), an injury or concussion associated with brief loss of consciousness or altered mental state, has affected as many as 35% of soldiers wounded during recent military actions in Iraq and Afghanistan. Up to 30% of those injured report persistent somatic, emotional and cognitive post-concussive symptoms (PCS) which may adversely impact family life and community re-integration. Marital conflict and intimate partner violence, reported by 54% of OEF/OIF couples, and co-occurring mental health problems may exacerbate cognitive dysfunction and delay rehabilitation. A key contributor to marital conflict is a lack of knowledge about the Veteran's condition and the skills needed to help him compensate for common deficits in memory and planning which create challenges in household management. Despite a growing evidence base for couples treatment for PTSD, there is no established family-based treatment for OEF/OIF Veterans with mTBI, creating a critical research and services gap. The proposed research aims to fill this gap by evaluating a novel form of multi-family group treatment designed to improve community integration (CI) among married/cohabiting OEF/OIF Veterans with mTBI and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by training spouse/partners to aid with rehabilitation and employing disability-adapted communication and problem-solving skills to reduce marital conflict and improve marital satisfaction.
Veterans (N=150) with a positive Defense and Veterans Brain Injury Center (DVBIC) screen for mTBI sustained during the OEF/OIF era, confirmed by the VA Identification Clinical Interview and a Montreal Cognitive Assessment (MoCA) score 19 or if they either meet diagnostic criteria for PTSD or have trauma- or CS of at least moderate severity, as defined by either a) PTSD Checklist (PCL) score >34 or b) Customer Effort Score (CES) score of >23, will be randomized to receive either: 1) Multifamily Group for TBI for Couples (MFG-mTBI-C), a psychoeducational, rehabilitation and skills-building intervention consisting of a 2-session multifamily educational workshop providing information about TBI and 12 bi-monthly multifamily group meetings providing skills training in problem-solving and communication related to cognitive/emotional deficits; or 2) 14 bi-monthly multifamily group sessions delivering health education without skills training. Both treatments will be preceded by 2-3 individual couples sessions. Participants will be assessed pre- and post-treatment and 6 months post-treatment. Data will be analyzed using an intent-to-treat analysis with paired comparisons between treatment groups on primary (Veteran CI, caregiver burden) and secondary (anger management, use of social supports) outcome variables using mixed effects regression models. It is hypothesized that: 1) Veterans treated with MFG-mTBI-C will show improved CI, anger management and use of social support, and spouse/partners will show reduced burden compared with those treated in the health education group; 2) that improvement in CI will be mediated by improvement in marital satisfaction and Veteran anger management and social support; 3) that Veterans with more intact cognitive functioning at baseline will show greater improvement in CI, anger management, social support and marital satisfaction. If efficacious, MFG-mTBI-C has the potential to assist Veterans with mTBI and their partners throughout the VA Health Care System.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI|
|Actual Study Start Date :||October 9, 2014|
|Estimated Primary Completion Date :||March 2, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Intensive 12-session psychoeducational rehabilitation and skills-building intervention for couples.
Behavioral: Multifamily Group for mTBI for Couples
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.
Other Name: MFG-mTBI-C
Active Comparator: Control
Didactic 14-session educational group intervention for families.
Behavioral: Group Health Education (GHE)
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.
Other Name: GHE
No Intervention: Epigenetic
Optional blood draw at Bronx site only to investigate epigenetic biomarkers of treatment.
- Change in The Computer Adaptive Test version of the Community Reintegration of Injured Service Members (CRIS-CAT) [ Time Frame: pre-treatment in study month 5, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 ]The CRIS assesses community reintegration through the assessment of participation in life roles. Items on the CRIS cover 9 aspects of participation: 1) Learning and Applying Knowledge, 2) General Tasks and Demands, 3) Communication, 4) Mobility, 5) Self-care, 6) Domestic Life, 7) Interpersonal Relationships, 8) Major Life Areas, and 9) Community, Social, and Civic Life.
- Change in Caregiver Burden Inventory [ Time Frame: pre-treatment in study month 5, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44 ]A 24-item scale that will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057081
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY|
|Bronx, New York, United States, 10468|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|
|New York, New York, United States, 10010|
|Principal Investigator:||Amy Lynne Drapalski, PhD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|