Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI (MFG-mTBI)

• ClinicalTrials.gov Identifier: NCT02057081
• Recruitment Status: Completed
• First Posted: February 6, 2014
• Results First Posted: June 4, 2020
• Last Update Posted: June 4, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Mild Traumatic Brain Injury; Posttraumatic Stress Disorders; Depression
• Interventions: Behavioral: Multifamily Group for mTBI for Couples; Behavioral: Group Health Education (GHE)
• Enrollment: 249

Participant Flow

Recruitment Details
Pre-assignment Details	One participant was consented but their partner did not consent.

Arm/Group Title	Treatment	Control
Arm/Group Description	Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. 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.	Didactic 14-session educational group intervention for families. 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.
Period Title: Overall Study
Started [1]	136	112
Completed Baseline [2]	88	80
Post-Treatment Assessment [1]	58	52
Completed [1]	46	44
Not Completed	90	68
[1] Includes both veteran and partner participants; [2] Veterans and partners who were consented, randomized, completed baseline and deemed eligible

Baseline Characteristics

Arm/Group Title		Treatment	Control	Total
Arm/Group Description		Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. 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.	Didactic 14-session educational group intervention for families. 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.	Total of all reporting groups
Overall Number of Baseline Participants		88	80	168
Baseline Analysis Population Description		Reflects demographic characteristics of those participants who consent, were randomized and completed the baseline assessment (does not include those that were enrolled and did not complete or who were ineligible)
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	87 participants	80 participants	167 participants
		37.7 (9.1)	36.2 (9.2)	37.0 (9.2)
		[1] Measure Analysis Population Description: Age is missing for one participant assigned to the experimental treatment condition
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	88 participants	80 participants	168 participants
	Female	44 50.0%	40 50.0%	84 50.0%
	Male	44 50.0%	40 50.0%	84 50.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	88 participants	80 participants	168 participants
	American Indian or Alaska Native	0 0.0%	1 1.3%	1 0.6%
	Asian	3 3.4%	2 2.5%	5 3.0%
	Native Hawaiian or Other Pacific Islander	2 2.3%	0 0.0%	2 1.2%
	Black or African American	32 36.4%	24 30.0%	56 33.3%
	White	44 50.0%	36 45.0%	80 47.6%
	More than one race	4 4.5%	5 6.3%	9 5.4%
	Unknown or Not Reported	3 3.4%	12 15.0%	15 8.9%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	88 participants	80 participants	168 participants
		88 100.0%	80 100.0%	168 100.0%
Relationship Status; Measure Type: Count of Participants; Unit of measure: Participants
Married	Number Analyzed	88 participants	80 participants	168 participants
		56 63.6%	50 62.5%	106 63.1%
Cohabitating	Number Analyzed	88 participants	80 participants	168 participants
		24 27.3%	24 30.0%	48 28.6%
Engaged	Number Analyzed	88 participants	80 participants	168 participants
		8 9.1%	6 7.5%	14 8.3%

Outcome Measures

1. Primary Outcome

Title	Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Description	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).
Time Frame	baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44

Outcome Measure Data

Analysis Population Description

Only veteran participants were administered and evaluated on this outcome (not their partners). Two participants from the treatment group and 3 participants from the control group were missing data for this outcome at baseline.

Arm/Group Title		Treatment	Control
Arm/Group Description:		Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. 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.	Didactic 14-session educational group intervention for families. 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.
Overall Number of Participants Analyzed		42	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline: Extent of Participation Subscale	Number Analyzed	42 participants	37 participants
		36.4 (7.8)	35.0 (5.4)
Post-Treatment: Extent of Participation Subscale	Number Analyzed	24 participants	19 participants
		38.2 (6.4)	35.1 (6.1)
6-Month Follow-Up: Extent of Participation Subscal	Number Analyzed	20 participants	16 participants
		37.6 (7.9)	38.0 (6.5)
Baseline: Perceived Limitations Subscale	Number Analyzed	41 participants	36 participants
		41.0 (4.9)	41.0 (4.9)
Post-Treatment: Perceived Limitations Subscale	Number Analyzed	24 participants	19 participants
		41.7 (5.1)	41.3 (4.8)
6-Month Follow-Up: Perceived Limitations Subscale	Number Analyzed	20 participants	16 participants
		41.1 (4.7)	42.3 (4.5)
Baseline: Satisfaction Subscale	Number Analyzed	41 participants	36 participants
		39.8 (6.0)	39.9 (4.5)
Post-Treatment: Satisfaction Subscale	Number Analyzed	24 participants	19 participants
		41.0 (5.7)	40.3 (4.7)
6-Month Follow-Up: Satisfaction Subscale	Number Analyzed	20 participants	16 participants
		39.3 (3.4)	38.9 (7.9)

2. Secondary Outcome

Title	Change in Caregiver Burden Inventory
Description	The Caregiver Burden Inventory is a 24-item scale that measures caregiver burden in four areas: physical, social, emotional and time dependence burden. A total score is calculated by summing the item responses (range= 1 to 100), with higher scores indicating greater caregiver burden.
Time Frame	Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44

Outcome Measure Data

Analysis Population Description

Only partner/spouse participants were administered and evaluated on this outcome (not veterans).

Arm/Group Title		Treatment	Control
Arm/Group Description:		Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. 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.	Didactic 14-session educational group intervention for families. 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.
Overall Number of Participants Analyzed		44	40
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	44 participants	40 participants
		24.9 (20.0)	25.8 (16.5)
Post-treatment	Number Analyzed	26 participants	23 participants
		24.8 (22.3)	25.6 (15.0)
6-month Post-Treatment	Number Analyzed	19 participants	20 participants
		21.5 (19.0)	27.1 (20.1)

Adverse Events

Time Frame	Duration of participants involvement in the study, up to ~ 16 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment	Control
Arm/Group Description	Intensive 14-session psychoeducational rehabilitation and skills-building intervention for couples. 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.	Didactic 14-session educational group intervention for families. 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.
All-Cause Mortality
	Treatment	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/136 (0.00%)	0/112 (0.00%)
Serious Adverse Events
	Treatment	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/136 (4.41%)	4/112 (3.57%)
Immune system disorders
Medical hospitalization *	1/136 (0.74%)	1/112 (0.89%)
Pregnancy, puerperium and perinatal conditions
Medical hospitalization *	0/136 (0.00%)	1/112 (0.89%)
Psychiatric disorders
psychiatric hospitalization *	0/136 (0.00%)	1/112 (0.89%)
Respiratory, thoracic and mediastinal disorders
Medical hospitalization *	1/136 (0.74%)	1/112 (0.89%)
Social circumstances
self-reported interpersonal violence * [1]	3/136 (2.21%)	0/112 (0.00%)
Surgical and medical procedures
medical hospitalization *	1/136 (0.74%)	0/112 (0.00%)
* Indicates events were collected by non-systematic assessment; [1] Self-reported physical altercation with partner
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/136 (0.00%)	0/112 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Amy Drapalski
• Organization: VISN 5 Mental Illness Research, Education, and Clinical Center
• Phone: 410-637-1855
• EMail: amy.drapalski@va.gov

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02057081
• Other Study ID Numbers: D1106-R; 1I01RX001106 ( U.S. NIH Grant/Contract )
• First Submitted: January 22, 2014
• First Posted: February 6, 2014
• Results First Submitted: March 13, 2020
• Results First Posted: June 4, 2020
• Last Update Posted: June 4, 2020