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

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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:
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
Recruitment Details  
Pre-assignment Details One participant was consented but their partner did not consent.
Arm/Group Title Treatment Control
Hide 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
Arm/Group Title Treatment Control Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only partner/spouse participants were administered and evaluated on this outcome (not veterans).
Arm/Group Title Treatment Control
Hide 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)
Time Frame Duration of participants involvement in the study, up to ~ 16 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide 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%) 
Hide 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
Hide 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%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amy Drapalski
Organization: VISN 5 Mental Illness Research, Education, and Clinical Center
Phone: 410-637-1855
EMail: amy.drapalski@va.gov
Layout table for additonal information
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