Trial Outcomes & Findings for Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI (NCT NCT02057081)
NCT ID: NCT02057081
Last Updated: 2020-06-04
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44
Results posted on
2020-06-04
Participant Flow
One participant was consented but their partner did not consent.
Participant milestones
| Measure |
Treatment
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.
|
Control
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 Study
STARTED
|
136
|
112
|
|
Overall Study
Completed Baseline
|
88
|
80
|
|
Overall Study
Post-Treatment Assessment
|
58
|
52
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
90
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age is missing for one participant assigned to the experimental treatment condition
Baseline characteristics by cohort
| Measure |
Treatment
n=88 Participants
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.
|
Control
n=80 Participants
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
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 9.1 • n=87 Participants • Age is missing for one participant assigned to the experimental treatment condition
|
36.2 years
STANDARD_DEVIATION 9.2 • n=80 Participants • Age is missing for one participant assigned to the experimental treatment condition
|
37.0 years
STANDARD_DEVIATION 9.2 • n=167 Participants • Age is missing for one participant assigned to the experimental treatment condition
|
|
Sex: Female, Male
Female
|
44 Participants
n=88 Participants
|
40 Participants
n=80 Participants
|
84 Participants
n=168 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=88 Participants
|
40 Participants
n=80 Participants
|
84 Participants
n=168 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=88 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=88 Participants
|
2 Participants
n=80 Participants
|
5 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=88 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=88 Participants
|
24 Participants
n=80 Participants
|
56 Participants
n=168 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=88 Participants
|
36 Participants
n=80 Participants
|
80 Participants
n=168 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=88 Participants
|
5 Participants
n=80 Participants
|
9 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=88 Participants
|
12 Participants
n=80 Participants
|
15 Participants
n=168 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=88 Participants
|
80 Participants
n=80 Participants
|
168 Participants
n=168 Participants
|
|
Relationship Status
Married
|
56 Participants
n=88 Participants
|
50 Participants
n=80 Participants
|
106 Participants
n=168 Participants
|
|
Relationship Status
Cohabitating
|
24 Participants
n=88 Participants
|
24 Participants
n=80 Participants
|
48 Participants
n=168 Participants
|
|
Relationship Status
Engaged
|
8 Participants
n=88 Participants
|
6 Participants
n=80 Participants
|
14 Participants
n=168 Participants
|
PRIMARY outcome
Timeframe: baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44Population: 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.
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).
Outcome measures
| Measure |
Treatment
n=42 Participants
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.
|
Control
n=37 Participants
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.
|
|---|---|---|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Baseline: Extent of Participation Subscale
|
36.4 score on a scale
Standard Deviation 7.8
|
35.0 score on a scale
Standard Deviation 5.4
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Post-Treatment: Extent of Participation Subscale
|
38.2 score on a scale
Standard Deviation 6.4
|
35.1 score on a scale
Standard Deviation 6.1
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
6-Month Follow-Up: Extent of Participation Subscal
|
37.6 score on a scale
Standard Deviation 7.9
|
38.0 score on a scale
Standard Deviation 6.5
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Baseline: Perceived Limitations Subscale
|
41.0 score on a scale
Standard Deviation 4.9
|
41.0 score on a scale
Standard Deviation 4.9
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Post-Treatment: Perceived Limitations Subscale
|
41.7 score on a scale
Standard Deviation 5.1
|
41.3 score on a scale
Standard Deviation 4.8
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
6-Month Follow-Up: Perceived Limitations Subscale
|
41.1 score on a scale
Standard Deviation 4.7
|
42.3 score on a scale
Standard Deviation 4.5
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Baseline: Satisfaction Subscale
|
39.8 score on a scale
Standard Deviation 6.0
|
39.9 score on a scale
Standard Deviation 4.5
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
Post-Treatment: Satisfaction Subscale
|
41.0 score on a scale
Standard Deviation 5.7
|
40.3 score on a scale
Standard Deviation 4.7
|
|
Change in the Community Reintegration of Injured Service Members Computer Adaptive Test (CRIS-CAT)
6-Month Follow-Up: Satisfaction Subscale
|
39.3 score on a scale
Standard Deviation 3.4
|
38.9 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline, post-treatment in study month 38 after 12 bimonthly sessions, and 6-months post-treatment in study month 44Population: Only partner/spouse participants were administered and evaluated on this outcome (not veterans).
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.
Outcome measures
| Measure |
Treatment
n=44 Participants
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.
|
Control
n=40 Participants
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.
|
|---|---|---|
|
Change in Caregiver Burden Inventory
Baseline
|
24.9 score on a scale
Standard Deviation 20.0
|
25.8 score on a scale
Standard Deviation 16.5
|
|
Change in Caregiver Burden Inventory
Post-treatment
|
24.8 score on a scale
Standard Deviation 22.3
|
25.6 score on a scale
Standard Deviation 15.0
|
|
Change in Caregiver Burden Inventory
6-month Post-Treatment
|
21.5 score on a scale
Standard Deviation 19.0
|
27.1 score on a scale
Standard Deviation 20.1
|
Adverse Events
Treatment
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=136 participants at risk
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.
|
Control
n=112 participants at risk
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.
|
|---|---|---|
|
Social circumstances
self-reported interpersonal violence
|
2.2%
3/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.00%
0/112 • Duration of participants involvement in the study, up to ~ 16 months
|
|
Psychiatric disorders
psychiatric hospitalization
|
0.00%
0/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.89%
1/112 • Duration of participants involvement in the study, up to ~ 16 months
|
|
Surgical and medical procedures
medical hospitalization
|
0.74%
1/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.00%
0/112 • Duration of participants involvement in the study, up to ~ 16 months
|
|
Pregnancy, puerperium and perinatal conditions
Medical hospitalization
|
0.00%
0/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.89%
1/112 • Duration of participants involvement in the study, up to ~ 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Medical hospitalization
|
0.74%
1/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.89%
1/112 • Duration of participants involvement in the study, up to ~ 16 months
|
|
Immune system disorders
Medical hospitalization
|
0.74%
1/136 • Duration of participants involvement in the study, up to ~ 16 months
|
0.89%
1/112 • Duration of participants involvement in the study, up to ~ 16 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amy Drapalski
VISN 5 Mental Illness Research, Education, and Clinical Center
Phone: 410-637-1855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place