Trial Outcomes & Findings for Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans (NCT NCT00706901)
NCT ID: NCT00706901
Last Updated: 2018-08-08
Results Overview
Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
Arm 1 GMI
Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
Arm 2 IHMD
Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
Arm 3 TCC
Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
62
|
59
|
|
Overall Study
COMPLETED
|
51
|
57
|
51
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
8
|
Reasons for withdrawal
| Measure |
Arm 1 GMI
Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
Arm 2 IHMD
Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
Arm 3 TCC
Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
5
|
|
Overall Study
In Jail
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans
Baseline characteristics by cohort
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In-Home-Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control condition
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
62 participants
n=7 Participants
|
59 participants
n=5 Participants
|
180 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) daysPopulation: Intent to treat population (at least one GMI session attended)
Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
5.1 Days Using Alcohol
Standard Deviation 7.6
|
6.5 Days Using Alcohol
Standard Deviation 9.5
|
6.7 Days Using Alcohol
Standard Deviation 10.3
|
|
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
8.8 Days Using Alcohol
Standard Deviation 13.3
|
10.9 Days Using Alcohol
Standard Deviation 16.3
|
9.9 Days Using Alcohol
Standard Deviation 18.8
|
PRIMARY outcome
Timeframe: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) daysPopulation: Intent to treat population (at least one GMI session attended)
Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
3.1 Days of binge drinking
Standard Deviation 6.5
|
2.7 Days of binge drinking
Standard Deviation 6.5
|
6.1 Days of binge drinking
Standard Deviation 10.5
|
|
Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
5.1 Days of binge drinking
Standard Deviation 10.8
|
4.0 Days of binge drinking
Standard Deviation 10.5
|
7.9 Days of binge drinking
Standard Deviation 17.7
|
PRIMARY outcome
Timeframe: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysPopulation: Intent to treat population (at least one GMI session attended)
Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
45.1 Standard alcohol drinks
Standard Deviation 98.1
|
45.8 Standard alcohol drinks
Standard Deviation 100.7
|
70.0 Standard alcohol drinks
Standard Deviation 131.1
|
|
Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
66.5 Standard alcohol drinks
Standard Deviation 156.6
|
64.6 Standard alcohol drinks
Standard Deviation 129.7
|
112.3 Standard alcohol drinks
Standard Deviation 251.9
|
PRIMARY outcome
Timeframe: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysPopulation: Intent to treat population (at least one GMI session attended)
Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
8.7 Number of treatment sessions
Standard Deviation 8.7
|
7.0 Number of treatment sessions
Standard Deviation 9.6
|
8.8 Number of treatment sessions
Standard Deviation 9.0
|
|
Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
11.3 Number of treatment sessions
Standard Deviation 13.2
|
6.4 Number of treatment sessions
Standard Deviation 9.8
|
8.3 Number of treatment sessions
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysPopulation: Intent to treat population (at least one GMI session attended)
Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous \[AA/NA\]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell \& Sobell, 1992).
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
8.0 Number of 12-step sessions attended
Standard Deviation 12.0
|
5.1 Number of 12-step sessions attended
Standard Deviation 8.8
|
7.1 Number of 12-step sessions attended
Standard Deviation 29.6
|
|
Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
16.2 Number of 12-step sessions attended
Standard Deviation 22.4
|
10.6 Number of 12-step sessions attended
Standard Deviation 16.6
|
16.2 Number of 12-step sessions attended
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysPopulation: Intent to treat population (at least one GMI session attended)
Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Outcome measures
| Measure |
Arm 1 GMI
n=59 Participants
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 Participants
In Home Messaging Device
|
Arm 3 TCC
n=59 Participants
Treatment Control Condition
|
|---|---|---|---|
|
Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
One month follow up
|
0.74 Days of drug use
Standard Deviation 1.6
|
0.62 Days of drug use
Standard Deviation 2.3
|
0.7 Days of drug use
Standard Deviation 1.6
|
|
Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Three month follow up
|
0.9 Days of drug use
Standard Deviation 2.0
|
0.51 Days of drug use
Standard Deviation 1.6
|
0.7 Days of drug use
Standard Deviation 2.0
|
Adverse Events
Arm 1 GMI
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 IHMD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3 TCC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 GMI
n=59 participants at risk
Group Motivational Interviewing
|
Arm 2 IHMD
n=62 participants at risk
In Home Messaging Device
|
Arm 3 TCC
n=59 participants at risk
Treatment Control Condition
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.7%
1/59 • Number of events 59
|
0.00%
0/62
|
0.00%
0/59
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to throat cancer
|
1.7%
1/59 • Number of events 59
|
0.00%
0/62
|
0.00%
0/59
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place