Skip to content

Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans

Impact of Group Motivational Interviewing for Dually Diagnosed Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00706901
Acronym
GMI-IHMDs
Enrollment
180
Registered
2008-06-30
Start date
2010-05-03
Completion date
2013-09-30
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Drug Dependence, Dual Diagnosis

Keywords

MI, IHMD

Brief summary

Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.

Detailed description

Dually diagnosed Veterans (N = 178) will be recruited from the Charleston, SC VAMC Outpatient Substance Abuse Treatment Center (SATC) and block randomized to TAU, GMI, or IHMD. Patients with alcohol dependence or abuse (including drug abuse) and a nonsubstance-related major Axis I disorder (e.g., bipolar disorder, depression, psychotic disorder) will be eligible for the study. Participants, who were referred to the study at time of triage or during the orientation phase of SATC, will be evaluated at baseline and approximately at a 1 and 3-month follow-up. Primary outcome measures will be alcohol use and treatment utilization as measured by number of days of alcohol use, number of binge alcohol drinking days, and quantity of alcohol consumed (in standard drinks, or SECs), and treatment attendance sessions based on objective CPRS patient medical records (i.e., number of all substance abuse outpatient, other mental health \[e.g., PTSD, depression\], and other substance abuse treatment sessions), and self-reported 12-step (number of self-help AA/NA) sessions, including days consulting with a 12-step or mutual self-help sponsor. Exploratory outcomes measures include number of illicit drug use days (e.g., cocaine, crack, marijuana, opiates, and sedatives). Primary questions: A. Does GMI lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC? Hypothesis: Participants who receive GMI will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period. B. Does IHMD lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC? Hypothesis: Participants who receive IHMD will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period. Exploratory question: Compared to TCC, will GMI and IHMD lead to significantly fewer days of illicit drug use by 3-month follow-up? Hypothesis: Compared to TCC, GMI and IHMD will result in a significant reduction in days of illicit drug use by 3-month follow-up.

Interventions

BEHAVIORALArm 1 GMI

Participants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller & Rollnick 2013) and based on a manualized protocol (Martino & Santa Ana 2013; Santa Ana & Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions.

BEHAVIORALArm 2 IHMD

Participants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation.

BEHAVIORALArm 3 TCC

TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* ability to provide informed consent * reading level at least at the 5th grade level * ability to identify at least one collateral contact * ability to be contacted by telephone at follow-up * access to a working telephone line in the home or residential placement * alcohol use or alcohol and drug use in the 28 days prior to hospitalization and current alcohol dependence (or abuse) or alcohol and drug abuse

Exclusion criteria

* auditory or visual impairment that would interfere with study procedures * scheduled for discharge within 72 hours of initial screening * diagnosis of dementia * inability to speak or understand English * unable to access a landline telephone for the IHMD treatment group

Design outcomes

Primary

MeasureTime frameDescription
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) daysNumber 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).
Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) daysNumber 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).
Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysStandard 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).
Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysTreatment 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.
Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysNumber 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).

Secondary

MeasureTime frameDescription
Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysNumber 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1 GMI
Group Motivational Interviewing
59
Arm 2 IHMD
In-Home-Messaging Device
62
Arm 3 TCC
Treatment Control condition
59
Total180

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath100
Overall StudyIn Jail101
Overall StudyLost to Follow-up232
Overall StudyWithdrawal by Subject425

Baseline characteristics

CharacteristicArm 1 GMITotalArm 3 TCCArm 2 IHMD
Age, Continuous52.9 years
STANDARD_DEVIATION 8.8
52.1 years
STANDARD_DEVIATION 9.9
51.1 years
STANDARD_DEVIATION 10.6
52.3 years
STANDARD_DEVIATION 10.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
32 Participants104 Participants36 Participants36 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants1 Participants1 Participants
Race (NIH/OMB)
White
27 Participants74 Participants22 Participants25 Participants
Region of Enrollment
United States
59 participants180 participants59 participants62 participants
Sex: Female, Male
Female
5 Participants14 Participants5 Participants4 Participants
Sex: Female, Male
Male
54 Participants166 Participants54 Participants58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
2 / 590 / 620 / 59

Outcome results

Primary

Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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).

Time frame: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMINumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up3.1 Days of binge drinkingStandard Deviation 6.5
Arm 1 GMINumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up5.1 Days of binge drinkingStandard Deviation 10.8
Arm 2 IHMDNumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up2.7 Days of binge drinkingStandard Deviation 6.5
Arm 2 IHMDNumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up4.0 Days of binge drinkingStandard Deviation 10.5
Arm 3 TCCNumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up6.1 Days of binge drinkingStandard Deviation 10.5
Arm 3 TCCNumber of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up7.9 Days of binge drinkingStandard Deviation 17.7
p-value: <0.01Zero inflated Poisson model
p-value: 0.0002Zero-hurdle Poisson model
Primary

Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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).

Time frame: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMINumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up5.1 Days Using AlcoholStandard Deviation 7.6
Arm 1 GMINumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up8.8 Days Using AlcoholStandard Deviation 13.3
Arm 2 IHMDNumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up6.5 Days Using AlcoholStandard Deviation 9.5
Arm 2 IHMDNumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up10.9 Days Using AlcoholStandard Deviation 16.3
Arm 3 TCCNumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up6.7 Days Using AlcoholStandard Deviation 10.3
Arm 3 TCCNumber of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up9.9 Days Using AlcoholStandard Deviation 18.8
p-value: <0.01Zero inflated Poisson model
p-value: 0.02zero-hurdle Poisson model
Primary

Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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).

Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMIStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up45.1 Standard alcohol drinksStandard Deviation 98.1
Arm 1 GMIStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up66.5 Standard alcohol drinksStandard Deviation 156.6
Arm 2 IHMDStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up45.8 Standard alcohol drinksStandard Deviation 100.7
Arm 2 IHMDStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up64.6 Standard alcohol drinksStandard Deviation 129.7
Arm 3 TCCStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up70.0 Standard alcohol drinksStandard Deviation 131.1
Arm 3 TCCStandard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up112.3 Standard alcohol drinksStandard Deviation 251.9
p-value: 0.04Weibull mixture model
p-value: 0.47Mixed Models Analysis
Primary

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

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).

Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMITreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up8.0 Number of 12-step sessions attendedStandard Deviation 12
Arm 1 GMITreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up16.2 Number of 12-step sessions attendedStandard Deviation 22.4
Arm 2 IHMDTreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up5.1 Number of 12-step sessions attendedStandard Deviation 8.8
Arm 2 IHMDTreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up10.6 Number of 12-step sessions attendedStandard Deviation 16.6
Arm 3 TCCTreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up7.1 Number of 12-step sessions attendedStandard Deviation 29.6
Arm 3 TCCTreatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up16.2 Number of 12-step sessions attendedStandard Deviation 22.4
p-value: <0.0001Zero inflated Poisson model
p-value: 0.02Zero-hurdle Poisson model
Primary

Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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.

Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMITreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up8.7 Number of treatment sessionsStandard Deviation 8.7
Arm 1 GMITreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up11.3 Number of treatment sessionsStandard Deviation 13.2
Arm 2 IHMDTreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up7.0 Number of treatment sessionsStandard Deviation 9.6
Arm 2 IHMDTreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up6.4 Number of treatment sessionsStandard Deviation 9.8
Arm 3 TCCTreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up8.8 Number of treatment sessionsStandard Deviation 9
Arm 3 TCCTreatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up8.3 Number of treatment sessionsStandard Deviation 11.1
p-value: <0.01Zero inflated Poisson model
p-value: <0.0001Zero-hurdle Poisson model
Secondary

Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

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).

Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days

Population: Intent to treat population (at least one GMI session attended)

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 GMINumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up0.74 Days of drug useStandard Deviation 1.6
Arm 1 GMINumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up0.9 Days of drug useStandard Deviation 2
Arm 2 IHMDNumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up0.62 Days of drug useStandard Deviation 2.3
Arm 2 IHMDNumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up0.51 Days of drug useStandard Deviation 1.6
Arm 3 TCCNumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysOne month follow up0.7 Days of drug useStandard Deviation 1.6
Arm 3 TCCNumber of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) DaysThree month follow up0.7 Days of drug useStandard Deviation 2
p-value: 0.17Zero inflated Poisson model
p-value: 0.67Zero-hurdle Poisson model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026