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Trial record 2 of 2 for:    23497788 [PUBMED-IDS]

Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans (GMI-IHMDs)

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ClinicalTrials.gov Identifier: NCT00706901
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : February 4, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcohol Dependence
Dual Diagnosis
Drug Dependence
Interventions Behavioral: Arm 1 GMI
Behavioral: Arm 2 IHMD
Behavioral: Arm 3 TCC
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 59 62 59
Completed 51 57 51
Not Completed 8 5 8
Reason Not Completed
Lost to Follow-up             2             3             2
Withdrawal by Subject             4             2             5
In Jail             1             0             1
Death             1             0             0
Arm/Group Title Arm 1 GMI Arm 2 IHMD Arm 3 TCC Total
Hide Arm/Group Description Group Motivational Interviewing In-Home-Messaging Device Treatment Control condition Total of all reporting groups
Overall Number of Baseline Participants 59 62 59 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 62 participants 59 participants 180 participants
52.9  (8.8) 52.3  (10.3) 51.1  (10.6) 52.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 62 participants 59 participants 180 participants
Female
5
   8.5%
4
   6.5%
5
   8.5%
14
   7.8%
Male
54
  91.5%
58
  93.5%
54
  91.5%
166
  92.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 62 participants 59 participants 180 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
32
  54.2%
36
  58.1%
36
  61.0%
104
  57.8%
White
27
  45.8%
25
  40.3%
22
  37.3%
74
  41.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.6%
1
   1.7%
2
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 62 participants 59 participants 180 participants
59 62 59 180
1.Primary Outcome
Title Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In Home Messaging Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Days Using Alcohol
One month follow up 5.1  (7.6) 6.5  (9.5) 6.7  (10.3)
Three month follow up 8.8  (13.3) 10.9  (16.3) 9.9  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Zero inflated Poisson model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 IHMD, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method zero-hurdle Poisson model
Comments [Not Specified]
2.Primary Outcome
Title Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 (IHMD) Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In-Home-Messaging-Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Days of binge drinking
One month follow up 3.1  (6.5) 2.7  (6.5) 6.1  (10.5)
Three month follow up 5.1  (10.8) 4.0  (10.5) 7.9  (17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Zero inflated Poisson model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 (IHMD), Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value .0002
Comments [Not Specified]
Method Zero-hurdle Poisson model
Comments [Not Specified]
3.Primary Outcome
Title Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 (IHMD) Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In-Home-Messaging-Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Standard alcohol drinks
One month follow up 45.1  (98.1) 45.8  (100.7) 70.0  (131.1)
Three month follow up 66.5  (156.6) 64.6  (129.7) 112.3  (251.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Weibull mixture model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 (IHMD), Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Primary Outcome
Title Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 (IHMD) Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In-Home-Messaging-Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Number of treatment sessions
One month follow up 8.7  (8.7) 7.0  (9.6) 8.8  (9.0)
Three month follow up 11.3  (13.2) 6.4  (9.8) 8.3  (11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Zero inflated Poisson model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 (IHMD), Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Zero-hurdle Poisson model
Comments [Not Specified]
5.Primary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 (IHMD) Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In-Home-Messaging-Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Number of 12-step sessions attended
One month follow up 8.0  (12.0) 5.1  (8.8) 7.1  (29.6)
Three month follow up 16.2  (22.4) 10.6  (16.6) 16.2  (22.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Zero inflated Poisson model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 (IHMD), Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Zero-hurdle Poisson model
Comments [Not Specified]
6.Secondary Outcome
Title Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (at least one GMI session attended)
Arm/Group Title Arm 1 GMI Arm 2 (IHMD) Arm 3 TCC
Hide Arm/Group Description:
Group Motivational Interviewing
In-Home-Messaging-Device
Treatment Control Condition
Overall Number of Participants Analyzed 59 62 59
Mean (Standard Deviation)
Unit of Measure: Days of drug use
One month follow up 0.74  (1.6) 0.62  (2.3) 0.7  (1.6)
Three month follow up 0.9  (2.0) 0.51  (1.6) 0.7  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 GMI, Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Zero inflated Poisson model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2 (IHMD), Arm 3 TCC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Zero-hurdle Poisson model
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Hide Arm/Group Description Group Motivational Interviewing In Home Messaging Device Treatment Control Condition
All-Cause Mortality
Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/59 (3.39%)      0/62 (0.00%)      0/59 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death due to throat cancer * [1]  1/59 (1.69%)  59 0/62 (0.00%)  0 0/59 (0.00%)  0
Psychiatric disorders       
Suicidal Ideation * [2]  1/59 (1.69%)  59 0/62 (0.00%)  0 0/59 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Participant had throat cancer and died during follow up
[2]
A participant indicated positively that he was experiencing suicidal ideation. Participant was evaluated by a VA psychiatrist who determined that the patient should be hospitalized for stabilization. This was reported to the IRB.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 GMI Arm 2 IHMD Arm 3 TCC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth Santa Ana, Ph.D.
Organization: Charleston VAMC
Phone: (843) 789-7168
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00706901     History of Changes
Other Study ID Numbers: CDA-2-016-08S
IIR 13-317-2 ( Other Grant/Funding Number: Clinical Science Research and Development )
First Submitted: June 26, 2008
First Posted: June 30, 2008
Results First Submitted: October 30, 2014
Results First Posted: February 4, 2015
Last Update Posted: August 8, 2018