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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 : Active, not recruiting
First Posted : June 30, 2008
Results First Posted : February 4, 2015
Last Update Posted : February 28, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Arm 1 GMI   Arm 2 IHMD   Arm 3 TCC
STARTED   59   62   59 
COMPLETED   51   57   51 
NOT COMPLETED   8   5   8 
Lost to Follow-up                2                3                2 
Withdrawal by Subject                4                2                5 
In Jail                1                0                1 
Death                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 GMI Group Motivational Interviewing
Arm 2 IHMD In-Home-Messaging Device
Arm 3 TCC Treatment Control condition
Total Total of all reporting groups

Baseline Measures
   Arm 1 GMI   Arm 2 IHMD   Arm 3 TCC   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   62   59   180 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.9  (8.8)   52.3  (10.3)   51.1  (10.6)   52.1  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   59   62   59   180 


  Outcome Measures

1.  Primary:   Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days   [ 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 ]

2.  Primary:   Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days   [ Time Frame: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days ]

3.  Primary:   Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days   [ Time Frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days ]

4.  Primary:   Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days   [ Time Frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days ]

5.  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   [ Time Frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days ]

6.  Secondary:   Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days   [ Time Frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: elizabeth.santaana2@va.gov


Publications of Results:

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: February 28, 2018