Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00706901
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2008-06-26
Brief Title:
Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GMI-IHMDs
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 individuals 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 eg 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 ie number of all substance abuse outpatient other mental health eg PTSD depression and other substance abuse treatment sessions and self-reported 12-step number of self-help AANA sessions including days consulting with a 12-step or mutual self-help sponsor Exploratory outcomes measures include number of illicit drug use days eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIR 13-317-2 | OTHER_GRANT | Clinical Science Research and Development | None |