Alcohol Use Disorder Clinical Trial
Official title:
Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
Verified date | June 2018 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study was to test whether motivational interviewing (MI) provided over the mobile phone would reduce alcohol use among adults, including people living with HIV/AIDS, visiting primary care in Kenya. Heavy alcohol users voluntarily consented to being randomized to one of three study arms: standard in-person MI, mobile MI, or waitlist control receiving no intervention for 1 month followed by mobile MI. Alcohol use problems were assessed using validated screeners and changes in alcohol use were assessed at 1 month and 6 months after receiving the intervention. The investigators hypothesized that alcohol use would reduce after MI treatment compared to waitlist control, there would be no difference between standard in-person MI and mobile MI, and these reductions would be sustained out to six months following the intervention.
Status | Completed |
Enrollment | 322 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults visiting the primary care clinic and screening positive for potential alcohol use problems. Exclusion Criteria: - Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Vermont | Africa Mental Health Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month. | The investigators compared the change in AUDIT-C alcohol use score from baseline to one (1) month after the intervention between the investigators' three study arms. | 1 month | |
Primary | Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C from baseline to six (6) months. | The investigators compared the change in AUDIT and AUDIT-C alcohol use scores from baseline to six (6) months after the intervention between the investigators' two active study arms: 1) In-Person Motivational Interviewing (MI) and 2) Mobile MI. | 6 months | |
Secondary | Reduction in alcohol use score as measured by the AUDIT and AUDIT-C moderated by HIV co-morbidity from baseline to one (1) month and from baseline to six (6) months. | The investigators compared the change in AUDIT and AUDIT-C alcohol use scores over time moderated by HIV status. | 1 and 6 months | |
Secondary | Reduction in alcohol use score as measured by the AUDIT moderated by mental health co-morbidity, as measured by the Achenbach System of Empirically Based Assessments (ASEBA) Adults Self-Report, from baseline to six (6) months. | The investigators compared the change in AUDIT alcohol use scores over time moderated by ASEBA mental health diagnoses. | 6 months |
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