Back to resultsMobile Phone-Based Motivational Interviewing in Kenya
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-Person Motivational Interviewing (MI)
Mobile Motivational Interviewing (MI)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
In-Person Motivational Interviewing
Mobile MI
Waitlist Control
Arm Description
In-Person Motivational Interviewing (MI) is the standard form of MI treatment delivered in person face to face at the primary care office. MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping participants to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling in-person with the participant for one session of MI lasting approximately 30 minutes.
Mobile Motivational Interviewing (MI) is delivered by a counselor over the mobile phone, rather than in-person (face-to-face). MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping the patient to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling over the mobile phone with the participant for one session of mobile MI lasting approximately 30 minutes.
After consenting to participate in the study, the Waitlist control participants receive no intervention for one (1) month, and then the Waitlist control participants are contacted by the investigators for follow up..
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03573167
First Posted
June 1, 2018
Last Updated
June 18, 2018
Sponsor
University of Vermont
Collaborators
Africa Mental Health Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03573167
Brief Title
Mobile Phone-Based Motivational Interviewing in Kenya
Official Title
Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Africa Mental Health Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-Person Motivational Interviewing
Arm Type
Active Comparator
Arm Description
In-Person Motivational Interviewing (MI) is the standard form of MI treatment delivered in person face to face at the primary care office. MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping participants to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling in-person with the participant for one session of MI lasting approximately 30 minutes.
Arm Title
Mobile MI
Arm Type
Experimental
Arm Description
Mobile Motivational Interviewing (MI) is delivered by a counselor over the mobile phone, rather than in-person (face-to-face). MI is a type of brief intervention that uses open-ended questions, affirmations, reflective listening, and summarizing as key tools and has been shown to treat a range of problem behaviors, including alcohol use disorders, by helping the patient to identify and address ambivalence towards changing the behavior. MI is delivered in a communicative style that promotes individual autonomy and improves self-efficacy. The investigator provides counseling over the mobile phone with the participant for one session of mobile MI lasting approximately 30 minutes.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
After consenting to participate in the study, the Waitlist control participants receive no intervention for one (1) month, and then the Waitlist control participants are contacted by the investigators for follow up..
Intervention Type
Behavioral
Intervention Name(s)
In-Person Motivational Interviewing (MI)
Intervention Description
This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Motivational Interviewing (MI)
Intervention Description
This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant
Primary Outcome Measure Information:
Title
Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month.
Description
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.
Time Frame
1 month
Title
Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C from baseline to six (6) months.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Description
The investigators compared the change in AUDIT and AUDIT-C alcohol use scores over time moderated by HIV status.
Time Frame
1 and 6 months
Title
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.
Description
The investigators compared the change in AUDIT alcohol use scores over time moderated by ASEBA mental health diagnoses.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Harder, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Phone-Based Motivational Interviewing in Kenya
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