Alcohol Use DisorderNCT03573167
Mobile Phone-Based Motivational Interviewing in Kenya
A study testing In-Person Motivational Interviewing (MI) and Mobile Motivational Interviewing (MI) in people with Alcohol Use Disorder, run by University of Vermont.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- In-Person Motivational Interviewing (MI) and Mobile Motivational Interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2014to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults visiting the primary care clinic and screening positive for potential alcohol use problems.
Who cannot join
- Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study
About this study
Official title: Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- In-Person Motivational Interviewing (MI), Mobile Motivational Interviewing (MI)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Motivational Interviewing (MI)Behavioural
This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.
Mobile Motivational Interviewing (MI)Behavioural
This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant
| Study group | Role | What they receive |
|---|---|---|
| In-Person Motivational Interviewing | Active comparator | 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. Receives: Behavioral: In-Person Motivational Interviewing (MI) |
| Mobile MI | Experimental | 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. Receives: Behavioral: Mobile Motivational Interviewing (MI) |
| Waitlist Control | No intervention | 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.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 1 and 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start30 Sep 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Responsible party
- Principal investigator, Valerie Harder, University of Vermont
- Investigators
- Valerie Harder, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573167
- Sponsor's protocol ID
- CHRBSS 14-188
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
- ClinicalTrials.gov ID
- NCT03573167
- Acronym / sponsor ID
- CHRBSS 14-188
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person Motivational Interviewing | Active comparator | Behavioral: In-Person Motivational Interviewing (MI)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 MI | Experimental | Behavioral: Mobile Motivational Interviewing (MI)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. |
| Waitlist Control | No intervention | –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.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults visiting the primary care clinic and screening positive for potential alcohol use problems.
Key exclusion criteria (1 listed)
- Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Motivational Interviewing (MI)This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant. | Behavioural | In-Person Motivational Interviewing |
| Mobile Motivational Interviewing (MI)This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant | Behavioural | Mobile MI |
Primary outcome
Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
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.
Time frame: 1 and 6 months
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.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Harder, PhD principal investigator
University of Vermont
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Motivational Interviewing (MI) and Mobile Motivational Interviewing (MI) in people with Alcohol Use Disorder, run by University of Vermont.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.