Hazardous Drinking Clinical Trial
— AMBITOfficial title:
Alcohol Use Disorders- Mobile Based Brief Intervention Treatment (AMBIT) Technology Innovation to Bridge the Treatment Gap for Hazardous Drinking: A Pilot RCT
Verified date | July 2020 |
Source | Sangath |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The World Health Organization (WHO) defines three levels of problematic alcohol use;
hazardous drinking (HD) (which puts a person at risk of developing health/social problems),
harmful drinking (where health/social problems are already occurring), and alcohol dependence
(where serious problems have already occurred). Although HD and harmful drinking affects a
larger proportion of the population (and causes many more problems) than alcohol dependence,
Indian health policy focuses mainly on institutional delivery of care for alcohol dependence.
Extensive evidence globally demonstrates the effectiveness of Brief Interventions (BIs) in
reducing drinking in HD. However, in India, barriers to providing such treatments are the
inequitable distribution of trained healthcare professionals and concerns about the cultural
generalisability of interventions developed in the West. Mobile phone technology like SMS
(Short Messaging Service) and interactive voice response (IVR) can deliver BIs to large
numbers of HDs, quickly and at low cost, as demonstrated in smoking cessation interventions.
Furthermore, a growing body of evidence demonstrates that following a systematic methodology
to culturally adapt psychosocial interventions increases acceptability by recipients and
delivery agents, and feasibility of delivery. The overall objective of AMBIT is to develop a
contextually appropriate BI for HD that can be delivered using mobile phone technology to
overcome barriers to access in low resource settings.
Preliminary formative research has informed the development of the first version of the
treatment package, which was tested through a case series, by refining the intervention
content and delivery through an iterative process, to develop the final intervention. This
pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility and
acceptability, as well as preliminary impact of the BI, and fine-tune the procedures for a
definitive RCT. It therefore does not have clear hypotheses, but instead different primary
objectives, which are listed in the following.
OBJECTIVES
1. To assess the feasibility of delivering the mobile-based BI.
2. To assess the acceptability of delivering the mobile-based BI.
3. To inform sample size calculation (based on preliminary estimate of effectiveness) and
refine procedures for a definitive RCT.
4. To refine the mobile-based BI package for a definitive RCT.
5. To assess the impact of the mobile-based BI, on treatment outcomes.
Status | Completed |
Enrollment | 74 |
Est. completion date | June 15, 2020 |
Est. primary completion date | June 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: - Hazardous drinkers (Alcohol Use Disorder Identification Test [AUDIT] score = 8-15). AUDIT is a 10-item screening questionnaire developed by the WHO for the detection of alcohol use disorders (Saunders et al., 1993). - Adult (>18 years) males and females in educational institutions - Males aged 18-65 years in workplaces and primary health centres - Personal ownership of a mobile phone and is SMS/IVR call savvy. Exclusion criteria: - Females (In workplaces and primary health centers) - Participants owning a shared/family phone - Aged <18 years and >65 years - Owns a mobile phone but is not SMS/IVR call savvy - Harmful and dependent drinkers (AUDIT score >15) |
Country | Name | City | State |
---|---|---|---|
India | Goa Police | Panjim | Goa |
Lead Sponsor | Collaborator |
---|---|
Sangath |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Time Line Follow Back (TLFB) measure of frequency of drinking- Percent Days Abstinent (PDA). | TLFB (Time Line Follow Back method): The TLFB is a calendar method of collecting data about quantity and frequency of drinking and various memory aids are used to enhance recall (e.g. special dates).. The TLFB has high test-retest reliability and concurrent validity has been established in various types of AUD. The TLFB has been used in previous research at the study site (Nadkarni, 2017) Percent Days Abstinent reflects on which percentage of 14 days prior to assessment a participant has not drunk any alcohol. | At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement | |
Secondary | Change in Time Line Follow Back measure of quantity of drinking- gms ethanol/week. | Gms ethanol/week: Amount of ethanol consumed per week as measured via Time Line Follow Back method. | At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement | |
Secondary | Change in Time Line Follow Back measure of patterns of drinking-Percent Days Heavy Drinking (PDHD). | Percent Days Heavy Drinking: The percentage of days measured via TLFB on which the participant drank heavily (defined as at least 6 drinks per day). | At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement | |
Secondary | Change in Time Line Follow Back measure of intensity of drinking-gms ethanol per drinking day. | Intensity of drinking - gms ethanol per drinking day: The average amount of ethanol consumed by a participant on drinking days over the 14 days timeframe measured via the TLFB. | At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement |
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