Alcohol Use Disorders- Mobile Based Brief Intervention Treatment (AMBIT) Technology Innovation to Bridge the Treatment Gap for Hazardous Drinking: A Pilot RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change in Time Line Follow Back (TLFB) measure of frequency of drinking- Percent Days Abstinent (PDA).
Study Overview
Brief Summary
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
- To assess the feasibility of delivering the mobile-based BI.
- To assess the acceptability of delivering the mobile-based BI.
- To inform sample size calculation (based on preliminary estimate of effectiveness) and refine procedures for a definitive RCT.
- To refine the mobile-based BI package for a definitive RCT.
- To assess the impact of the mobile-based BI, on treatment outcomes.
Detailed Description
The AMBIT study is aimed at developing and evaluating a mobile based BI for hazardous drinkers in Goa-India. The first version of the treatment package was developed through formative research, and tested through a case series, to develop the final intervention. This pilot Randomised Control Trial (RCT) will aim to empirically evaluate the feasibility, acceptability and preliminary impact of the BI, and fine-tune the procedures for a definitive RCT. This protocol will serve as a research framework for the implementation of the proposed pilot RCT.
OBJECTIVES
- To assess the feasibility of delivering the mobile-based BI.
- To assess the acceptability of delivering the mobile-based BI.
- To inform sample size calculation (based on preliminary estimate of effectiveness) and refine procedures for a definitive RCT.
- To refine the mobile-based BI package for a definitive RCT.
- To assess the impact of the mobile-based BI, on treatment outcomes. METHODS Study sample- A sample of 120 participants will be recruited; approximately evenly spread out across all study settings and interventions. The sample size is not based on formal power calculations as the study is not designed to test a hypothesis. The sample size estimations have been made based on our previous experiences of pilot RCTs and deemed sufficient to achieve the goals of understanding the acceptability, feasibility, and preliminary impact of an intervention.
Recruitment Procedure- In all three settings, researchers, who will identify hazardous drinkers through appropriate screening procedures. Eligible participants will be invited to join the study if they provide voluntary consent to participate.
In educational institutions and workplaces: At educational institutions and workplaces participant recruitment will be nested within the health and wellness camp (previously tested during the formative research phase), that includes screening for two other health-related issues (Perceived Stress and Physical Activity) aside from AUD screening. This is done to overcome resistance to entering screening for an alcohol-related program, due to cultural stigma around alcohol consumption. It is expected that by introducing screening for a range of health issues, this issue will be mitigated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The PI and outcomes assessor will be masked. The screeners will recruit participants into the study, who will then be randomised to one of the three arms of the study. The data team will then assign a masked outcome assessor to collect outcome data.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Mobile-based intervention (AMBIT)
This arm will receive a mobile based program delivered over messages/IVR calls.
Intervention: AMBIT (Alcohol use disorders- mobile based Brief Intervention treatment) intervention (Behavioral)
Face-to-face counselling
This arm will receive a brief counselling session from a trained health worker.
Intervention: Face to face Brief Intervention (Behavioral)
Active control
This arm will receive an educational BI leaflet.
Intervention: BI leaflet intervention (Behavioral)
Outcomes
Primary Outcomes
Change in Time Line Follow Back (TLFB) measure of frequency of drinking- Percent Days Abstinent (PDA).
Time Frame: At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement
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.
Secondary Outcomes
- Change in Time Line Follow Back measure of quantity of drinking- gms ethanol/week.(At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement)
- Change in Time Line Follow Back measure of patterns of drinking-Percent Days Heavy Drinking (PDHD).(At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement)
- Change in Time Line Follow Back measure of intensity of drinking-gms ethanol per drinking day.(At baseline and at 3 months post-randomisation in all participants regardless of treatment engagement)
Investigators
Abhijit Nadkarni
Associate Professor
London School of Hygiene and Tropical Medicine