Alcohol Use Disorders- Mobile Based Brief Intervention Treatment (AMBIT): A Pilot RCT

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

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.

Conditions

• Hazardous Drinking

Interventions

BEHAVIORAL

AMBIT (Alcohol use disorders- mobile based Brief Intervention treatment) intervention

The intervention will consist of participants receiving messages and/IVR calls not more than twice or thrice a week on their mobile phone for a duration of 8 weeks. Messages/IVR calls will be sent through VIAMO's technology platform. Each week messages will be focussed on specific content areas derived from the formative research of the study. Some of the components of the intervention include: 1. Self awareness messages 2. Self reflection messages 3. Motivational messages 4. Messages on safe drinking, alcohol reduction, drinking management, risk management, craving management and drinking alternatives. 5. Health education messages 6. Personalized feedback and information 7. Help-seeking resources 8. Goal setting messages

BEHAVIORAL

Face to face Brief Intervention

The intervention will consist of the participants receiving the BI based on the WHO Mental Health Gap Action Programme (mhGAP) intervention from a trained researcher. The BI will be conducted over a single session (5-10 mins).

BEHAVIORAL

BI leaflet intervention

The intervention will consist of an educational BI leaflet consisting of health information on alcohol consumption, and tips to manage and reduce drinking.

Sponsors & Collaborators

• Sangath

  lead OTHER

Principal Investigators

• Abhijit Nadkarni, MBBS · Sangath

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-17

Primary Completion

2020-06-15

Completion

2020-06-15

Countries

• India

Study Locations