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

NCT04078360 | Completed

• 1 other identifier: MR/P020348/1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

1. 1.To assess the feasibility of delivering the mobile-based BI.
2. 2.To assess the acceptability of delivering the mobile-based BI.
3. 3.To inform sample size calculation (based on preliminary estimate of effectiveness) and refine procedures for a definitive RCT.
4. 4.To refine the mobile-based BI package for a definitive RCT.
5. 5.To assess the impact of the mobile-based BI, on treatment outcomes.

Conditions

Hazardous Drinking

Keywords

Hazardous Drinking, mHealth, India, Brief intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Mobile-based intervention (AMBIT)

EXPERIMENTAL

This arm will receive a mobile based program delivered over messages/IVR calls.

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

Face-to-face counselling

ACTIVE COMPARATOR

This arm will receive a brief counselling session from a trained health worker.

Behavioral: Face to face Brief Intervention

Active control

ACTIVE COMPARATOR

This arm will receive an educational BI leaflet.

Behavioral: BI leaflet intervention

Interventions

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

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

Mobile-based intervention (AMBIT)

Face to face Brief Intervention BEHAVIORAL

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).

Face-to-face counselling

BI leaflet intervention BEHAVIORAL

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

Active control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Males are included in all settings (educational institutions, workplaces and primary health centers) Females are included in colleges
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sangath: lead

Study Sites (1)

Goa Police

Panjim, Goa, India

Location

MeSH Terms

Interventions

Ethanol; Methods

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Abhijit Nadkarni, MBBS

  Sangath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a parallel three-arm single blind individually randomised controlled trial, with a nested qualitative study.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: September 17, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)