About this trial
Gender and sexual minority adults in Bangladesh experience high levels of stigma-related stress. Acute stress can trigger strong, affect-driven urges to smoke, vape, or engage in stress-attributed eating. These urges can rise and fall within minutes to hours, operating outside the reach of conventional clinic-based interventions delivered days or weeks later.
This pilot micro-randomized trial (MRT) evaluates whether delivering a brief, culturally adapted support message via smartphone during moments of high self-reported stress reduces the intensity of the urge for the participant's pre-specified target behaviour, relative to no message. Over a 24-day period, 115 participants will be scheduled for up to 5 ecological momentary assessments (EMA) per day. Whenever a participant reports an acute stress level of 5 or higher (0 to 10 scale) and satisfies pre-specified privacy, safety, behavioural, and spacing criteria, the app randomizes with probability 0.5 to deliver either a brief support message or no message. By contributing multiple randomized decision points over time, each participant serves as their own micro-control.
The primary outcome is the intensity of the urge for the participant's pre-specified target behaviour, measured 45 to 60 minutes after randomization. An exploratory urge assessment is also collected 10 minutes after randomization; comparing the two time points will help establish whether the support message's effect is immediate, delayed, or both, and will inform the choice of follow-up window for a future, fully powered trial. Prior to trial launch, all EMA items, message content, notification logic, and digital safety protocols will be developed and tested with community members, reviewed by a Community Advisory Board, and locked.
As a pilot optimization trial, its objectives are to estimate the short-term causal effect of the prompt, to identify the contexts in which that effect is larger or smaller, and to establish whether momentary assessment and just-in-time intervention research can be delivered safely, privately, and acceptably in this high-stigma setting. The study does not evaluate long-term behavioural maintenance and does not claim to address the underlying structural stigma and discrimination that produce minority stress.
Eligibility criteria
Qualifiers
Age 18 years or older
Self-identifies as a gender and/or sexual minority person
Resides in Dhaka at enrolment and expects to remain in Dhaka throughout the 24-day assessment period
Reports at least one qualifying behaviour on average at least 3 days per week during the past month: (a) smoking or vaping, or (b) eating primarily in response to stress, anxiety, or emotional distress
Disqualifiers
Currently participating in another behavioural or pharmacological intervention study targeting smoking, vaping, or eating behaviour
Has a severe or unstable psychiatric condition that, based on screening and review by the study clinician, would make participation in the repeated daily assessment protocol unsafe
Is unable to operate the study app independently after structured onboarding
Trial design
Treatments tested in this trial
- Just-in-Time Adaptive Support Message
Treatment groups
Sponsors and collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Global Affairs Canada
Collaborator