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.
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
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
Single group
Just-in-Time Adaptive Support Message
BehavioralA brief, culturally adapted, in-app behavioral support message delivered on the participant's own smartphone immediately after randomization at an eligible high-stress decision point. Content is finalized and locked before the trial following a formative cultural adaptation phase and review by a Community Advisory Board. The message is matched to the participant's locked target behavior and may include grounding, urge-delay, motivational, values-based, environmental, substitute-action, social-support, or location-change strategies. It is nonjudgmental, action-oriented, designed to be read in under one minute, and requires no immediate response. At decision points randomized to the no-message option, no immediate support message is delivered.
Target-behavior momentary urge intensity
Self-reported current urge intensity for the participant's locked target behavior, rated on an 11-point numeric rating scale from 0 to 10. For participants targeting smoking or vaping, the outcome is the urge to smoke or vape. For participants targeting stress-attributed eating, the outcome is the urge to eat in response to stress or emotional distress. Only the rating corresponding to the participant's locked target behavior contributes to the primary outcome. Scores are not combined into a within-assessment composite. A score of 0 indicates no urge at all and 10 indicates the strongest urge imaginable; higher scores indicate a worse outcome.
Smoking or vaping episode following randomization
Among participants whose locked target behavior is smoking or vaping, binary self-report of whether any smoking or vaping occurred between the randomized decision point and the follow-up assessment. Coded 0 for no and 1 for yes; a higher occurrence rate indicates a worse outcome.
Stress-attributed eating episode following randomization
Among participants whose locked target behavior is stress-attributed eating, binary self-report of whether the participant ate primarily because of stress or emotional discomfort between the randomized decision point and the follow-up assessment. Eating primarily because of hunger, social context, food availability, or another non-emotional reason is not counted. Coded 0 for no and 1 for yes; a higher occurrence rate indicates a worse outcome.
Momentary assessment completion rate
Percentage of momentary assessments completed within the allowed response window, calculated overall and per participant. The denominator will include assessments delivered and available for completion and will exclude assessments automatically suppressed by the protocol because they fell within 60 minutes after a randomization. Pre-specified progression thresholds: 70 per cent or above proceed; 50 to 69 per cent proceed with protocol amendment; below 50 per cent do not proceed to a future trial without redesign.
Participant retention through day 24
Percentage of enrolled participants who complete the full 24-day assessment period, and the mean number of days contributed per participant. Pre-specified progression threshold: attrition of 15 per cent or less proceed; 16 to 30 per cent proceed with amendment; above 30 per cent redesign before a future trial.
Target-behavior urge intensity at the 10-minute micro-check
Exploratory self-reported current urge intensity for the participant's locked target behavior, rated from 0 to 10 using the same behavior-specific item and anchors as the primary outcome. Higher scores indicate a stronger urge and a worse outcome. This measure will be used to estimate the early proximal effect of the support message and will not be treated as a primary endpoint.
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Global Affairs Canada
Collaborator
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