Efficacy of yoga-breath linked intervention to stop smoking (Y-BLISS) in reducing the number of cigarettes smoked per day among smokers attempting to reduce or quit: Study protocol for a randomized controlled trial.

The proposed research aims to test the effects of a two-month yoga-breath linked intervention to stop smoking (Y-BLISS) as an add-on to standard treatment in tobacco use disorder (TUD; in the form of cigarette smoking) by conducting a randomized controlled study with the following primary outcome variable: number of cigarettes smoked per day. Secondary outcome variables are motivation to stop smoking, craving, dependence severity, lung capacity, and exhaled carbon-monoxide, and 7-day point-prevalence abstinence (7PPA). In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 100 patients with TUD availing the outpatient/inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (Y-bliss arm), or desktop exercise arm (D-exercise arm). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized 12-minute yoga program (Y-BLISS) for TUD will be used as an intervention. The control group will receive an equivalent 12-minute desktop exercise module. Participants in respective arms will receive 40 online supervised sessions over 8 weeks, 5 sessions per week in the mornings as they will be asked to practice the same on an as-neededs basis whenever they feel cravings for cigarette smoking. Assessments will be done at baseline, 4th week and 8 th week. Data from all randomized subjects will be analyzed using intent-to-treat analysis and mixed model multivariate analysis. Dissemination Findings will be disseminated through peer-reviewed publications, conference presentations, and social media. Trial registration number The trial has been registered under Clinical Trials Registry India (CTRI) with the registration number: CTRI/2022/12/048117, date of registration: 14 th December 2022.