IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S): a protocol for a randomised controlled feasibility trial of a combined behavioural and pharmacological support intervention

Publication Summary

Abstract Introduction: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention (i.e., the IMPACT 4S intervention) that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. Methods: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in up to 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. The outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. A process evaluation will also be conducted. Ethics and dissemination: The study has been approved by the University of York Health Sciences Research Governance Committee; Health Ministry Screening Committee, India; the Ethics Committee (Behavioural Sciences Division), NIMHANS, Bangalore, India; National Bioethics Committee Pakistan and; Institutional Research and Ethics Forum of Rawalpindi Medical University, Pakistan. Feasibility study results will be disseminated through peer-review articles, and presentations at national and international conferences and policy-engagement forums.