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

Papiya Mazumdar, Gerardo Zavala, Faiza Aslam, Krishna Prasad Muliyala, Santosh Kumar Chaturvedi, Arun Kandasamy, Asad Nizami, Baha Ul Haq, Ian Kellar, Cath Jackson, Heather Thomson, David McDaid, Kamran Siddiqi, Catherine Hewitt, Najma Siddiqi, Simon Gilbody, Pratima Murthy, Noreen Dadirai Mdege

Research output: Contribution to journalArticlepeer-review

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 smoking cessation support for people with severe mental illness in South Asia (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 (BA) 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 upto 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. 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. We will also conduct a process evaluation.

RESULTS: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries.

CONCLUSIONS: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums.

TRIAL REGISTRATION: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.

Original languageEnglish
Article numbere0287185
Number of pages18
JournalPLOS ONE
Volume18
Issue number6
DOIs
Publication statusPublished - 14 Jun 2023

Bibliographical note

© 2023 Mazumdar et al.

Keywords

  • Adult
  • Humans
  • Smoking Cessation
  • Asia, Southern
  • Feasibility Studies
  • Smoking
  • Behavior Therapy
  • Randomized Controlled Trials as Topic

Cite this