Evidence map›Paper›PMID 37315070›Full record

ArticlePloS one2023

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 and 8 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Papiya MazumdarDepartment of Health Sciences, University of York, York, United Kingdom.ORCID 0000-0002-3197-4698
Gerardo ZavalaDepartment of Health Sciences, University of York, York, United Kingdom.ORCID 0000-0002-9825-8725
Faiza AslamInstitute of Psychiatry, Rawalpindi, Pakistan.
Krishna Prasad MuliyalaNational Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.
Santosh Kumar ChaturvediNational Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.
Arun KandasamyNational Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.
Asad NizamiInstitute of Psychiatry, Rawalpindi, Pakistan.
Baha Ul HaqInstitute of Psychiatry, Rawalpindi, Pakistan.
Ian KellarSchool of Psychology, University of Leeds, Leeds, United Kingdom.ORCID 0000-0003-1608-5216
Cath JacksonDepartment of Health Sciences, University of York, York, United Kingdom.
Heather ThomsonAdults and Health, Leeds City Council, United Kingdom.
David McDaidCare Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
Kamran SiddiqiDepartment of Health Sciences, University of York, York, United Kingdom.
Catherine HewittDepartment of Health Sciences, University of York, York, United Kingdom.
Najma SiddiqiDepartment of Health Sciences, University of York, York, United Kingdom.
Simon GilbodyDepartment of Health Sciences, University of York, York, United Kingdom.
Pratima MurthyNational Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.
Noreen Dadirai MdegeDepartment of Health Sciences, University of York, York, United Kingdom.ORCID 0000-0003-3189-3473

Funding

Department of Health 17/63/130
6 · The paper itself

Abstract

introductionThe 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.

methodsWe 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.

resultsStudy 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.

conclusionsThis 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 registrationISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.

Indexed as

Smoking CessationAdultAsia, SouthernBehavior TherapyFeasibility StudiesHumansRandomized Controlled Trials as TopicSmoking

Identifiers

PMID37315070
PMCPMC10266604

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.