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. 2022 Sep 5;23(1):753.
doi: 10.1186/s13063-022-06673-3.

Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India-protocol for a two-arm randomized controlled trial

Priyanka Dhawan  1 , Sonu Goel  2 , Ashutosh Aggarwal  3 , Abhishek Ghosh  4 , Rajesh Vijayvergiya  5 , Bikash Medhi  6 , Dheeraj Khurana  7 , Roshan Verma  8
Affiliations

Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India-protocol for a two-arm randomized controlled trial

Priyanka Dhawan et al. Trials. .

Abstract

Background: To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its efficacy has not been established in hospital settings. The current study aims to investigate impact of trans-theoretical-based behavioral intervention package on tobacco users suffering from non-communicable diseases attending tertiary care settings of North India.

Methods/design: A two-arm randomized controlled trial (RCT) in a tertiary healthcare hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments, cardiology, neurology, pulmonary medicine, and ENT (otolaryngology), will be recruited over a period of 3 months. After ascertaining the eligibility criteria, they will be followed up to 6 months (1, 3, 6) for their tobacco use status, readiness to quit, nicotine dependence, stage of behavior change, and self-reported and biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, and blinding will be done as per SPIRIT guidelines for RCT protocols.

Discussion: As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, the current study will build evidence about the similar interventions in such settings.

Trial registration: CTRI/2019/09/021406.

Keywords: Behavioral therapy; Randomized controlled trial; Tertiary care setting; Tobacco cessation.

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Conflict of interest statement

The authors declares that they have no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow chart for enrolment and follow-up plan for randomized controlled trial
Fig. 2
Fig. 2
Steps of development and validation of intervention package
See this image and copyright information in PMC

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References

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