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Completed

NCT Number: NCT05629039

Implementing an Intervention Named Volitional Help Sheets to Reduce Smoking Behaviour Among Young Adults in Indonesia

Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rina Rahmatika

Manchester, M13 9PL, United Kingdom

About this study

The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Smokers whose ages are 20-45 years old

Exclusion criteria

  • Non-smokers whose ages are below 20 years old and above 45 years old

Treatment and study plan

Volitional Help Sheets

Behavioral

The volitional help sheet is an intervention which provides an opportunity for people to actively plan their behavioural changes by using a list of situations and solutions. The list of situations are critical situations which provoke unwanted behaviour, and the solutions are the responses to overcome the situations which urge the unexpected behaviour. In the context of smoking behaviour, the list of situations is the situations that will provoke cigarette uptake and the list of solutions is the appropriate responses to reduce or stop the urge to smoke.

Other names: Volitional help sheets for smoking cessation

Primary outcomes

  1. Smoking Cessation

    Time frame: 6 months

    Participants will complete a self-report questionnaire to assess their cigarette uptake by ticking one of the following options: (a) I have never smoked (b) I have only tried smoking once (c) I used to smoke sometimes, but I never smoke cigarettes now (d) I sometimes smoke cigarettes now, but I do not smoke as many as one a week (e) I usually smoke between one and six cigarettes a week (f) I usually smoke more than six cigarettes a week. The code for the response of options "a-d" is 0, and "e-f" is 1.

Secondary outcomes

  1. Nicotine dependence

    Time frame: 6 months

    The Fagerstrom nicotine dependence scale will assess nicotine dependence. The scoring method in FTND is 0 to 1 for yes/no items and a score of 0 to 3 for the multiple-choice items. The items are summed to yield a total score of 0-10. The higher the total FTND score, the more intense the smoker's physical dependence on nicotine.

  2. Intervention evaluation

    Time frame: 6 months

    The Capability Opportunity Motivation-Behaviour (COM-B) Questionnaire will measure how the intervention contributes to the behaviour changes. The higher the score, the more the intervention contributes to the behaviour changes.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Volitional Help Sheet to Promote Smoking Cessation Among Young Adults in Indonesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 29, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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