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

University of Manchester

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Behavioral: Volitional Help Sheets

Study type: Interventional

Funder types: Other

Identifiers

NCT05629039

VHS-Indonesia

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,700 participants in 10 patient groups

Wave 1-Experimental Group

Experimental group

Description:

The experimental group in Wave 1 will complete the baseline questionnaires (the socio-demographic, FTND, and COM-B questionnaires) followed by both the if-then list and the if-then link from the Volitional-Help Sheet as manipulations. The if-then list consists of several situations and solutions linked to smoking uptake in the volitional help sheet and the group will be informed that the activity will help to stop smoking. In addition, the if-then link consists of the situations in which people are urged to smoke and then link them to solutions that are most likely to help them abstain from starting smoking

Treatment:

Behavioral: Volitional Help Sheets

Wave 1-Control Group

No Intervention group

Description:

The control group participants will complete the baseline questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Wave 2-Control group

No Intervention group

Description:

This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Wave 2-Delayed VHS Group

Experimental group

Description:

This group will receive the (delayed) Volitional Help Sheets intervention after completing the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire).

Treatment:

Behavioral: Volitional Help Sheets

Wave 2-Early VHS Group

Experimental group

Description:

This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Treatment:

Behavioral: Volitional Help Sheets

Wave 2-Repeated VHS group

Experimental group

Description:

This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire), and receive a repeated, booster VHS intervention.

Treatment:

Behavioral: Volitional Help Sheets

Wave 3-Control Group

No Intervention group

Description:

This group will complete the six-month follow-up questionnaires. Due to ethical consideration, in wave three the control group will be offered the opportunity to complete the VHS form after they complete the follow-up assessments and the scores will not be included in the analysis.

Wave 3-Delayed VHS Group

Experimental group

Description:

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Treatment:

Behavioral: Volitional Help Sheets

Wave 3-Early VHS Group

Experimental group

Description:

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Treatment:

Behavioral: Volitional Help Sheets

Wave 3-Repeated VHS Group

Experimental group

Description:

This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention

Treatment:

Behavioral: Volitional Help Sheets