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

NCT ID: NCT05629039

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wave 1-Experimental Group

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

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 1-Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Wave 2-Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Wave 2-Delayed VHS Group

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).

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 2-Early VHS Group

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

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 2-Repeated VHS group

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.

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 3-Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Wave 3-Delayed VHS Group

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

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 3-Early VHS Group

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

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Wave 3-Repeated VHS Group

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

Group Type EXPERIMENTAL

Volitional Help Sheets

Intervention Type 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.

Interventions

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Volitional Help Sheets

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Volitional help sheets for smoking cessation

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Rina Rahmatika

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Armitage

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Tim Millar

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Rina Rahmatika

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rahmatika

Role: CONTACT

+447460250940

Facility Contacts

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Rina Rahmatika

Role: primary

Other Identifiers

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VHS-Indonesia

Identifier Type: -

Identifier Source: org_study_id

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