Measuring the effects of adapting a digital alcohol intervention to individuals' motives for drinking and their readiness to change
| ISRCTN | ISRCTN87600318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87600318 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1.0, 2022-00193 |
| Sponsor | Linköping University |
| Funder | Forskningsrådet om Hälsa, Arbetsliv och Välfärd |
- Submission date
- 12/06/2024
- Registration date
- 12/06/2024
- Last edited
- 14/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Alcohol consumption continues to be a leading cause of disease in Sweden. More than 40% of the Swedish population drinks at levels that significantly increase the risk of negative consequences. Digital interventions could help people to reduce their drinking. This study explores if a digital intervention's effectiveness can be improved by adapting it to the individuals' motives for drinking and their readiness to change.
Who can participate?
People aged 18 years or older who have a Swedish mobile phone and who drink above Swedish guidelines
What does the study involve?
Some participants will be given access to a digital alcohol intervention which involves receiving text message prompts every Sunday to monitor drinking and receive feedback and advice. Other participants will receive referrals to national information sources. All participants will be asked to complete digital questionnaires on their mobile phones.
What are the potential benefits and risks of participating?
Support will be provided that may help participants to reduce their drinking. The interventions will not be effective for everyone, so participating in the study may lead to disappointment due to not changing behaviour.
Where is the study run from?
Linköping University (Sweden)
When is the study starting and how long is it expected to run for?
January 2023 to October 2026
Who is funding the study?
Swedish Research Council for Health, Working Life, and Welfare (Sweden)
Who is the main contact?
Dr Marcus Bendtsen, marcus.bendtsen@liu.se
Contact information
Public, Scientific, Principal investigator
Linköping University
Linköping
581 83
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|---|
| Phone | +46 (0)13-28 10 00 |
| marcus.bendtsen@liu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-arm (1:1:1) parallel-group randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effects of a drinking motives and readiness to change adapted digital alcohol intervention among online help-seekers |
| Study acronym | TOPHAT-5 |
| Study objectives | The primary aim of the study is to estimate the effects of an individual personalised (adapted) digital alcohol intervention. The adapted intervention will be contrasted against two comparators: (1) an existing digital alcohol intervention which is not personalised (non-adapted), which has previously been found to be effective; and (2) referral to online resources that would typically be found when looking online. The secondary aims of the study include estimating the degree to which the effects of the interventions are mediated through mechanisms of behaviour change and estimating individual-level effects. User evaluation and analyses of engagement in the intervention materials will also be part of the study. |
| Ethics approval(s) |
Approved 16/04/2024, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2024-01630-01 |
| Health condition(s) or problem(s) studied | Behaviour change support for individuals who want to reduce their alcohol consumption |
| Intervention | Current interventions as of 26/02/2025: Block randomisation with random block sizes of 3 and 6 to three arms (1:1:1). All randomisation procedures will be computerised. Non-adapted intervention: The non-adapted intervention will be delivered to participants via their mobile phones as a toolbox with six modules to manipulate these critical health-determining factors. The content of these modules is anchored in state-of-the-art empirical evidence for which active ingredients are effective for supporting reduced alcohol consumption, including behaviour substitution, problem-solving, goal setting, review of behavioural goals, self-monitoring, normative feedback, and understanding the consequences of alcohol consumption. The core element of the intervention is a text message sent to participants each Sunday afternoon. The message includes a prompt to self-monitor one’s current alcohol consumption and a link to a web-based screening tool. The screening tool assesses the past week's consumption, and participants are subsequently given access to the toolbox with six modules. In brief, these modules consist of: 1. Normative feedback on the past week’s consumption based on age and sex. 2. Information about some of the risks of drinking alcohol, including the risk of disease, how it may affect children in proximity, injuries, and traffic accidents. 3. A goal-setting tool with feedback on previously set goals and a timeline showing consumption over time. 4. Tips and teaching of skills which participants can use in their everyday life to immediately reduce their drinking, including tasks designed to make participants reflect on their behaviour. 5. Text messages with tips, skills, and reflection tasks that can be turned on at participants' discretion, which are then sent to participants’ mobile phones throughout the week. 6. A planning tool which allows participants to write messages to themselves that are sent to them at regular intervals throughout the week. Adapted intervention The adapted intervention will follow the same logic as the non-adapted intervention. The key difference between the two is that after the weekly self-monitoring and feedback on current consumption, participants will be given tailored exercises and advice for behaviour change which have been selected based on the participant’s drinking motives and readiness to change. Periodically, participants in the tailored intervention group will be asked to re-assess their readiness to change and motives, using the readiness to change questionnaire (treatment version) and the drinking motives questionnaire (short form). Matching will be based on the latest available data for participants concerning motives for drinking and readiness to change. The third (control) arm will be referred to national websites with information about alcohol and health (https://www.1177.se and https://www.iq.se). Both intervention groups will also be referred to these sites. The interventions last for 4 months and the final follow-up is at 8 months. _____ Previous interventions: Block randomisation with random block sizes of 3 and 6 to three arms (1:1:1). All randomisation procedures will be computerised. Non-adapted intervention: The non-adapted intervention will be delivered to participants via their mobile phones as a toolbox with six modules to manipulate these critical health-determining factors. The content of these modules is anchored in state-of-the-art empirical evidence for which active ingredients are effective for supporting reduced alcohol consumption, including behaviour substitution, problem-solving, goal setting, review of behavioural goals, self-monitoring, normative feedback, and understanding the consequences of alcohol consumption. The core element of the intervention is a text message sent to participants each Sunday afternoon. The message includes a prompt to self-monitor one’s current alcohol consumption and a link to a web-based screening tool. The screening tool assesses the past week's consumption, and participants are subsequently given access to the toolbox with six modules. In brief, these modules consist of: 1. Normative feedback on the past week’s consumption based on age and sex. 2. Information about some of the risks of drinking alcohol, including the risk of disease, how it may affect children in proximity, injuries, and traffic accidents. 3. A goal-setting tool with feedback on previously set goals and a timeline showing consumption over time. 4. Tips and teaching of skills which participants can use in their everyday life to immediately reduce their drinking, including tasks designed to make participants reflect on their behaviour. 5. Text messages with tips, skills, and reflection tasks that can be turned on at participants' discretion, which are then sent to participants’ mobile phones throughout the week. 6. A planning tool which allows participants to write messages to themselves that are sent to them at regular intervals throughout the week. Adapted intervention The adapted intervention will follow the same logic as the non-adapted intervention. The key difference between the two is that after the weekly self-monitoring, participants will be given a personalised version of the toolbox, where the content has been selected based on the participant’s drinking motives and readiness to change. Initially, this matching will be done based on how participants responded at baseline; however, every two weeks, participants in the adapted group will be asked to re-assess their readiness to change to measure if they have advanced (or reversed) along the readiness to change states. Participants will also be asked to re-assess their motives. Matching will, therefore, be based on the latest available data for participants concerning motives for drinking and readiness to change. The additional supportive messages sent to participants throughout the week will also be matched based on motives and readiness to change. The third (control) arm will be referred to a national website with information about alcohol and health (https://www.1177.se). The interventions last for 4 months and the final follow-up is at 8 months. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline, and at 2, 4 and 8 months post-randomisation: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 20/06/2025: |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1750 |
| Key inclusion criteria | 1. 18 years of age or older 2. Have access to a mobile phone 3. Classified as drinking at risky levels according to current Swedish guidelines |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
581 83
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Current individual participant data (IPD) sharing plan as of 25/06/2025: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marcus Bendtsen, marcus.bendtsen@liu.se or info@liu.se • The type of data that will be shared: Baseline and outcome measures (primary and secondary) at the individual level (anonymized). • Timing for availability: Anticipated 01/01/2028 • Whether consent from participants was required and obtained: Yes, consent was required and obtained. • Comments on data anonymization: Data will be anonymized. • Any ethical or legal restrictions: Ethical approval is required before data is shared. Previous IPD sharing plan: The datasets generated during and/or analysed during the current study are not expected to be made available due to GDPR limiting data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 11/07/2025 | 14/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/07/2025: Publication reference added.
25/06/2025: The following changes were made:
1. The recruitment start date was changed from 30/11/2024 to 01/02/2025.
2. The recruitment start date was changed from 31/10/2025 to 28/02/2026.
3. The individual participant data (IPD) sharing plan and summary were updated.
20/06/2025: The secondary outcome measures were updated.
26/02/2025: The following changes were made to the trial record:
1. The interventions were changed.
2. The secondary outcome measures were changed.
21/10/2024: The recruitment start date was changed from 31/10/2024 to 30/11/2024.
12/06/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
