Comparing immediate and delayed initiation of online support for excessive alcohol consumption
| ISRCTN | ISRCTN14959594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14959594 |
- Submission date
- 26/01/2021
- Registration date
- 01/02/2021
- Last edited
- 16/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study aims to investigate the effects of immediate versus delayed initiation of online support for excessive alcohol consumption. The treatment will be access to online materials that are believed to help people reduce their drinking.
Who can participate?
Anyone aged 18 or older who has consumed either more than 6 drinks of alcohol on at least one occasion the past month, or who has consumed at least 10 drinks the past week can participate.
What does the study involve?
Participants will be randomly allocated to two groups. Half of the participants will receive access to online materials immediately. The other half of the participants will have to wait for 1 month to receive access to online materials. The study involves answering a few online questions and reading some online material.
What are the possible benefits and risks of participating?
The benefits including getting access to material which are believed to help people reduce their drinking. A possible risk is that receiving materials believed to help individuals, and finding that it does not help, could be de-motivating.
Where is the study run from?
Linköping University (Sweden)
When is the study starting and how long is it expected to run for?
From March 2021 to June 2023
Who is funding the study?
This trial is investigator-initiated and funded
Who is the main contact?
Dr Marcus Bendtsen
marcus.bendtsen@liu.se
Contact information
Scientific
Linköpings universitet
Linköping
S-58183
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|---|
| Phone | +46 (0)13 28 69 75 |
| marcus.bendtsen@liu.se |
Study information
| Study design | 2-arm double-blind randomized wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of a waiting list control design on alcohol consumption among online help-seekers |
| Study objectives | The objective of this study is to estimate the effects immediate versus delayed initiation of online support for excessive alcohol consumption. The primary effects being estimated are the total effect and moderation by readiness to change. |
| Ethics approval(s) | Approved 25/01/2021, the Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 2020-06267 |
| Health condition(s) or problem(s) studied | Excessive alcohol consumption |
| Intervention | This trial will use a randomised (1:1) wait list controlled design. Block randomisation will be used with random block sizes of 2 and 4. Individuals in both groups will receive the same personalised feedback and advice based on a baseline questionnaire. The material has been developed from previous research and is based around social cognitive theories of health behaviour. This includes: 1. Feedback on current consumption in relation to recommendations 2. Content to increase motivation and self-efficacy 3. Advice on what to do to reduce drinking and avoid environmental triggers The treatment takes between 5 and 20 min and the follow-up period will be one month. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Frequency of heavy episodic drinking in the past month assessed by asking for the number of times in the past month the participant has consumed 6 or more drinks on one occasion at baseline and 1 month 2. Overall consumption the past week assessed by asking participants to report their consumption day-by-day at baseline and 1 month |
| Secondary outcome measures | 1. Readiness to change measured using the readiness to change questionnaire (treatment version) at baseline and 1 month |
| Overall study start date | 01/12/2020 |
| Completion date | 20/06/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A Bayesian group sequential design will be used, thus no fixed target exists. We expect no more than 1500 participants, but there are target posterior probabilities that will dictate this. |
| Key inclusion criteria | 1. Report having consumed ≥6 standard drinks on ≥1 occasion in the past month, or having consumed ≥10 standard drinks in the past week |
| Key exclusion criteria | 1. Aged ≤18 years |
| Date of first enrolment | 29/10/2021 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
581 83
Sweden
Sponsor information
University/education
Linköpings universitet
Linköping
581 83
Sweden
| Phone | +46 (0)13-28 10 00 |
|---|---|
| infocenter@liu.se | |
| Website | http://www.liu.se/?l=en |
"ROR" |
https://ror.org/05ynxx418 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in open access peer-reviewed journal. A research protocol with a statistical analysis plan will be submitted prior to trial commencement. |
| IPD sharing plan | Deidentified individual participant-level data will be made available upon reasonable request following publication. The data may only be used for analyses that are congruent with the informed consent given by participants and the ethical approval of the trial. A registered study protocol must be available before data is shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/08/2021 | 31/08/2021 | Yes | No |
Editorial Notes
16/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/03/2023 to 20/06/2023.
2. The intention to publish date was changed from 01/06/2023 to 01/01/2024.
3. The plain English summary was updated to reflect these changes.
17/11/2021: The recruitment start date has been changed from 01/11/2021 to 29/10/2021.
18/10/2021: The recruitment start date has been changed from 01/10/2021 to 01/11/2021.
31/08/2021: Publication reference added.
11/08/2021: Participant level data has been changed from "To be made available at a later date" to "Available on request" and the IPD sharing statement has been added.
17/06/2021: The recruitment start date has been changed from 01/06/2021 to 01/10/2021.
19/04/2021: The recruitment start date has been changed from 15/04/2021 to 01/06/2021.
15/03/2021: The recruitment start date has been changed from 01/03/2021 to 15/04/2021.
28/01/2021: Trial’s existence confirmed by the Swedish Ethical Review Authority.
