NCT05649982 Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
| NCT ID | NCT05649982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Drinking Excessive |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-01-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. The trial will be a 2\*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age 2. Access to internet 3. ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT) Exclusion Criteria: 1. Insufficient knowledge of the Swedish language 2. Difficulties reading or writing related to a digital intervention. 3. Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use). 4. High suicide risk based on telephone assessment. 5. Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05649982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drinking Excessive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649982 currently recruiting?
Yes, NCT05649982 is actively recruiting participants. Contact the research team at martin.kraepelien@ki.se for enrollment information.
Where is the NCT05649982 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05649982 clinical trial?
NCT05649982 is sponsored by Karolinska Institutet. The trial plans to enroll 300 participants.