Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

NCT ID: NCT05649982

Last Updated: 2025-03-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drinking Excessive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2\*2 factorial experiment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The level of added guidance received will be open to the participants. The main outcome of Alcohol consumption will be self-rated.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital Tool for Problematic Alcohol Use

This is the base version of the intervention with no added guidance.

Group Type EXPERIMENTAL

ALVA

Intervention Type BEHAVIORAL

Behavioural digital self-help intervention

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview

This is the same intervention as the base version, with an added mid-treatment telephone interview.

Group Type EXPERIMENTAL

ALVA

Intervention Type BEHAVIORAL

Behavioural digital self-help intervention

Digital Tool for Problematic Alcohol Use + Written Guidance

This is the same intervention as the base version, with added weekly written guidance.

Group Type EXPERIMENTAL

ALVA

Intervention Type BEHAVIORAL

Behavioural digital self-help intervention

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance

This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview.

Group Type EXPERIMENTAL

ALVA

Intervention Type BEHAVIORAL

Behavioural digital self-help intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALVA

Behavioural digital self-help intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martin Kraepelien

Licensed clinical psychologist, Principal investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Psychiatry Research

Stockholm, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martin Kraepelien, PhD

Role: CONTACT

+46703017500

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nitya Jayaram-Lindström, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Sundstrom C, Ivanova E, Lindner P, Johansson M, Kraepelien M. Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)-protocol for a randomized factorial optimization trial. Trials. 2024 Feb 21;25(1):136. doi: 10.1186/s13063-024-07981-6.

Reference Type DERIVED
PMID: 38383426 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALCOHOLDIARY2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brief Intervention for Heavy Drinkers
NCT00728767 COMPLETED PHASE3