Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

NCT05649982 | Recruiting

• 1 other identifier: ALCOHOLDIARY2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Drinking Excessive

Outcome Measures

Primary Outcomes (1)

• Standardized drinks per week (based on Time Line Follow Back)

  Changes in standardized drinks per week (using Time Line Follow Back)

  Immediately after the intervention

Secondary Outcomes (9)

• Standardized drinks per week (based on Time Line Follow Back)

  12 months after intervention

• Diagnostic criteria Alcohol Use Disorder

  6 months after intervention

• Credibility/Expectancy questionnaire

  Mid-intervention (4 weeks after intervention start)

• Alcohol Use Disorders Identification Test

  12 months after intervention

• Brunnsviken Brief Quality of Life Scale

  12 months after intervention

Other Outcomes (1)

• Clinician time

  Immediately after the intervention

Study Arms (4)

Digital Tool for Problematic Alcohol Use

EXPERIMENTAL

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

Behavioral: ALVA

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview

EXPERIMENTAL

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

Behavioral: ALVA

Digital Tool for Problematic Alcohol Use + Written Guidance

EXPERIMENTAL

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

Behavioral: ALVA

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

EXPERIMENTAL

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

Behavioral: ALVA

Interventions

ALVA BEHAVIORAL

Behavioural digital self-help intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Access to internet
• ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)

You may not qualify if:

• Insufficient knowledge of the Swedish language
• Difficulties reading or writing related to a digital intervention.
• Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).
• High suicide risk based on telephone assessment.
• Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Centre for Psychiatry Research

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 38383426 DERIVED

Central Study Contacts

Martin Kraepelien, PhD

CONTACT

+46703017500; martin.kraepelien@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The level of added guidance received will be open to the participants. The main outcome of Alcohol consumption will be self-rated.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed clinical psychologist, Principal investigator, PhD

Model Details: 2\*2 factorial experiment

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 11, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

SE (1)