Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

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.

Study Overview

• Status: Recruiting
• Conditions: Drinking Excessive
• Intervention / Treatment: Behavioral: ALVA

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Kraepelien, PhD; Phone Number: +46703017500; Email: martin.kraepelien@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Centre for Psychiatry Research
    • Contact: Nitya Jayaram-Lindström, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Tool for Problematic Alcohol Use; This is the base version of the intervention with no added guidance.	Behavioral: ALVA; Behavioural digital self-help intervention
Experimental: 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.	Behavioral: ALVA; Behavioural digital self-help intervention
Experimental: Digital Tool for Problematic Alcohol Use + Written Guidance; This is the same intervention as the base version, with added weekly written guidance.	Behavioral: ALVA; Behavioural digital self-help intervention
Experimental: 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.	Behavioral: ALVA; Behavioural digital self-help intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized drinks per week (based on Time Line Follow Back)	Changes in standardized drinks per week (using Time Line Follow Back)	12 months after intervention
Credibility/Expectancy questionnaire	Credibility/Expectancy questionnaire, score range 0-50, higher is better	Mid-intervention (4 weeks after intervention start)
Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	12 months after intervention
Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	12 months after intervention
Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	12 months after intervention
Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	12 months after intervention
Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	12 months after intervention
Readiness to change questionnaire	Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase	12 months after intervention
Diagnostic criteria Alcohol Use Disorder	Using SCID-5, number of diagnostic criteria 0-11, lower is better	6 months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician time	Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: ALCOHOLDIARY2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD available anonymized on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No