Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Not Applicable

Recruiting

• Conditions: Drinking Excessive
• Interventions: Behavioral: ALVA

• Registration Number: NCT05649982
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Study Start: 2023-01-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Digital Tool for Problematic Alcohol Use + Extra Telephone Interview	ALVA	This is the same intervention as the base version, with an added mid-treatment telephone interview.
Digital Tool for Problematic Alcohol Use + Written Guidance	ALVA	This is the same intervention as the base version, with added weekly written guidance.
Digital Tool for Problematic Alcohol Use	ALVA	This is the base version of the intervention with no added guidance.
Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance	ALVA	This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview.

Primary Outcome Measures

Name	Time	Method
Standardized drinks per week (based on Time Line Follow Back)	Immediately after the intervention	Changes in standardized drinks per week (using Time Line Follow Back)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Psychiatry Research; 🇸🇪 Stockholm, Sweden