Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Karolinska Institute

Status: Enrolling

Conditions: Drinking Excessive

Treatments: Behavioral: ALVA

Study type: Interventional

Funder types: Other

Identifiers

NCT05649982

ALCOHOLDIARY2

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Digital Tool for Problematic Alcohol Use

Experimental group

Description:

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

Treatment:

Behavioral: ALVA

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview

Experimental group

Description:

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

Treatment:

Behavioral: ALVA

Digital Tool for Problematic Alcohol Use + Written Guidance

Experimental group

Description:

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

Treatment:

Behavioral: ALVA

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

Experimental group

Description:

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

Treatment:

Behavioral: ALVA