Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Karolinska Institutet300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Drinking Excessive

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Time frame: Immediately after the intervention

Secondary Outcomes

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

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

Time frame: 12 months after intervention

Diagnostic criteria Alcohol Use Disorder

Using SCID-5, number of diagnostic criteria 0-11, lower is better

Time frame: 6 months after intervention

Credibility/Expectancy questionnaire

Credibility/Expectancy questionnaire, score range 0-50, higher is better

Time frame: 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

Time frame: 12 months after intervention

Brunnsviken Brief Quality of Life Scale

Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better

Time frame: 12 months after intervention

Penn Alcohol Craving Scale

Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better

Time frame: 12 months after intervention

Patient Health Questionnaire 9

Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better

Time frame: 12 months after intervention

Generalized Anxiety Disorder 7

Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better

Time frame: 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

Time frame: 12 months after intervention

Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts