Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Study Overview
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Brief Summary
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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.

Official Title
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Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Conditions
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Drinking Excessive

Intervention / Treatment
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* Behavioral: ALVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Access to internet ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2*2 factorial experiment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Tool for Problematic Alcohol Use<br>This is the base version of the intervention with no added guidance. | Behavioral: ALVA<br>* Behavioural digital self-help intervention<br>|
| Experimental: Digital Tool for Problematic Alcohol Use + Extra Telephone Interview<br>This is the same intervention as the base version, with an added mid-treatment telephone interview. | Behavioral: ALVA<br>* Behavioural digital self-help intervention<br>|
| Experimental: Digital Tool for Problematic Alcohol Use + Written Guidance<br>This is the same intervention as the base version, with added weekly written guidance. | Behavioral: ALVA<br>* Behavioural digital self-help intervention<br>|
| Experimental: Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance<br>This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview. | Behavioral: ALVA<br>* Behavioural digital self-help intervention<br>|

What is the study measuring?
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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 | 
| Diagnostic criteria Alcohol Use Disorder | Using SCID-5, number of diagnostic criteria 0-11, lower is better | 6 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 |