Feasibility Evaluation of a Self-guided 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 feasibility of a new monitored self-guided 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. An uncontrolled trial will explore participant's usability and treatment credibility ratings, behavioural engagement and preliminary effects on alcohol use.

Official Title
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Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use

Conditions
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Alcohol Consumption

Intervention / Treatment
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* Behavioral: Self-guided Digital Tool for Problematic Alcohol Use


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-guided Digital Tool for Problematic Alcohol Use<br>Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention. | Behavioral: Self-guided Digital Tool for Problematic Alcohol Use<br>* See arm/group-description<br>* Other names: ALVA;|

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) | 3 months after intervention | 
| Heavy drinking days (based on Time Line Follow Back) | Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back) | 3 months after 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) | Immediately after the intervention | 
| Heavy drinking days (based on Time Line Follow Back) | Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back) | Immediately after the intervention | 
| Diagnostic criteria Alcohol Use Disorder | Using SCID-5 | 3 months after intervention | 
| Diagnostic criteria Alcohol Use Disorder | Using SCID-5 | Immediately after the intervention | 
| System Usability Scale | System Usability Scale (SUS), score range 0-100, higher is better. | Immediately after the intervention | 
| Credibility/Expectancy questionnaire | Credibility/Expectancy questionnaire, score range 0-50, higher is better | Immediately after the intervention | 
| Alcohol Use Disorders Identification Test | Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better | 3 months after intervention | 
| Alcohol Use Disorders Identification Test | Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better | Immediately after the intervention | 
| Brunnsviken Brief Quality of Life Scale | Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better | 3 months after intervention | 
| Brunnsviken Brief Quality of Life Scale | Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better | Immediately after the intervention | 
| Penn Alcohol Craving Scale | Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better | 3 months after intervention | 
| Penn Alcohol Craving Scale | Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better | Immediately after the intervention | 
| Patient Health Questionnaire 9 | Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better | 3 months after intervention | 
| Patient Health Questionnaire 9 | Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better | Immediately after the intervention | 
| Generalized Anxiety Disorder 7 | Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better | 3 months after intervention | 
| Generalized Anxiety Disorder 7 | Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better | Immediately after the intervention |