Drinking Excessive
Conditions
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.
Interventions
BEHAVIORALALVA
Behavioural digital self-help intervention
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The level of added guidance received will be open to the participants. The main outcome of Alcohol consumption will be self-rated.
Intervention model description
2\*2 factorial experiment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Sweden
Outcome results
None listed