Clinical trial NCT05649982: Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
Official title: Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drinking Excessive
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2\*2 factorial experiment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Standardized drinks per week (based on Time Line Follow Back)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Standardized drinks per week (based on Time Line Follow Back)
timeFrame: 12 months after intervention
measure: Diagnostic criteria Alcohol Use Disorder
timeFrame: 6 months after intervention
measure: Credibility/Expectancy questionnaire
timeFrame: Mid-intervention (4 weeks after intervention start)
measure: Alcohol Use Disorders Identification Test
timeFrame: 12 months after intervention
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: 12 months after intervention
measure: Penn Alcohol Craving Scale
timeFrame: 12 months after intervention
measure: Patient Health Questionnaire 9
timeFrame: 12 months after intervention
measure: Generalized Anxiety Disorder 7
timeFrame: 12 months after intervention
measure: Readiness to change questionnaire
timeFrame: 12 months after intervention
Other outcomes:
measure: Clinician time
timeFrame: Immediately after the intervention
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research
Study officials:
References: