Clinical trial NCT05037630: Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Official title: Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2021-09-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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: 3 months after intervention
measure: Heavy drinking days (based on Time Line Follow Back)
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Standardized drinks per week (based on Time Line Follow Back)
timeFrame: Immediately after the intervention
measure: Heavy drinking days (based on Time Line Follow Back)
timeFrame: Immediately after the intervention
measure: Diagnostic criteria Alcohol Use Disorder
timeFrame: 3 months after intervention
measure: Diagnostic criteria Alcohol Use Disorder
timeFrame: Immediately after the intervention
measure: System Usability Scale
timeFrame: Immediately after the intervention
measure: Credibility/Expectancy questionnaire
timeFrame: Immediately after the intervention
measure: Alcohol Use Disorders Identification Test
timeFrame: 3 months after intervention
measure: Alcohol Use Disorders Identification Test
timeFrame: Immediately after the intervention
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: 3 months after intervention
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Immediately after the intervention
measure: Penn Alcohol Craving Scale
timeFrame: 3 months after intervention
measure: Penn Alcohol Craving Scale
timeFrame: Immediately after the intervention
measure: Patient Health Questionnaire 9
timeFrame: 3 months after intervention
measure: Patient Health Questionnaire 9
timeFrame: Immediately after the intervention
measure: Generalized Anxiety Disorder 7
timeFrame: 3 months after intervention
measure: Generalized Anxiety Disorder 7
timeFrame: Immediately after the intervention
Other outcomes:
measure: Behavioral engagement
timeFrame: Immediately after the intervention
measure: Telephone interview on perceptions of intervention
timeFrame: Immediately after the intervention
Locations:
city: Stockholm
country: Sweden
facility: Centrum för Psykiatriforskning
Study officials:
References: