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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05037630
Enrollment
36
Registered
2021-09-08
Start date
2021-09-27
Completion date
2022-04-30
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Consumption

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.

Interventions

BEHAVIORALSelf-guided Digital Tool for Problematic Alcohol Use

See arm/group-description

Sponsors

Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

MeasureTime frameDescription
Heavy drinking days (based on Time Line Follow Back)3 months after interventionChanges 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)
Standardized drinks per week (based on Time Line Follow Back)3 months after interventionChanges in standardized drinks per week (using Time Line Follow Back)

Secondary

MeasureTime frameDescription
Heavy drinking days (based on Time Line Follow Back)Immediately after the interventionChanges 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)
Diagnostic criteria Alcohol Use Disorder3 months after interventionUsing SCID-5
System Usability ScaleImmediately after the interventionSystem Usability Scale (SUS), score range 0-100, higher is better.
Credibility/Expectancy questionnaireImmediately after the interventionCredibility/Expectancy questionnaire, score range 0-50, higher is better
Brunnsviken Brief Quality of Life Scale3 months after interventionBrunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Penn Alcohol Craving Scale3 months after interventionPenn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Patient Health Questionnaire 93 months after interventionPatient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Generalized Anxiety Disorder 73 months after interventionGeneralized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Alcohol Use Disorders Identification Test3 months after interventionAlcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Standardized drinks per week (based on Time Line Follow Back)Immediately after the interventionChanges in standardized drinks per week (using Time Line Follow Back)

Other

MeasureTime frameDescription
Behavioral engagementImmediately after the interventionNumber of alcohol diary entries
Telephone interview on perceptions of interventionImmediately after the interventionQuotes

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026