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Clinical Trials/NCT05037630
NCT05037630CompletedNot Applicable

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

Karolinska Institutet1 site in 1 country36 target enrollmentStarted: September 27, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Standardized drinks per week (based on Time Line Follow Back)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Standardized drinks per week (based on Time Line Follow Back)

Time Frame: 3 months after intervention

Changes in standardized drinks per week (using Time Line Follow Back)

Heavy drinking days (based on Time Line Follow Back)

Time Frame: 3 months after intervention

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)

Secondary Outcomes

  • Standardized drinks per week (based on Time Line Follow Back)(Immediately after the intervention)
  • Credibility/Expectancy questionnaire(Immediately after the intervention)
  • Brunnsviken Brief Quality of Life Scale(Immediately after the intervention)
  • Patient Health Questionnaire 9(Immediately after the intervention)
  • Generalized Anxiety Disorder 7(Immediately after the intervention)
  • Heavy drinking days (based on Time Line Follow Back)(Immediately after the intervention)
  • Diagnostic criteria Alcohol Use Disorder(Immediately after the intervention)
  • System Usability Scale(Immediately after the intervention)
  • Penn Alcohol Craving Scale(Immediately after the intervention)
  • Alcohol Use Disorders Identification Test(Immediately after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Kraepelien

Licensed clinical psychologist, Principal investigator, PhD

Karolinska Institutet

Study Sites (1)

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