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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT05037630
Collaborator
Region Stockholm (Other)
36
Enrollment
1
Location
1
Arm
7.1
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-guided Digital Tool for Problematic Alcohol Use
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Actual Study Start Date :
Sep 27, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Self-guided Digital Tool for Problematic Alcohol Use

Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention.

Behavioral: Self-guided Digital Tool for Problematic Alcohol Use
See arm/group-description
Other Names:
  • ALVA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Standardized drinks per week (based on Time Line Follow Back) [3 months after intervention]

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

    2. Heavy drinking days (based on Time Line Follow Back) [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 Outcome Measures

    1. 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)

    2. Heavy drinking days (based on Time Line Follow Back) [Immediately after the 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)

    3. Diagnostic criteria Alcohol Use Disorder [3 months after intervention]

      Using SCID-5

    4. Diagnostic criteria Alcohol Use Disorder [Immediately after the intervention]

      Using SCID-5

    5. System Usability Scale [Immediately after the intervention]

      System Usability Scale (SUS), score range 0-100, higher is better.

    6. Credibility/Expectancy questionnaire [Immediately after the intervention]

      Credibility/Expectancy questionnaire, score range 0-50, higher is better

    7. Alcohol Use Disorders Identification Test [3 months after intervention]

      Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better

    8. Alcohol Use Disorders Identification Test [Immediately after the intervention]

      Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better

    9. Brunnsviken Brief Quality of Life Scale [3 months after intervention]

      Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better

    10. Brunnsviken Brief Quality of Life Scale [Immediately after the intervention]

      Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better

    11. Penn Alcohol Craving Scale [3 months after intervention]

      Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better

    12. Penn Alcohol Craving Scale [Immediately after the intervention]

      Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better

    13. Patient Health Questionnaire 9 [3 months after intervention]

      Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better

    14. Patient Health Questionnaire 9 [Immediately after the intervention]

      Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better

    15. Generalized Anxiety Disorder 7 [3 months after intervention]

      Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better

    16. Generalized Anxiety Disorder 7 [Immediately after the intervention]

      Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better

    Other Outcome Measures

    1. Behavioral engagement [Immediately after the intervention]

      Number of alcohol diary entries

    2. Telephone interview on perceptions of intervention [Immediately after the intervention]

      Quotes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centrum för Psykiatriforskning Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet
    • Region Stockholm

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin Kraepelien, Licensed clinical psychologist, Principal investigator, PhD, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT05037630
    Other Study ID Numbers:
    • ALCOHOLDIARY1
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alcohol Drinking

    Study Results

    No Results Posted as of May 23, 2022