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Completed

NCT Number: NCT05037630

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

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.

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Key information

Conditions

Alcohol Consumption Alcohol Drinking Behavior Drinking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum för Psykiatriforskning

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-guided Digital Tool for Problematic Alcohol Use

Behavioral

See arm/group-description

Other names: ALVA

Primary outcomes

  1. 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)

  2. 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

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

    Time frame: 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)

    Time frame: 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

    Time frame: 3 months after intervention

    Using SCID-5

  4. Diagnostic criteria Alcohol Use Disorder

    Time frame: Immediately after the intervention

    Using SCID-5

  5. System Usability Scale

    Time frame: Immediately after the intervention

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

  6. Credibility/Expectancy questionnaire

    Time frame: Immediately after the intervention

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

  7. Alcohol Use Disorders Identification Test

    Time frame: 3 months after intervention

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

  8. Alcohol Use Disorders Identification Test

    Time frame: Immediately after the intervention

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

  9. Brunnsviken Brief Quality of Life Scale

    Time frame: 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

    Time frame: Immediately after the intervention

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

  11. Penn Alcohol Craving Scale

    Time frame: 3 months after intervention

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

  12. Penn Alcohol Craving Scale

    Time frame: Immediately after the intervention

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

  13. Patient Health Questionnaire 9

    Time frame: 3 months after intervention

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

  14. Patient Health Questionnaire 9

    Time frame: Immediately after the intervention

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

  15. Generalized Anxiety Disorder 7

    Time frame: 3 months after intervention

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

  16. Generalized Anxiety Disorder 7

    Time frame: Immediately after the intervention

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

Other outcomes

  1. Behavioral engagement

    Time frame: Immediately after the intervention

    Number of alcohol diary entries

  2. Telephone interview on perceptions of intervention

    Time frame: Immediately after the intervention

    Quotes

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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