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NCT Number: NCT05649982

Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

The purpose of the study is to evaluate the effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a 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. The trial will be a 2*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.

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Key information

Conditions

Drinking Excessive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research

Stockholm, Sweden

Location status: Recruiting

Location contact

Nitya Jayaram-Lindström, PhD

CONTACT

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

ALVA

Behavioral

Behavioural digital self-help intervention

Primary 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)

Secondary outcomes

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

    Time frame: 12 months after intervention

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

  2. Diagnostic criteria Alcohol Use Disorder

    Time frame: 6 months after intervention

    Using SCID-5, number of diagnostic criteria 0-11, lower is better

  3. Credibility/Expectancy questionnaire

    Time frame: Mid-intervention (4 weeks after intervention start)

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

  4. Alcohol Use Disorders Identification Test

    Time frame: 12 months after intervention

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

  5. Brunnsviken Brief Quality of Life Scale

    Time frame: 12 months after intervention

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

  6. Penn Alcohol Craving Scale

    Time frame: 12 months after intervention

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

  7. Patient Health Questionnaire 9

    Time frame: 12 months after intervention

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

  8. Generalized Anxiety Disorder 7

    Time frame: 12 months after intervention

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

  9. Readiness to change questionnaire

    Time frame: 12 months after intervention

    Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase

Other outcomes

  1. Clinician time

    Time frame: Immediately after the intervention

    Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Kraepelien, PhD

CONTACT

[email protected]

+46703017500

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Mar 12, 2025

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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