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Completed

NCT Number: NCT02888002

Internet-based vs Face-to-face Treatment for Alcohol Dependence

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

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Key information

Conditions

Alcohol Abuse Alcohol Dependence Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Harmful Alcohol Use Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Public Health Sciences

Stockholm, 17176, Sweden

About this study

A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)

Exclusion criteria

  • Risk of severe withdrawal symptoms.
  • Risk of suicide.
  • Other psychiatric diagnosis that requires current treatment.
  • Need for medication for alcohol dependence.
  • Inadequate Swedish language skills.
  • No Internet access

Treatment and study plan

Guide to better alcohol habits

Behavioral

A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.

Other names: Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), Behavioral Self-Control Training, eChange

Primary outcomes

  1. Time Line Follow Back (TLFB)

    Time frame: 3, 6, 12 and 24 months

    Change in number of standard drinks per day during last 7 days

Secondary outcomes

  1. Time Line Follow Back (TLFB) Change in number of consumption days

    Time frame: 3, 6, 12 and 24 months

    Change in number of drinking days during last 7 days

  2. Time Line Follow Back (TLFB) Change in number of days binge-drinking days

    Time frame: 3, 6, 12 and 24 months

    Change in number of binge-drinking days during last 7 days

  3. Alcohol Use Disorders Identification Test Consumption (AUDIT-C)

    Time frame: 3, 6, 12 and 24 months

    Change in Quantity, Frequency and Binge-drinking scores during the time since last reported

  4. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: 3, 6, 12 and 24 months

    Change in total AUDIT score, as a summarized measure of alcohol use since last reported

  5. Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)

    Time frame: 3, 6, 12 and 24 months

    Change in total MADRS-S score, as a summarized measure of depression

  6. Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 3, 6, 12 and 24 months

    Change in total GAD-7 score, as a summarized measure of anxiety

  7. Questions about help-seeking behavior from family and friends

    Time frame: 3, 6, 12 and 24 months

    Change in help-seeking for alcohol related problems from family and friends. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., & Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387

  8. Questions about help-seeking behavior from professionals

    Time frame: 3, 6, 12 and 24 months

    Change in help-seeking for alcohol related problems from professionals. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., & Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387

Other outcomes

  1. The Readiness Ruler

    Time frame: 3, 6, 12 and 24 month

    Scores between 0 and 100. In this study, "How ready to change reduce my drinking" and "How ready to quit drinking".

  2. Use of Internet-based program and website

    Time frame: From baseline to 3 months

    Number of visits and number of completed exercises in the Internet-based program and website

  3. Session rating scale (SRS)

    Time frame: 2 and 5 weeks in to treatment

    4 scale questions on the user's alliance with the counselor

  4. Working Alliance Inventory-Short Revised (WAI-SR)

    Time frame: 2 and 5 weeks in to treatment

    12 questions on working alliance adapted for Internet-based programs

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial

Acronym: IMS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2016
Registry last updated
Sep 2, 2020

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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