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Completed

NCT Number: NCT02671019

Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment. 2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:

Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
  • Resident in Stockholm County

Exclusion criteria

  • Lack of understanding of the Swedish language.
  • Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
  • Doctor's assessment that there is a need for medication for alcohol dependence.

Treatment and study plan

Guide to better alcohol habits

Behavioral

A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

Primary outcomes

  1. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    Time frame: 3 months post-randomization

Secondary outcomes

  1. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    Time frame: 6 months post-randomization

  2. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    Time frame: 12 months post-randomization

  3. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method

    Time frame: 24 months post-randomization

  4. Alcohol Use Disorders Identification Test score

    Time frame: 3 months post-randomization

  5. Alcohol Use Disorders Identification Test score

    Time frame: 6 months post-randomization

  6. Alcohol Use Disorders Identification Test score

    Time frame: 12 months post-randomization

  7. Alcohol Use Disorders Identification Test score

    Time frame: 24 months post-randomization

  8. Number of criteria for alcohol dependence according to International Classification of Diseases - 10

    Time frame: 3 months post-randomization

  9. Number of criteria for alcohol dependence according to International Classification of Diseases - 10

    Time frame: 6 months post-randomization

  10. Number of criteria for alcohol dependence according to International Classification of Diseases - 10

    Time frame: 12 months post-randomization

  11. Number of criteria for alcohol dependence according to International Classification of Diseases - 10

    Time frame: 24 months post-randomization

  12. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V

    Time frame: 3 months post-randomization

  13. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V

    Time frame: 6 months post-randomization

  14. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V

    Time frame: 12 months post-randomization

  15. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V

    Time frame: 24 months post-randomization

  16. Number of days absent from work due to illness

    Time frame: 3 months post-randomization

  17. Number of days absent from work due to illness

    Time frame: 6 months post-randomization

  18. Number of days absent from work due to illness

    Time frame: 12 months post-randomization

  19. Number of days absent from work due to illness

    Time frame: 24 months post-randomization

  20. Score on Montgomery-Åsberg Depression Rating Scale

    Time frame: 3 months post-randomization

  21. Score on Montgomery-Åsberg Depression Rating Scale

    Time frame: 6 months post-randomization

  22. Score on Montgomery-Åsberg Depression Rating Scale

    Time frame: 12 months post-randomization

  23. Score on Montgomery-Åsberg Depression Rating Scale

    Time frame: 24 months post-randomization

  24. Score on Generalised Anxiety Disorder 7-item scale

    Time frame: 3 months post-randomization

  25. Score on Generalised Anxiety Disorder 7-item scale

    Time frame: 6 months post-randomization

  26. Score on Generalised Anxiety Disorder 7-item scale

    Time frame: 12 months post-randomization

  27. Score on Generalised Anxiety Disorder 7-item scale

    Time frame: 24 months post-randomization

  28. Score on EQ-5D measuring the quality of life

    Time frame: 3 months post-randomization

  29. Score on EQ-5D measuring the quality of life

    Time frame: 6 months post-randomization

  30. Score on EQ-5D measuring the quality of life

    Time frame: 12 months post-randomization

  31. Score on EQ-5D measuring the quality of life

    Time frame: 24 months post-randomization

  32. Cost for treatment

    Time frame: 3 months post-randomization

  33. Cost for treatment

    Time frame: 6 months post-randomization

  34. Cost for treatment

    Time frame: 12 months post-randomization

  35. Cost for treatment

    Time frame: 24 months post-randomization

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2025
First posted
Feb 2, 2016
Registry last updated
Sep 15, 2026

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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