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Internet-based vs Face-to-face Treatment for Alcohol Dependence (IMS)

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ClinicalTrials.gov Identifier: NCT02888002
Recruitment Status : Active, not recruiting
First Posted : September 2, 2016
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcohol Dependence Harmful Alcohol Use Alcohol Use Disorder Behavioral: Guide to better alcohol habits Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-based treatment
"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.
Behavioral: Guide to better alcohol habits
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

Experimental: Face-to-face treatment
"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.
Behavioral: Guide to better alcohol habits
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888002


Locations
Sweden
Karolinska Institutet, Department of Public Health Sciences
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Sven Andreasson, MD, PhD Karolinska Institutet

Additional Information:
Publications:
Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02888002     History of Changes
Other Study ID Numbers: 2014/1758-31/2-2
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs