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

Primary Purpose

Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Guide to better alcohol habits
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Public Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Internet-based treatment

Face-to-face treatment

Arm Description

"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.

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

Outcomes

Primary Outcome Measures

Time Line Follow Back (TLFB)
Change in number of standard drinks per day during last 7 days

Secondary Outcome Measures

Time Line Follow Back (TLFB) Change in number of consumption days
Change in number of drinking days during last 7 days
Time Line Follow Back (TLFB) Change in number of days binge-drinking days
Change in number of binge-drinking days during last 7 days
Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Change in Quantity, Frequency and Binge-drinking scores during the time since last reported
Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use since last reported
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Change in total MADRS-S score, as a summarized measure of depression
Generalised Anxiety Disorder Assessment (GAD-7)
Change in total GAD-7 score, as a summarized measure of anxiety
Questions about help-seeking behavior from family and friends
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
Questions about help-seeking behavior from professionals
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

Full Information

First Posted
January 17, 2016
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT02888002
Brief Title
Internet-based vs Face-to-face Treatment for Alcohol Dependence
Acronym
IMS
Official Title
Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based treatment
Arm Type
Experimental
Arm Description
"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.
Arm Title
Face-to-face treatment
Arm Type
Experimental
Arm Description
"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.
Intervention Type
Behavioral
Intervention Name(s)
Guide to better alcohol habits
Other Intervention Name(s)
Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), Behavioral Self-Control Training, eChange
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time Line Follow Back (TLFB)
Description
Change in number of standard drinks per day during last 7 days
Time Frame
3, 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Time Line Follow Back (TLFB) Change in number of consumption days
Description
Change in number of drinking days during last 7 days
Time Frame
3, 6, 12 and 24 months
Title
Time Line Follow Back (TLFB) Change in number of days binge-drinking days
Description
Change in number of binge-drinking days during last 7 days
Time Frame
3, 6, 12 and 24 months
Title
Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Description
Change in Quantity, Frequency and Binge-drinking scores during the time since last reported
Time Frame
3, 6, 12 and 24 months
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Change in total AUDIT score, as a summarized measure of alcohol use since last reported
Time Frame
3, 6, 12 and 24 months
Title
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Description
Change in total MADRS-S score, as a summarized measure of depression
Time Frame
3, 6, 12 and 24 months
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
Change in total GAD-7 score, as a summarized measure of anxiety
Time Frame
3, 6, 12 and 24 months
Title
Questions about help-seeking behavior from family and friends
Description
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
Time Frame
3, 6, 12 and 24 months
Title
Questions about help-seeking behavior from professionals
Description
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
Time Frame
3, 6, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
The Readiness Ruler
Description
Scores between 0 and 100. In this study, "How ready to change reduce my drinking" and "How ready to quit drinking".
Time Frame
3, 6, 12 and 24 month
Title
Use of Internet-based program and website
Description
Number of visits and number of completed exercises in the Internet-based program and website
Time Frame
From baseline to 3 months
Title
Session rating scale (SRS)
Description
4 scale questions on the user's alliance with the counselor
Time Frame
2 and 5 weeks in to treatment
Title
Working Alliance Inventory-Short Revised (WAI-SR)
Description
12 questions on working alliance adapted for Internet-based programs
Time Frame
2 and 5 weeks in to treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Andreasson, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Public Health Sciences
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25300885
Citation
Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.
Results Reference
background
Links:
URL
http://riddargatan1.se
Description
Clinic website

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

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