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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based treatment | Experimental | "Guide to better alcohol habits online". An Internet-based treatment program with online counselor support. |
|
| Face-to-face treatment | Experimental | "Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Line Follow Back (TLFB) | Change in number of standard drinks per day during last 7 days | 3, 6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time Line Follow Back (TLFB) Change in number of consumption days | Change in number of drinking days during last 7 days | 3, 6, 12 and 24 months |
| Time Line Follow Back (TLFB) Change in number of days binge-drinking days |
| Measure | Description | Time Frame |
|---|---|---|
| The Readiness Ruler | Scores between 0 and 100. In this study, "How ready to change reduce my drinking" and "How ready to quit drinking". | 3, 6, 12 and 24 month |
| Use of Internet-based program and website |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Andreasson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Department of Public Health Sciences | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25300885 | Background | 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. |
| Label | URL |
|---|---|
| Clinic website | View source |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D062405 | Motivational Interviewing |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D037001 | Directive Counseling |
| D003376 | Counseling |
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|
Change in number of binge-drinking days during last 7 days
| 3, 6, 12 and 24 months |
| Alcohol Use Disorders Identification Test Consumption (AUDIT-C) | Change in Quantity, Frequency and Binge-drinking scores during the time since last reported | 3, 6, 12 and 24 months |
| Alcohol Use Disorders Identification Test (AUDIT) | Change in total AUDIT score, as a summarized measure of alcohol use since last reported | 3, 6, 12 and 24 months |
| Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) | Change in total MADRS-S score, as a summarized measure of depression | 3, 6, 12 and 24 months |
| Generalised Anxiety Disorder Assessment (GAD-7) | Change in total GAD-7 score, as a summarized measure of anxiety | 3, 6, 12 and 24 months |
| 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 | 3, 6, 12 and 24 months |
| 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 | 3, 6, 12 and 24 months |
Number of visits and number of completed exercises in the Internet-based program and website
| From baseline to 3 months |
| Session rating scale (SRS) | 4 scale questions on the user's alliance with the counselor | 2 and 5 weeks in to treatment |
| Working Alliance Inventory-Short Revised (WAI-SR) | 12 questions on working alliance adapted for Internet-based programs | 2 and 5 weeks in to treatment |
| D008605 |
| Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |