Alcohol Use Disorder Clinical Trial
Official title:
Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial
| Verified date | November 2023 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.
| Status | Completed |
| Enrollment | 1170 |
| Est. completion date | November 30, 2019 |
| Est. primary completion date | November 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: AUDIT-score >16 points and/or at least 3 criteria of alcohol dependence (ICD-10) Exclusion Criteria: Inadequate Swedish language skills No Internet access |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet, Department of Public Health Sciences | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Public Health Agency of Sweden, Region Stockholm |
Sweden,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The Readiness Ruler (Scores between 0 and 100) | Scores between 0 and 100. In this study, "I am not ready to change my drinking habits" and "I am very much ready to change my drinking habits". | 3, 6, 12 and 24 months | |
| Other | Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website) | Number of visits and number of completed exercises in the Internet based program and website | From baseline to 3 months | |
| Other | Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention ) | 4 scale questions on the users alliance with the internet based intervention (program and/or website) | 2 and 5 weeks | |
| Primary | Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days) | Change in total in consumption of alcohol last 7 days | 3, 6, 12 and 24 months | |
| Secondary | Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days) | Change in number of standard drinks per day during last 7 days | 3, 6, 12 and 24 months | |
| Secondary | Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days) | Change in number of consumption days during last 7 days | 3, 6, 12 and 24 months | |
| Secondary | Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days) | Change in number of days binge-drinking days during last 7 days | 3, 6, 12 and 24 months | |
| Secondary | Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met) | Change in number of criteria for alcohol dependence met | 3, 6, 12 and 24 months | |
| Secondary | Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met) | Change in number of criteria for alcohol use disorder met | 3, 6, 12 and 24 months | |
| Secondary | Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use) | Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems) | 3, 6, 12 and 24 months | |
| Secondary | Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score) | Change in total MADRS-S score, as a summarized measure of depression | 3, 6, 12 and 24 months | |
| Secondary | Generalised Anxiety Disorder Assessment (GAD-7) | Change in total GAD-7 score, as a summarized measure of anxiety | 3, 6, 12 and 24 months | |
| Secondary | The EuroQol generic health index (EQ5D) | Change in total EQ5D score, as a summarized measure of quality of life | 3, 6, 12 and 24 months | |
| Secondary | Questions about help-seeking behavior | Change in help-seeking for alcohol related problems from professionals | 3, 6, 12 and 24 months | |
| Secondary | Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends) | Change in help-seeking for alcohol related problems from family and friends | 3, 6, 12 and 24 months |
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|---|---|---|---|
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