Skills-training for Reducing Risky Alcohol Use in App Form
Sponsor:
Karolinska Institutet
Collaborators:
Information provided by (Responsible Party):
Anne H Berman，Karolinska Institutet
| Tracking Information | |||
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| First Submitted Date ICMJE | October 2, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | November 1, 2018 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Change (reduction) in alcohol consumption according to the 7-day Timeline Followback (TLFB)[ Time Frame: Time between baseline measure and 26-week followup ] Reduction in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Skills-training for Reducing Risky Alcohol Use in App Form |
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| Official Title ICMJE | Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population. |
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| Brief Summary | This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. The Telecoach web app delivers skills training in the form of exercises commonly used in psychosocial interventions for risky alcohol use. The controll condition is a web app providing information on the effects of alcohol on the consumers' health. |
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| Detailed Description | This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. Individuals seeking help for problematic alcohol use on the internet will get access to a webpage with information about the study. Individuals leaving informed consent are asked to fill out questionnaires about alcohol use, depression, anxiety and information on gender and weight. Those with excessive alcohol use (>14 standard glasses/week for men and > 9 for women) are randomized into one of two groups: 1. Access to the Telecoach web-app and 2. Access to a control condition with an information-providing web-app Outcomes on alcohol use are gathered by electronic self-registration at 6, 12 and 26 weeks after study initiation. Additional questions on the users' satisfaction with the app assigned to them and other support for problematic alcohol used during the research period at 26 weeks. The Telecoach web-app is a skills-training app developed for use on a mobile smart-phone. The skills-training components are common to psychosocial treatment protocols for problematic alcohol consumption. The control condition web-app is a simple text-based app providing information on the effects of alcohol on the consumers' health. Outcomes will be reported, analyzed and discussed in scientific article. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
1000 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 31, 2019 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - ≥ 18 years - excessive alcohol consumption defined as > 14 standard glasses for men and > 9 standard glasses or more for women on the TLFB. Exclusion Criteria: - Severe depression, defined as a MADRS-S score of > 30 - Sucide risk, defined as a MADRS-S, item 9 (Lust for life) score > 4 - Drug abuse, defined as a score of ≥ 8 on the DUDIT - fulfill 6 or more criteria for alcohol use disorder as defined in DSM-5 | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Sweden | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Anne H Berman，Karolinska Institutet | ||
| Study Sponsor ICMJE | Karolinska Institutet | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Karolinska Institutet | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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