Skills-training for Reducing Risky Alcohol Use in App Form

Not Applicable

Completed

• Conditions: Alcohol Abuse; Alcohol Dependence; Alcohol Use Disorder; Alcohol; Harmful Use; Alcohol Drinking
• Interventions: Behavioral: Telecoach; Behavioral: TeleCoach control

• Registration Number: NCT03696888
• Lead Sponsor: Karolinska Institutet

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.

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 a scientific article.

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Study Start: 2018-12-07
• Primary Completion: 2020-01-15
• Study Completion: 2020-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

• ≥ 18 years
• Risky alcohol consumption defined as Alcohol Use Disorders Identification Test (AUDIT) scores of ≥6 points for women and ≥ 8 points for men.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telecoach	Telecoach	A skills-training web-app teaching skills for reducing problematic alcohol use.
TeleCoach control	TeleCoach control	A web-app giving information on health-related consequences of alcohol consumption.

Primary Outcome Measures

Name	Time	Method
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)	Time between screening measure and 26-week followup	Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.

Secondary Outcome Measures

Name	Time	Method
Penn Alcohol Craving Scale (PACS)	Baseline, 6, 12 and 26 week followups.	5 items to measure participants' craving for alcohol.
Drug Use Disorders Identification Test (DUDIT)	Baseline	11 items for measuring participants' drug consumption and drug-related problems.
Generalized Anxiety Disorder-7 (GAD-7)	Baseline, 6, 12 and 26 week followups.	7 questions measuring symptoms of anxiety
Treatment questions (7 questions regarding access to other help and support for problematic alcohol use).	Baseline and 26 week followup.	7 questions regarding access to other help and support for problematic alcohol use.
Usability questions regarding the participants' experience of using the web-app they were assigned.	26 week followup	Questions regarding the participants' experience of using the web-app they were assigned.
Daily Drinking Questionnaire (DDQ)	Baseline, 6, 12 and 26 week followups.	The number of standard glasses (12g of ethanol) consumed and over how many hours for each day of a typical week the last month.
Alcohol Use Disorders Identification Test (AUDIT)	Baseline and 26-week followup.	10 questions measuring alcohol consumption and alcohol-related problems.
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)	Baseline, 6- and 12-week followups.	Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.
Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)	Baseline, 6, 12 and 26 week followups.	9 questions measuring symptoms of depression
Readiness Ruler	Baseline and 26-week followup.	A visual analogue scale measuring participants' motivation to change their alcohol consumption.
DSM-5 Alcohol use disorder criteria.	Baseline	Criteria for the diagnosis Alcohol use disorder in the the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Alcohol Abstinence Self Efficacy scale (AASE)	Baseline, 6, 12 and 26 week followups.	12 items for measuring self efficacy in the domain of abstaining from drinking alcohol.

Trial Locations

Locations (1)

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research; 🇸🇪 Stockholm, Sweden