Skills-training for Reducing Risky Alcohol Use in App Form

Alcohol Use Disorder Clinical Trial

Official title:

Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696888
• Other study ID #: 2016/1088-31
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: August 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol; Harmful Use
• Alcoholism

Intervention

Behavioral:
• Telecoach
A skills-training web-app teaching skills for reducing problematic alcohol use.
• TeleCoach control
A web-app providing information about the health-related consequences of alcohol consumption.

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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