Skills-training for Reducing Risky Alcohol Use in App Form

September 1, 2020 updated by: Anne H Berman, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

678

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11364
        • Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telecoach
A skills-training web-app teaching skills for reducing problematic alcohol use.
Behavioral: Telecoach
A skills-training web-app teaching skills for reducing problematic alcohol use.
Active Comparator: TeleCoach control
A web-app giving information on health-related consequences of alcohol consumption.
Behavioral: TeleCoach control
A web-app providing information about the health-related consequences of alcohol consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
Time Frame: 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.
Time between screening measure and 26-week followup

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1088-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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