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Completed

NCT Number: NCT03696888

Skills-training for Reducing Risky Alcohol Use in App Form

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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Key information

Conditions

Alcohol Abuse Alcohol Dependence Alcohol Drinking Alcohol Use Disorder Alcohol-Related Disorders Alcohol; Harmful Use Alcoholism Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Dementia Drinking Behavior Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Substance-Related Disorders Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Stockholm, 11364, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telecoach

Behavioral

A skills-training web-app teaching skills for reducing problematic alcohol use.

TeleCoach control

Behavioral

A web-app providing information about the health-related consequences of alcohol consumption.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Baseline and 26-week followup.

    10 questions measuring alcohol consumption and alcohol-related problems.

  3. 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.

  4. Readiness Ruler

    Time frame: Baseline and 26-week followup.

    A visual analogue scale measuring participants' motivation to change their alcohol consumption.

  5. 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)

  6. Penn Alcohol Craving Scale (PACS)

    Time frame: Baseline, 6, 12 and 26 week followups.

    5 items to measure participants' craving for alcohol.

  7. 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.

  8. Drug Use Disorders Identification Test (DUDIT)

    Time frame: Baseline

    11 items for measuring participants' drug consumption and drug-related problems.

  9. 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

  10. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, 6, 12 and 26 week followups.

    7 questions measuring symptoms of anxiety

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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