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CompletedNCT03696888Updated Nov 13, 2023

Skills-training for Reducing Risky Alcohol Use in App Form

An interventional study of Telecoach and TeleCoach control in Alcohol Abuse, Alcohol Use Disorder and Alcohol Drinking, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
678
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Randomized Controlled Trial
  • Internet
  • Mobile phone
  • Smartphone
  • App
  • Alcohol
  • Substance use
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 678 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
678 participants (actual)

Study arms

  • Experimental
    Telecoach

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

    Behavioral: Telecoach

  • Active comparator
    TeleCoach control

    A web-app giving information on health-related consequences of alcohol consumption.

    Behavioral: TeleCoach control

Interventions

  • BehavioralTelecoach

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

  • BehavioralTeleCoach control

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

06

What researchers measure

Primary outcomes

  1. 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 frame: Time between screening measure and 26-week followup

Secondary outcomes

  1. 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.

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

  2. Alcohol Use Disorders Identification Test (AUDIT)

    10 questions measuring alcohol consumption and alcohol-related problems.

    Time frame: Baseline and 26-week followup.

  3. 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 frame: Baseline, 6- and 12-week followups.

  4. Readiness Ruler

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

    Time frame: Baseline and 26-week followup.

  5. 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)

    Time frame: Baseline

  6. Penn Alcohol Craving Scale (PACS)

    5 items to measure participants' craving for alcohol.

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

  7. Alcohol Abstinence Self Efficacy scale (AASE)

    12 items for measuring self efficacy in the domain of abstaining from drinking alcohol.

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

  8. Drug Use Disorders Identification Test (DUDIT)

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

    Time frame: Baseline

  9. Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)

    9 questions measuring symptoms of depression

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

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

    7 questions measuring symptoms of anxiety

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

  11. 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.

    Time frame: Baseline and 26 week followup.

  12. 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.

    Time frame: 26 week followup

07

Study locations

1 site
  • Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
    Stockholm, 11364, Sweden
08

References and documents

Publications

  • Berman AH, Molander O, Tahir M, Tornblom P, Gajecki M, Sinadinovic K, Andersson C. Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. Front Psychiatry. 2020 May 27;11:434. doi: 10.3389/fpsyt.2020.00434. eCollection 2020. PubMed 32536880 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03696888
Lead sponsor
Karolinska Institutet
Responsible party
Anne H Berman (Associate Professor, Karolinska Institutet) — Principal investigator
First posted
Oct 5, 2018
Start date
Dec 7, 2018
Primary completion
Jan 15, 2020
Completion
Aug 15, 2020
Last update
Nov 13, 2023

Study contacts

Anne H Berman, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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