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Alcohol AbuseNCT03696888

Skills-training for Reducing Risky Alcohol Use in App Form

A study testing Telecoach in people with Alcohol Abuse and Alcohol Use Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telecoach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
678 participants
Where
1 siteSweden
Study dates
7 Dec 2018to 15 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

    Stockholm, 11364

Other trials in Sweden

About this study

Official title: 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.

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.

Being tested
Telecoach, TeleCoach control
Keywords
Randomized Controlled Trial, Internet, Mobile phone, Smartphone, App, Alcohol, Substance use
Medical subject headings
Alcoholism, Alcohol Drinking, Alzheimer Disease, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelecoachBehavioural

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

  • TeleCoach controlBehavioural

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

Study groups in NCT03696888
Study groupRoleWhat they receive
TelecoachExperimentalA skills-training web-app teaching skills for reducing problematic alcohol use.
Receives: Behavioral: Telecoach
TeleCoach controlActive comparatorA web-app giving information on health-related consequences of alcohol consumption.
Receives: Behavioral: TeleCoach control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Time between screening measure and 26-week followup

Secondary outcomes (12)

  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.

    Measured: Baseline, 6, 12 and 26 week followups.

  2. Alcohol Use Disorders Identification Test (AUDIT)

    10 questions measuring alcohol consumption and alcohol-related problems.

    Measured: 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.

    Measured: Baseline, 6- and 12-week followups.

  4. Readiness Ruler

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

    Measured: 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)

    Measured: Baseline

  6. Penn Alcohol Craving Scale (PACS)

    5 items to measure participants' craving for alcohol.

    Measured: 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.

    Measured: 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.

    Measured: Baseline

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

    9 questions measuring symptoms of depression

    Measured: Baseline, 6, 12 and 26 week followups.

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

    7 questions measuring symptoms of anxiety

    Measured: 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.

    Measured: 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.

    Measured: 26 week followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start7 Dec 2018
  3. Primary completion15 Jan 2020
  4. Study completion15 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Note: A pilot period with interim 6-week analyses following recruitment of about 10% of the maximum anticipated sample of 1000 is part of the study. This offers an opportunity to assess trial continuation from an ethical perspective. The rationale for this is that individuals with relatively severe levels of alcohol use can be included in the trial and the investigators harbor a concern that the components in the intervention and control conditions might be insufficient to support the participants in remaining stable or reducing their alcohol intake. The pilot period covers a recruitment period from Dec 7, 2019 to February 15, 2019 (n=89) and includes a 6-week follow-up. The interim analysis from May 1, 2019 indicates group declines in alcohol use over the 6-week follow-up period for both conditions, suggesting that continuation of the trial is warranted. Pilot participants will be included in the final study sample.
Masking
Single blind
Who is masked
Participant
Enrolment
678 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696888
Sponsor's protocol ID
2016/1088-31
Status last verified
Nov 2023
First submitted
2 Oct 2018
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen Y, Berman AH, Andersson C, Blankers M, Molander O. App-based skills training to reduce problem drinking among adult internet help-seekers: a double-blinded randomized controlled trial. Addict Sci Clin Pract. 2026 Mar 31;21(1):33. doi: 10.1186/s13722-026-00663-5.

    PubMed 41918142

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Telecoach in people with Alcohol Abuse and Alcohol Use Disorder, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in alcohol consumption according to the 7-day Timeline Followback (TLFB) (time frame: Time between screening measure and 26-week followup). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696888, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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