Clinical trial NCT03696888: Skills-training for Reducing Risky Alcohol Use in App Form
Official title: Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Use Disorder
Alcohol Drinking
Alcohol Dependence
Alcohol; Harmful Use
Keywords: Randomized Controlled Trial
Internet
Mobile phone
Smartphone
App
Alcohol
Substance use
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
timeFrame: Time between screening measure and 26-week followup
Secondary outcomes:
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: Baseline, 6, 12 and 26 week followups.
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline and 26-week followup.
measure: Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
timeFrame: Baseline, 6- and 12-week followups.
measure: Readiness Ruler
timeFrame: Baseline and 26-week followup.
measure: DSM-5 Alcohol use disorder criteria.
timeFrame: Baseline
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: Baseline, 6, 12 and 26 week followups.
measure: Alcohol Abstinence Self Efficacy scale (AASE)
timeFrame: Baseline, 6, 12 and 26 week followups.
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline
measure: Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)
timeFrame: Baseline, 6, 12 and 26 week followups.
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 6, 12 and 26 week followups.
measure: Treatment questions (7 questions regarding access to other help and support for problematic alcohol use).
timeFrame: Baseline and 26 week followup.
measure: Usability questions regarding the participants' experience of using the web-app they were assigned.
timeFrame: 26 week followup
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.