Skills-training for Reducing Risky Alcohol Use in App Form

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2020-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Two Consecutive Randomized Controlled Trials Using Mobile Phone Applications for Risky Alcohol Use

NCT02064998

Binge Drinking Problematic AOD Use

COMPLETED NA

Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use

NCT05037630

Alcohol Consumption

COMPLETED NA

Self-Selected Brief Alcohol Intervention for Adolescents

NCT00383838

Alcohol Consumption Drug Abuse

COMPLETED NA

The Efficacy of the Alcooquizz App to Reduce Hazardous Alcohol Consumption

NCT03008928

Alcohol Consumption

COMPLETED NA

Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial

NCT01958359

Problem Drinking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telecoach

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

Group Type EXPERIMENTAL

Telecoach

Intervention Type BEHAVIORAL

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

TeleCoach control

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

Group Type ACTIVE_COMPARATOR

TeleCoach control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telecoach

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

Intervention Type BEHAVIORAL

TeleCoach control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No