Skills-training for Reducing Risky Alcohol Use in App Form

NCT03696888 | Completed

• 1 other identifier: 2016/1088-31
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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 between screening measure and 26-week followup

Secondary Outcomes (12)

• Daily Drinking Questionnaire (DDQ)

  Baseline, 6, 12 and 26 week followups.

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline and 26-week followup.

• Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)

  Baseline, 6- and 12-week followups.

• Readiness Ruler

  Baseline and 26-week followup.

• DSM-5 Alcohol use disorder criteria.

  Baseline

Study Arms (2)

Telecoach

EXPERIMENTAL

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

Behavioral: Telecoach

TeleCoach control

ACTIVE COMPARATOR

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

Behavioral: TeleCoach control

Interventions

Telecoach BEHAVIORAL

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

Telecoach

TeleCoach control BEHAVIORAL

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

TeleCoach control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, 11364, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32536880 DERIVED

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Alzheimer Disease; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Anne H Berman, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: December 7, 2018
• Primary Completion: January 15, 2020
• Study Completion: August 15, 2020
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

SE (1)