NCT03116282

Brief Summary

The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered via video conference) can break with some of the barriers related to alcohol treatment and thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment compliance and alcohol intake as compared to treatment as usual .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

March 29, 2017

Last Update Submit

November 27, 2024

Conditions

Problematic Alcohol Use

Keywords

e-alcohol therapyonline alcohol treatmentinternet-based alcohol treatmentalcohol interventionvideo therapyproactivity

Outcome Measures

Primary Outcomes (6)

  • Initiation of treatment (completion of one session)

    25% higher completion of one treatment session

    3 months post randomization

  • Initiation of treatment (completion of one session)

    25% higher completion of at least one treatment sessions

    12 months post randomization

  • Compliance (completion of at least 3 sessions)

    25% higher completion of at least three treatment sessions

    3 months post randomization

  • Compliance (completion of at least 3 sessions)

    25% higher completion of at least three treatment sessions

    12 months post randomization

  • Total weekly alcohol intake (measured by Timeline follow back)

    Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)

    3 months post randomization

  • Total weekly alcohol intake (measured by Timeline follow back)

    Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)

    12 months post randomization

Secondary Outcomes (5)

  • Weekly alcohol intake below national guidelines

    3 and 12 months post randomization

  • Weekly number of heavy drinking days

    3 and 12 months post randomization

  • Weekly drinking days

    3 and 12 months post randomization

  • Problematic drinking

    12 months post randomization

  • Quality of life

    3 and 12 months post randomization

Study Arms (2)

Intervention

EXPERIMENTAL

Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of therapy where participants are not required to show up at a clinic.

Behavioral: E-alcohol therapy

Control

NO INTERVENTION

Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

Interventions

E-alcohol therapyBEHAVIORAL

Conversational therapy sessions provided via video conference by a professional alcohol therapist.

Also known as: Electronic alcohol therapy
Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)

You may not qualify if:

  • Not legally able and willing to provide informed consent
  • No provision of a functional e-mail address
  • No provision of municipality of residence and phone number
  • No access to a personal computer equipped with functional camera, audio equipment, and Internet access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Public Health

Copenhagen, 1455, Denmark

Location

Related Publications (1)

  • Egan KK, Becker U, M Ller SP, Pisinger V, Tolstrup JS. Effectiveness of proactive video therapy for problematic alcohol use on treatment initiation, compliance, and alcohol intake: a randomised controlled trial in Denmark. Lancet Digit Health. 2024 Jun;6(6):e418-e427. doi: 10.1016/S2589-7500(24)00067-0.

    PMID: 38789142DERIVED

MeSH Terms

Interventions

EthanolTherapeutics

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Janne Tolstrup, Professor

    University of Southern Denmark

    STUDY DIRECTOR

  • Ulrik Becker, Professor

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 17, 2017

Study Start

January 22, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)