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Completed

NCT Number: NCT03116282

E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference

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 .

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Public Health

Copenhagen, 1455, Denmark

About this study

Background: Only a small proportion of those who have a problematic alcohol use receive treatment and compliance is low among the few that undergo treatment. If treatment more easily can be combined with everyday life and break with some of the barriers related to stigma by having a broader appeal, more people with a problematic alcohol use may seek and complete treatment. Alcohol therapy conducted via video conference may be an attractive treatment option and effective in reducing alcohol intake among people with a problematic alcohol use who do not seek traditional treatment.

Objective: The aim of this trial is to evaluate whether people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8), who enroll in alcohol therapy delivered via video conference to a greater extent initiate as well as comply with treatment and reduce their alcohol intake compared to people allocated to standard alcohol treatment.

Design: Randomized controlled trial

Participants: 375 Danish citizens above 18 years with a problematic alcohol use (Alcohol Use Disorder Test (AUDIT) score >8).

Intervention: Participants are randomized to one of two groups:

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

The allocation of participants to the intervention will be 1:1 to the intervention and the control group.

Methods: Data will be collected by questionnaire at baseline, 3 months and 12 months post randomization. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics.

Process evaluation will be performed using a combination of questionnaires and qualitative interviews with participants, therapists and management at the clinics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

E-alcohol therapy

Behavioral

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

Other names: Electronic alcohol therapy

Primary outcomes

  1. Initiation of treatment (completion of one session)

    Time frame: 3 months post randomization

    25% higher completion of one treatment session

  2. Initiation of treatment (completion of one session)

    Time frame: 12 months post randomization

    25% higher completion of at least one treatment sessions

  3. Compliance (completion of at least 3 sessions)

    Time frame: 3 months post randomization

    25% higher completion of at least three treatment sessions

  4. Compliance (completion of at least 3 sessions)

    Time frame: 12 months post randomization

    25% higher completion of at least three treatment sessions

  5. Total weekly alcohol intake (measured by Timeline follow back)

    Time frame: 3 months post randomization

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

  6. Total weekly alcohol intake (measured by Timeline follow back)

    Time frame: 12 months post randomization

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

Secondary outcomes

  1. Weekly alcohol intake below national guidelines

    Time frame: 3 and 12 months post randomization

    20% increase in participants reporting a weekly alcohol intake below the national high risk drinking limits.

  2. Weekly number of heavy drinking days

    Time frame: 3 and 12 months post randomization

    Lower number of weekly heavy drinking days (5+ units in one occasion)

  3. Weekly drinking days

    Time frame: 3 and 12 months post randomization

    Lower number of weekly drinking days

  4. Problematic drinking

    Time frame: 12 months post randomization

    Lower Alcohol Use Disorder Test score

  5. Quality of life

    Time frame: 3 and 12 months post randomization

    Higher quality of life as measured by the 'Cantril Ladder'

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Novavi Outpatient Clinics
  • TRYG Foundation

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2017
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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