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

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03116282
Collaborator
TRYG Foundation (Other), Novavi Outpatient Clinics (Other)
365
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2
42.3
8.6

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Behavioral: E-alcohol therapy
N/A

Detailed Description

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:
  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
365 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference
Actual Study Start Date :
Jan 20, 2018
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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
Conversational therapy sessions provided via video conference by a professional alcohol therapist.
Other Names:
  • Electronic alcohol therapy
  • No Intervention: Control

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Initiation of treatment (completion of one session) [3 months post randomization]

      25% higher completion of one treatment session

    2. Initiation of treatment (completion of one session) [12 months post randomization]

      25% higher completion of at least one treatment sessions

    3. Compliance (completion of at least 3 sessions) [3 months post randomization]

      25% higher completion of at least three treatment sessions

    4. Compliance (completion of at least 3 sessions) [12 months post randomization]

      25% higher completion of at least three treatment sessions

    5. Total weekly alcohol intake (measured by Timeline follow back) [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) [12 months post randomization]

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

    Secondary Outcome Measures

    1. Weekly alcohol intake below national guidelines [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 [3 and 12 months post randomization]

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

    3. Weekly drinking days [3 and 12 months post randomization]

      Lower number of weekly drinking days

    4. Problematic drinking [12 months post randomization]

      Lower Alcohol Use Disorder Test score

    5. Quality of life [3 and 12 months post randomization]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Public Health Copenhagen Denmark 1455

    Sponsors and Collaborators

    • University of Southern Denmark
    • TRYG Foundation
    • Novavi Outpatient Clinics

    Investigators

    • Study Director: Janne Tolstrup, Professor, University of Southern Denmark
    • Study Director: Ulrik Becker, Professor, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kia Kejlskov Egan, PhD student, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT03116282
    Other Study ID Numbers:
    • 63110-2179
    First Posted:
    Apr 17, 2017
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021