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Clinical Trials/NCT03116282
NCT03116282
Completed
Not Applicable

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

University of Southern Denmark1 site in 1 country365 target enrollmentJanuary 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Problematic Alcohol Use
Sponsor
University of Southern Denmark
Enrollment
365
Locations
1
Primary Endpoint
Compliance (completion of at least 3 sessions)
Status
Completed
Last Updated
last year

Overview

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 .

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2018
End Date
August 1, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kia Kejlskov Egan

PhD student

University of Southern Denmark

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Compliance (completion of at least 3 sessions)

Time Frame: 12 months post randomization

25% higher completion of at least three treatment sessions

Initiation of treatment (completion of one session)

Time Frame: 12 months post randomization

25% higher completion of at least one treatment sessions

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

  • Weekly drinking days(3 and 12 months post randomization)
  • Quality of life(3 and 12 months post randomization)
  • Weekly number of heavy drinking days(3 and 12 months post randomization)
  • Weekly alcohol intake below national guidelines(3 and 12 months post randomization)
  • Problematic drinking(12 months post randomization)

Study Sites (1)

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