Clinical trial NCT03116282: E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference
Official title: E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problematic Alcohol Use
Keywords: e-alcohol therapy
online alcohol treatment
internet-based alcohol treatment
alcohol intervention
video therapy
proactivity
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
name: Novavi Outpatient Clinics
First posted: 2017-04-17
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Initiation of treatment (completion of one session)
timeFrame: 3 months post randomization
measure: Initiation of treatment (completion of one session)
timeFrame: 12 months post randomization
measure: Compliance (completion of at least 3 sessions)
timeFrame: 3 months post randomization
measure: Compliance (completion of at least 3 sessions)
timeFrame: 12 months post randomization
measure: Total weekly alcohol intake (measured by Timeline follow back)
timeFrame: 3 months post randomization
measure: Total weekly alcohol intake (measured by Timeline follow back)
timeFrame: 12 months post randomization
Secondary outcomes:
measure: Weekly alcohol intake below national guidelines
timeFrame: 3 and 12 months post randomization
measure: Weekly number of heavy drinking days
timeFrame: 3 and 12 months post randomization
measure: Weekly drinking days
timeFrame: 3 and 12 months post randomization
measure: Problematic drinking
timeFrame: 12 months post randomization
measure: Quality of life
timeFrame: 3 and 12 months post randomization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health
Study officials:
affiliation: University of Southern Denmark
name: Janne Tolstrup, Professor
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark
name: Ulrik Becker, Professor
role: STUDY_DIRECTOR
References: