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

Alcohol; Harmful Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116282
• Other study ID #: 63110-2179
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol; Harmful Use

Intervention

Behavioral:
• E-alcohol therapy
Conversational therapy sessions provided via video conference by a professional alcohol therapist.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Novavi Outpatient Clinics, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of treatment (completion of one session)	25% higher completion of one treatment session	3 months post randomization
Primary	Initiation of treatment (completion of one session)	25% higher completion of at least one treatment sessions	12 months post randomization
Primary	Compliance (completion of at least 3 sessions)	25% higher completion of at least three treatment sessions	3 months post randomization
Primary	Compliance (completion of at least 3 sessions)	25% higher completion of at least three treatment sessions	12 months post randomization
Primary	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
Primary	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	Weekly alcohol intake below national guidelines	20% increase in participants reporting a weekly alcohol intake below the national high risk drinking limits.	3 and 12 months post randomization
Secondary	Weekly number of heavy drinking days	Lower number of weekly heavy drinking days (5+ units in one occasion)	3 and 12 months post randomization
Secondary	Weekly drinking days	Lower number of weekly drinking days	3 and 12 months post randomization
Secondary	Problematic drinking	Lower Alcohol Use Disorder Test score	12 months post randomization
Secondary	Quality of life	Higher quality of life as measured by the 'Cantril Ladder'	3 and 12 months post randomization