Problematic Alcohol UseNCT03116282
E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference
A study testing E-alcohol therapy in people with Problematic Alcohol Use, run by University of Southern Denmark at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Problematic Alcohol Use
- What is being tested?
- E-alcohol therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jan 2018to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read the 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:
- 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.
- Conditions
- Problematic Alcohol Use
- Being tested
- E-alcohol therapy
- Keywords
- e-alcohol therapy, online alcohol treatment, internet-based alcohol treatment, alcohol intervention, video therapy, proactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-alcohol therapyBehavioural
Also called Electronic alcohol therapy
Conversational therapy sessions provided via video conference by a professional alcohol therapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: E-alcohol therapy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of treatment (completion of one session)
25% higher completion of one treatment session
Measured: 3 months post randomization
Initiation of treatment (completion of one session)
25% higher completion of at least one treatment sessions
Measured: 12 months post randomization
Compliance (completion of at least 3 sessions)
25% higher completion of at least three treatment sessions
Measured: 3 months post randomization
Compliance (completion of at least 3 sessions)
25% higher completion of at least three treatment sessions
Measured: 12 months post randomization
Total weekly alcohol intake (measured by Timeline follow back)
Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)
Measured: 3 months post randomization
Total weekly alcohol intake (measured by Timeline follow back)
Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)
Measured: 12 months post randomization
Secondary outcomes (5)
Weekly alcohol intake below national guidelines
20% increase in participants reporting a weekly alcohol intake below the national high risk drinking limits.
Measured: 3 and 12 months post randomization
Weekly number of heavy drinking days
Lower number of weekly heavy drinking days (5+ units in one occasion)
Measured: 3 and 12 months post randomization
Weekly drinking days
Lower number of weekly drinking days
Measured: 3 and 12 months post randomization
Problematic drinking
Lower Alcohol Use Disorder Test score
Measured: 12 months post randomization
Quality of life
Higher quality of life as measured by the 'Cantril Ladder'
Measured: 3 and 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start22 Jan 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problematic Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Novavi Outpatient Clinics
- Responsible party
- Principal investigator, Kia Kejlskov Egan, University of Southern Denmark
- Investigators
- Janne Tolstrup, Professor, Study director, University of Southern DenmarkUlrik Becker, Professor, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116282
- Sponsor's protocol ID
- 63110-2179
- Status last verified
- Nov 2024
- First submitted
- 29 Mar 2017
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egan KK, Becker U, M Ller SP, Pisinger V, Tolstrup JS. Effectiveness of proactive video therapy for problematic alcohol use on treatment initiation, compliance, and alcohol intake: a randomised controlled trial in Denmark. Lancet Digit Health. 2024 Jun;6(6):e418-e427. doi: 10.1016/S2589-7500(24)00067-0.
PubMed 38789142
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference
- ClinicalTrials.gov ID
- NCT03116282
- Acronym / sponsor ID
- 63110-2179
- Conditions
- Problematic Alcohol Use
- Keywords
- e-alcohol therapy, online alcohol treatment, internet-based alcohol treatment, alcohol intervention, video therapy, proactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TRYG Foundation, Novavi Outpatient Clinics
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: E-alcohol therapyConversational 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-alcohol therapyAlso: Electronic alcohol therapyConversational therapy sessions provided via video conference by a professional alcohol therapist. | Behavioural | Intervention |
Primary outcome
Initiation of treatment (completion of one session)
Time frame: 3 months post randomization
25% higher completion of one treatment session
Initiation of treatment (completion of one session)
Time frame: 12 months post randomization
25% higher completion of at least one treatment sessions
Compliance (completion of at least 3 sessions)
Time frame: 3 months post randomization
25% higher completion of at least three treatment sessions
Compliance (completion of at least 3 sessions)
Time frame: 12 months post randomization
25% higher completion of at least three treatment sessions
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)
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)
5 secondary outcomes
Weekly alcohol intake below national guidelines
Time frame: 3 and 12 months post randomization
Weekly number of heavy drinking days
Time frame: 3 and 12 months post randomization
Weekly drinking days
Time frame: 3 and 12 months post randomization
Problematic drinking
Time frame: 12 months post randomization
Quality of life
Time frame: 3 and 12 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 38789142Egan KK, Becker U, M Ller SP, Pisinger V, Tolstrup JS. Effectiveness of proactive video therapy for problematic alcohol use on treatment initiation, compliance, and alcohol intake: a randomised controlled trial in Denmark. Lancet Digit Health. 2024 Jun;6(6):e418-e427. doi: 10.1016/S2589-7500(24)00067-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Tolstrup, Professor study director
University of Southern Denmark
Ulrik Becker, Professor study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-alcohol therapy in people with Problematic Alcohol Use, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of treatment (completion of one session) (time frame: 3 months post randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.