Alcohol ProblemNCT03601793
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
A study testing Alcohol Help Center and Assistance from a health educator in people with Alcohol Problem, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcohol Problem
- What is being tested?
- Alcohol Help Center and Assistance from a health educator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 19 Jun 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
- A preceding week alcohol consumption of 14 standard drinks or more
Who cannot join
- Being under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial
The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.
Read the detailed description
This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).
The Investigators hypothesize that
- participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC
- participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
- engagement with the intervention will mediate any effects on drinking behavior.
A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).
- Conditions
- Alcohol Problem
- Being tested
- Alcohol Help Center, Assistance from a health educator
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Help CenterBehavioural
An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems
Assistance from a health educatorBehavioural
This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks
| Study group | Role | What they receive |
|---|---|---|
| Internet intervention with assistance | Experimental | This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization. Receives: Behavioral: Alcohol Help Center; Behavioral: Assistance from a health educator |
| Internet intervention without assistance | Active comparator | This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator. Receives: Behavioral: Alcohol Help Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks preceding week
Change in the number of standard drinks consumed during preceding week from baseline
Measured: 3 and 6 months
Heavy drinking days preceding week
Change in the number of heavy drinking days during preceding week from baseline
Measured: 3 and 6 months
Secondary outcomes (5)
Alcohol Use Disorders Identification Test (AUDIT)
Assessment of alcohol problems
Measured: Baseline, 3 month follow up, 6 month follow up
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Assessment of alcohol consumption (the first 3 items in AUDIT)
Measured: Baseline, 3 month follow up, 6 month follow up
EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)
Instrument measuring five health-related quality of life dimensions. Each dimension has five levels ranging from no problems to extreme problems. The dimensions can be combined into an index value between 0 (lowest) and 1 (highest). In addition to the five dimensions, a visual analogue scale item allows participants to measure health outcomes that reflect the participant's judgement. Endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).
Measured: Baseline, 3 month follow up, 6 month follow up
DSM criteria
The 11 DSM criteria of alcohol use disorders (yes/no)
Measured: Baseline
Previously received treatment or help for alcohol concerns
Questions about what kind of treatment or help for alcohol concerns the participant has received previously
Measured: Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ProblemStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601793
- Sponsor's protocol ID
- 029/2018
- Status last verified
- Jun 2019
- First submitted
- 16 Jul 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03601793
- Acronym / sponsor ID
- 029/2018
- Conditions
- Alcohol Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 26 Jul 2018 (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 purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.
Detailed description
This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).
The Investigators hypothesize that
- participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC
- participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
- engagement with the intervention will mediate any effects on drinking behavior.
A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet intervention with assistance | Experimental | Behavioral: Alcohol Help Center, Behavioral: Assistance from a health educatorThis arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization. |
| Internet intervention without assistance | Active comparator | Behavioral: Alcohol Help CenterThis arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
- A preceding week alcohol consumption of 14 standard drinks or more
Key exclusion criteria (1 listed)
- Being under 18 years of age
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 |
|---|---|---|
| Alcohol Help CenterAn internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems | Behavioural | Internet intervention with assistance, Internet intervention without assistance |
| Assistance from a health educatorThis entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks | Behavioural | Internet intervention with assistance |
Primary outcome
Drinks preceding week
Time frame: 3 and 6 months
Change in the number of standard drinks consumed during preceding week from baseline
Heavy drinking days preceding week
Time frame: 3 and 6 months
Change in the number of heavy drinking days during preceding week from baseline
5 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline, 3 month follow up, 6 month follow up
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Time frame: Baseline, 3 month follow up, 6 month follow up
EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)
Time frame: Baseline, 3 month follow up, 6 month follow up
DSM criteria
Time frame: Baseline
Previously received treatment or help for alcohol concerns
Time frame: Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months)
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 25 Jun 2019.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- 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.
John A Cunningham, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Help Center and Assistance from a health educator in people with Alcohol Problem, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 2 inclusion and 1 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 25 Jun 2019. 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 Canada. 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?
Drinks preceding week (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.