Alcohol ConsumptionNCT01923246
Development of IVR and WEB Alcohol Interventions
A study testing Single WEB intervention, Repeated WEB intervention and Single IVR intervention in people with Alcohol Consumption, run by Region Skane at 1 site in Sweden.
Trial summary
The primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Single WEB intervention, Repeated WEB intervention and Single IVR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,672 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Oct 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Females scoring 6 and above and males scoring 8 and above on AUDIT.
Who cannot join
- Females scoring 5 and below and males scoring 7 and below on AUDIT
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Malmö university, Department of Criminology
Malmö, Skåne County, 20506
About this study
The primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect between single and repeated interventions.
- Conditions
- Alcohol Consumption
- Being tested
- Single WEB intervention, Repeated WEB intervention, Single IVR intervention, Repeated IVR intervention
- Keywords
- Alcohol consumption, Brief intervention, Automated techniques
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single WEB interventionBehavioural
Brief WEB intervention recieved once
Repeated WEB interventionBehavioural
WEB intervention recieved twice.
Single IVR interventionBehavioural
IVR intervention recieved once
Repeated IVR interventionBehavioural
IVR intervention recieved twice
| Study group | Role | What they receive |
|---|---|---|
| Single WEB intervention | Experimental | Web intervention recieved once. Receives: Behavioral: Single WEB intervention |
| Repeated WEB intervention | Experimental | Web intervention recieved twice. Receives: Behavioral: Repeated WEB intervention |
| Single IVR intervention | Experimental | IVR intervention recieved once Receives: Behavioral: Single IVR intervention |
| Repeated IVR intervention | Experimental | IVR intervention recieved twice Receives: Behavioral: Repeated IVR intervention |
| Control group | No intervention | Untreated Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALCOHOL USE DISORDERS IDENTIFICATION TEST (AUDIT)
Measured: September 2011 - October 2011
Secondary outcomes (1)
Daily Drinking Questionnaire (DDQ)
Measured: September 2011 - October 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claes Andersson, Region Skane
- Investigators
- Claes Andersson, PhD, Principal investigator, Malmö University, Department of Criminology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923246
- Sponsor's protocol ID
- FHI 2006/100
- Other IDs
- 2006/100
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of IVR and WEB Alcohol Interventions
- ClinicalTrials.gov ID
- NCT01923246
- Acronym / sponsor ID
- FHI 2006/100
- Conditions
- Alcohol Consumption
- Keywords
- Alcohol consumption, Brief intervention, Automated techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,672 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Aug 2013 (estimated)
- 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 primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect between single and repeated interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single WEB intervention | Experimental | Behavioral: Single WEB interventionWeb intervention recieved once. |
| Repeated WEB intervention | Experimental | Behavioral: Repeated WEB interventionWeb intervention recieved twice. |
| Single IVR intervention | Experimental | Behavioral: Single IVR interventionIVR intervention recieved once |
| Repeated IVR intervention | Experimental | Behavioral: Repeated IVR interventionIVR intervention recieved twice |
| Control group | No intervention | –Untreated Control Group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Females scoring 6 and above and males scoring 8 and above on AUDIT.
Key exclusion criteria (1 listed)
- Females scoring 5 and below and males scoring 7 and below on AUDIT
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 |
|---|---|---|
| Single WEB interventionBrief WEB intervention recieved once | Behavioural | Single WEB intervention |
| Repeated WEB interventionWEB intervention recieved twice. | Behavioural | Repeated WEB intervention |
| Single IVR interventionIVR intervention recieved once | Behavioural | Single IVR intervention |
| Repeated IVR interventionIVR intervention recieved twice | Behavioural | Repeated IVR intervention |
Primary outcome
ALCOHOL USE DISORDERS IDENTIFICATION TEST (AUDIT)
Time frame: September 2011 - October 2011
1 secondary outcome
Daily Drinking Questionnaire (DDQ)
Time frame: September 2011 - October 2011
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 15 Aug 2013.
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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.
Claes Andersson, PhD principal investigator
Malmö University, Department of Criminology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single WEB intervention, Repeated WEB intervention and Single IVR intervention in people with Alcohol Consumption, run by Region Skane at 1 site in Sweden.
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 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 15 Aug 2013. 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 Sweden. 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?
ALCOHOL USE DISORDERS IDENTIFICATION TEST (AUDIT) (time frame: September 2011 - October 2011). 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 15 Aug 2013.