Problematic AOD UsePhase 2NCT01544803
Randomized Controlled Trial of eScreen for Problematic Alcohol Use
A Phase 2 study testing eScreen and Alkoholhjalpen in people with Problematic AOD Use, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Problematic AOD Use
- What is being tested?
- eScreen and Alkoholhjalpen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Oct 2011
- Phase
- Phase 2
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Problematic alcohol use. AUDIT>7 for men and AUDIT>5 for women
Who cannot join
- Drug use DUDIT>0
- Unproblematic alcohol use, AUDIT<8 for men and AUDIT<6 for women
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Clinical Neuroscience
Stockholm, 17176
About this study
Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. A more extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.
Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis is that there will be no differences between participants in the eScreen and the Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. For a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.
- Conditions
- Problematic AOD Use
- Being tested
- eScreen, Alkoholhjalpen
- Keywords
- Randomized Controlled Trial, Alcohol, Internet, Screening, Brief intervention, Personalized feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eScreenBehavioural
Also called www.escreen.se
The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.
AlkoholhjalpenBehavioural
Also called www.alkoholhjalpen.se
An extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Web based self-monitoring | Experimental | Not described Receives: Behavioral: eScreen |
| Web based self-help | Active comparator | Not described Receives: Behavioral: Alkoholhjalpen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total AUDIT-C score
The primary outcome measure for this trial was the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
Measured: 3, 6 and 12 months
Secondary outcomes (1)
AUDIT
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Problematic AOD UseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Anne H Berman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544803
- Sponsor's protocol ID
- 2008/308-31/5A
- Status last verified
- Mar 2025
- First submitted
- 27 Oct 2011
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinadinovic K, Berman AH, Hasson D, Wennberg P. Internet-based assessment and self-monitoring of problematic alcohol and drug use. Addict Behav. 2010 May;35(5):464-70. doi: 10.1016/j.addbeh.2009.12.021. Epub 2010 Jan 4.
PubMed 20092953Sinadinovic K, Wennberg P, Berman AH. Population screening of risky alcohol and drug use via Internet and Interactive Voice Response (IVR): a feasibility and psychometric study in a random sample. Drug Alcohol Depend. 2011 Mar 1;114(1):55-60. doi: 10.1016/j.drugalcdep.2010.09.004. Epub 2010 Oct 27.
PubMed 21030164
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of eScreen for Problematic Alcohol Use
- ClinicalTrials.gov ID
- NCT01544803
- Acronym / sponsor ID
- 2008/308-31/5A
- Conditions
- Problematic AOD Use
- Keywords
- Randomized Controlled Trial, Alcohol, Internet, Screening, Brief intervention, Personalized feedback
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Mar 2012 (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.
Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. A more extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.
Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months.
The first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis is that there will be no differences between participants in the eScreen and the Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. For a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Web based self-monitoring | Experimental | Behavioral: eScreen |
| Web based self-help | Active comparator | Behavioral: Alkoholhjalpen |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Problematic alcohol use. AUDIT>7 for men and AUDIT>5 for women
Key exclusion criteria (2 listed)
- Drug use DUDIT>0
- Unproblematic alcohol use, AUDIT<8 for men and AUDIT<6 for women
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 |
|---|---|---|
| eScreenAlso: www.escreen.seThe eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. | Behavioural | Web based self-monitoring |
| AlkoholhjalpenAlso: www.alkoholhjalpen.seAn extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum. | Behavioural | Web based self-help |
Primary outcome
Change in the total AUDIT-C score
Time frame: 3, 6 and 12 months
The primary outcome measure for this trial was the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
1 secondary outcome
AUDIT
Time frame: 3, 6 and 12 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 17 Mar 2025.
- Background: PubMed 20092953Sinadinovic K, Berman AH, Hasson D, Wennberg P. Internet-based assessment and self-monitoring of problematic alcohol and drug use. Addict Behav. 2010 May;35(5):464-70. doi: 10.1016/j.addbeh.2009.12.021. Epub 2010 Jan 4.
- Background: PubMed 21030164Sinadinovic K, Wennberg P, Berman AH. Population screening of risky alcohol and drug use via Internet and Interactive Voice Response (IVR): a feasibility and psychometric study in a random sample. Drug Alcohol Depend. 2011 Mar 1;114(1):55-60. doi: 10.1016/j.drugalcdep.2010.09.004. Epub 2010 Oct 27.
- For research group profile search BermanLink provided by the sponsor.
- Web based self-monitoring siteLink provided by the sponsor.
- Web based self-help siteLink provided by the sponsor.
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.
Anne H Berman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eScreen and Alkoholhjalpen in people with Problematic AOD Use, run by Karolinska Institutet 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 2 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 17 Mar 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the total AUDIT-C score (time frame: 3, 6 and 12 months). 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 NCT01544803, which also lists 2 linked publications.
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 17 Mar 2025.