Problematic AOD UseNCT01532388

Randomized Controlled Trial of eScreen for Problematic Drug Use

A study testing eScreen in people with Problematic AOD Use, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 99 years
Conditions the study is for: Problematic AOD Use
What is being tested?: eScreen
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 1 siteSweden
Study dates: Sep 2009to May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

DUDIT >0

Who cannot join

DUDIT = 0

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska institutet, Department of Clinical Neurosciene
Stockholm, 17176

Other trials in Sweden

About this study

Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic drug 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.

Method: Participants with only problematic drug use according to the Drug Use Disorders Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men and AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group (n=101). Outcomes on alcohol and/or drug use as well as health-related symptoms were assessed after 3, 6 and 12 months.

Hypotheses that were tested in this study are 1) that both groups would reduce their drug consumption and drug-related problems at follow-ups compared to the baseline level and 2) that participants in the eScreen group would reduce their drug consumption and drug-related problems to a higher extent than participants in the control group (no intervention) at follow-ups.

Read the detailed description

Background: The aim of this study is to investigate the effects of an Internet-based screening and brief intervention (SBI) site for problematic alcohol and drug use among illicit drug users.

Method: Individuals searching for information about alcohol or drugs online who scored over 0 on the Drug Use Disorders Identiﬁcation Test (DUDIT) and were 15 years or older were recruited for this trial and randomized into one group receiving Internet-based screening and brief intervention via eScreen.se(n = 101) or one assessment-only control group (n = 101). Both groups were screened at baseline and followed up at 3 and 6 months. The primary outcome measure was the DUDIT-C score and secondary outcome measures were DUDIT, AUDIT-C (Alcohol Use Disorders Identiﬁcation Test-C) and AUDIT scores.Additional outcomes included the proportion of drug abstainers and those who made a clinically signiﬁcant change in their alcohol and drug use. Four statistical models of analysis were used to conservatively assess results.

Conditions: Problematic AOD Use
Being tested: eScreen
Keywords: Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eScreenBehavioural
Web based self-monitoring of problematic alcohol and drug use.

Study groups in NCT01532388
Study group	Role	What they receive
eScreen	Experimental	Web based self-monitoring of problematic alcohol and drug use. Receives: Behavioral: eScreen
Control group	No intervention	Untreated control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Drug Use Disorders Identification Test-Consumption (DUDIT-C)
The primary outcome measure for this trial was the total DUDIT score for the first four DUDIT questions at 3-month follow-up, as a measure of drug consumption only, referred to as the DUDIT-C.The DUDIT-C is a measure including the first four items of the DUDIT, with a minimum score of 0 and a maximum score of 16. Higher scores mean a worse outcome. Regarding the DUDIT-C, you will find information on it in the following articles. Please note that the analyses all refer to the same sample from a randomized controlled trial. Apart from the data in the two articles describing results from the current study, there are additional analyses shown in:
Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi: 10.1037/a0038420 A higher score means a worse outcome.
Measured: 3 months

Secondary outcomes (11)

Drug Use Disorders Identification Test (DUDIT)
The total DUDIT score at 3-month follow-up, as a summarized measure of drug use (including drug consumption and drug-related problems). The DUDIT, an 11-item scale, has a minimum score of 0 and a maximum score of 44. Higher scores mean a worse outcome.
Measured: 3 months
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
The total AUDIT score for the first three AUDIT questions at 3-month follow-up, as a measure of alcohol consumption only, referred to as the AUDIT-C. The AUDIT-C, a 3-item scale, has a minimum score of 0 and a maximum score of 12. Higher scores mean a worse outcome.
Measured: 3 months
Alcohol Use Disorders Identification Test - AUDIT
The total AUDIT score at 3-month follow-up, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems). The AUDIT, an 10-item scale, has a minimum score of 0 and a maximum score of 40. Higher scores mean a worse outcome.
Measured: 3 months
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
The total DUDIT score for the first four DUDIT questions at 6-month follow-up, as a measure of drug consumption only, referred to as the DUDIT-C.The DUDIT-C is a measure including the first four items of the DUDIT, with a minimum score of 0 and a maximum score of 16. Higher scores mean a worse outcome.
Measured: 6 months
Drug Use Disorders Identification Test (DUDIT)
The total DUDIT score at 6-month follow-up, as a summarized measure of drug use (including drug consumption and drug-related problems). The DUDIT, an 11-item scale, has a minimum score of 0 and a maximum score of 44. Higher scores mean a worse outcome.
Measured: 6 months
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
The total AUDIT score for the first three AUDIT questions at 6-month follow-up, as a measure of alcohol consumption only, referred to as the AUDIT-C. The AUDIT-C, a 3-item scale, has a minimum score of 0 and a maximum score of 12. Higher scores mean a worse outcome.
Measured: 6 months
Alcohol Use Disorders Identification Test (AUDIT)
The total AUDIT score at 6-month follow-up, as a summarized measure of drug use (including alcohol consumption and alcohol-related problems). The AUDIT, an 10-item scale, has a minimum score of 0 and a maximum score of 40. Higher scores mean a worse outcome.
Measured: 6 months
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
The total DUDIT score for the first four DUDIT questions at 12-month follow-up, as a measure of drug consumption only, referred to as the DUDIT-C.The DUDIT-C is a measure including the first four items of the DUDIT, with a minimum score of 0 and a maximum score of 16. Higher scores mean a worse outcome.
Measured: 12 months
Drug Use Disorders Identification Test (DUDIT)
The total DUDIT score at 12-month follow-up, as a summarized measure of drug use (including drug consumption and drug-related problems). The DUDIT, an 11-item scale, has a minimum score of 0 and a maximum score of 44. Higher scores mean a worse outcome.
Measured: 12 months
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
The total AUDIT score for the first three AUDIT questions at 12-month follow-up, as a measure of alcohol consumption only, referred to as the AUDIT-C. The AUDIT-C, a 3-item scale, has a minimum score of 0 and a maximum score of 12. Higher scores mean a worse outcome.
Measured: 12 months
Alcohol Use Disorders Identification Test (AUDIT)
The total AUDIT score at 12-month follow-up, as a summarized measure of drug use (including alcohol consumption and alcohol-related problems). The AUDIT, an 10-item scale, has a minimum score of 0 and a maximum score of 40. Higher scores mean a worse outcome.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2012

First posted14 Feb 2012 (estimated)
Study startSep 2009
Primary completionApr 2011
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532388
Sponsor's protocol ID: 2008/308-31/5D
Status last verified: Nov 2023
First submitted: 27 Oct 2011
Last updated: 13 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
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 20092953
Sinadinovic 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
Sinadinovic K, Wennberg P, Berman AH. Targeting problematic users of illicit drugs with Internet-based screening and brief intervention: a randomized controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):42-50. doi: 10.1016/j.drugalcdep.2012.04.016. Epub 2012 May 20.
PubMed 22613182
Sinadinovic K, Wennberg P, Berman AH. Internet-based screening and brief intervention for illicit drug users: a randomized controlled trial with 12-month follow-up. J Stud Alcohol Drugs. 2014 Mar;75(2):313-8. doi: 10.15288/jsad.2014.75.313.
PubMed 24650825

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of eScreen for Problematic Drug Use
ClinicalTrials.gov ID: NCT01532388
Acronym / sponsor ID: 2008/308-31/5D
Conditions: Problematic AOD Use
Keywords: Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: Sep 2009
Primary completion: Apr 2011 (actual)
Study completion: May 2012 (actual)
First posted: 14 Feb 2012 (estimated)
Results: Posted 29 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background: The aim of this study is to investigate the effects of an Internet-based screening and brief intervention (SBI) site for problematic alcohol and drug use among illicit drug users.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
eScreen	Experimental	Behavioral: eScreenWeb based self-monitoring of problematic alcohol and drug use.
Control group	No intervention	–Untreated control group

Who may qualify

Ages: 15 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

DUDIT >0

Key exclusion criteria (1 listed)

DUDIT = 0

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
eScreenWeb based self-monitoring of problematic alcohol and drug use.	Behavioural	eScreen

Primary outcome

Drug Use Disorders Identification Test-Consumption (DUDIT-C)
Time frame: 3 months
The primary outcome measure for this trial was the total DUDIT score for the first four DUDIT questions at 3-month follow-up, as a measure of drug consumption only, referred to as the DUDIT-C.The DUDIT-C is a measure including the first four items of the DUDIT, with a minimum score of 0 and a maximum score of 16. Higher scores mean a worse outcome. Regarding the DUDIT-C, you will find information on it in the following articles. Please note that the analyses all refer to the same sample from a randomized controlled trial. Apart from the data in the two articles describing results from the current study, there are additional analyses shown in: Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi: 10.1037/a0038420 A higher score means a worse outcome.

11 secondary outcomes

Drug Use Disorders Identification Test (DUDIT)
Time frame: 3 months
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Time frame: 3 months
Alcohol Use Disorders Identification Test - AUDIT
Time frame: 3 months
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
Time frame: 6 months
Drug Use Disorders Identification Test (DUDIT)
Time frame: 6 months
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Time frame: 6 months
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 6 months
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
Time frame: 12 months
Drug Use Disorders Identification Test (DUDIT)
Time frame: 12 months
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Time frame: 12 months
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 12 months

Results and safety

Results posted to the registry on 29 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
eScreen	101	33
Control Group	101	33

Primary outcome: Drug Use Disorders Identification Test-Consumption (DUDIT-C)

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	eScreen n = 101	Control Group n = 101
Value	4.8 (3.9)	4.5 (4.1)

Population analysed: The analyses have been carried out according to both the Intention To Treat method (ITT) and according to Per protocols method (PP). Where possible, missing values were imputed with last observation carried backwards. In cases where no follow-up data were available, the last observation was carried forward.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 months from baseline recruitment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eScreen	0 of 101 (0%)	0 of 101 (0%)	Not reported
Control Group	0 of 101 (0%)	0 of 101 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Results publication: PubMed 22613182Sinadinovic K, Wennberg P, Berman AH. Targeting problematic users of illicit drugs with Internet-based screening and brief intervention: a randomized controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):42-50. doi: 10.1016/j.drugalcdep.2012.04.016. Epub 2012 May 20.
Results publication: PubMed 24650825Sinadinovic K, Wennberg P, Berman AH. Internet-based screening and brief intervention for illicit drug users: a randomized controlled trial with 12-month follow-up. J Stud Alcohol Drugs. 2014 Mar;75(2):313-8. doi: 10.15288/jsad.2014.75.313.
Anne H Berman's profile at Uppsala UniversityLink provided by the sponsor.
Web based self-monitoring 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 study testing eScreen 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 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 13 Nov 2023. 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?

Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Drug Use Disorders Identification Test-Consumption (DUDIT-C) (time frame: 3 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 NCT01532388, which also lists 4 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 13 Nov 2023.