ClinicalTrials.gg
CompletedNCT01532388Updated Nov 13, 2023Results posted

Randomized Controlled Trial of eScreen for Problematic Drug Use

An interventional study of eScreen in Problematic AOD Use, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 15 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
15 Years to 99 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Problematic AOD Use

Keywords

  • Randomized Controlled Trial
  • Alcohol
  • Drugs
  • Internet
  • Screening
  • Brief intervention
03

In context

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • DUDIT >0

Exclusion criteria

Exclusion Criteria:

  • DUDIT = 0
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    eScreen

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

    Behavioral: eScreen

  • No intervention
    Control group

    Untreated control group

Interventions

  • BehavioraleScreen

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

  6. 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.

    Time frame: 6 months

  7. 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.

    Time frame: 6 months

  8. 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.

    Time frame: 12 months

  9. 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.

    Time frame: 12 months

  10. 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.

    Time frame: 12 months

  11. 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.

    Time frame: 12 months

07

Results

Posted Sep 29, 2020

Participant flow

3-month Follow-up
Participant flow — 3-month Follow-up
MilestoneeScreenControl Group
Started101101
Completed3333
Not completed6868
Withdrew: Lost to follow-up6868
6-month Follow-up
Participant flow — 6-month Follow-up
MilestoneeScreenControl Group
Started101101
Completed2735
Not completed7466
Withdrew: Lost to follow-up7466
12-month Follow-up
Participant flow — 12-month Follow-up
MilestoneeScreenControl Group
Started101101
Completed3234
Not completed6967
Withdrew: Lost to follow-up6967

Outcome measures

PrimaryDrug 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.

Time frame:
3 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test-Consumption (DUDIT-C)4.8 ± 3.94.5 ± 4.1
SecondaryDrug 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.

Time frame:
3 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test (DUDIT)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test (DUDIT)12.0 ± 12.610.6 ± 12.1
SecondaryAlcohol 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.

Time frame:
3 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)6.9 ± 3.16.7 ± 3.4
SecondaryAlcohol 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.

Time frame:
3 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test - AUDIT
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test - AUDIT18.5 ± 10.117.7 ± 10.9
SecondaryDrug 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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test-Consumption (DUDIT-C)4.7 ± 4.24.2 ± 4.1
SecondaryDrug 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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test (DUDIT)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test (DUDIT)11.6 ± 12.810.4 ± 12.2
SecondaryAlcohol 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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.5 ± 3.36.5 ± 3.4
SecondaryAlcohol 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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test (AUDIT)
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test (AUDIT)17.4 ± 10.717.3 ± 10.7
SecondaryDrug 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.

Time frame:
12 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test-Consumption (DUDIT-C)4.4 ± 4.24.0 ± 4.1
SecondaryDrug 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.

Time frame:
12 months
Reported as:
Mean · units on a scale
Drug Use Disorders Identification Test (DUDIT)
units on a scaleeScreenControl Group
Drug Use Disorders Identification Test (DUDIT)11.0 ± 12.89.9 ± 12.2
SecondaryAlcohol 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.

Time frame:
12 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.3 ± 3.36.5 ± 3.4
SecondaryAlcohol 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.

Time frame:
12 months
Reported as:
Mean · units on a scale
Alcohol Use Disorders Identification Test (AUDIT)
units on a scaleeScreenControl Group
Alcohol Use Disorders Identification Test (AUDIT)16.9 ± 10.817.1 ± 10.5

Adverse events

Collected over 13 months from baseline recruitment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
eScreen—0/101 (0%)0/101 (0%)
Control Group—0/101 (0%)0/101 (0%)

Baseline characteristics

All individuals who have registered for the study and registered mandatory baseline data have been included in the baseline analyses.

Age, Categorical
Age, Categorical(Participants)eScreenControl GroupTotal
<=18 years549
Between 18 and 65 years9595190
>=65 years123
Age, Continuous
Age, Continuous(years)eScreenControl GroupTotal
Mean33.16 ± 13.3431.93 ± 12.3732.54 ± 12.84
Sex: Female, Male
Sex: Female, Male(Participants)eScreenControl GroupTotal
Female484290
Male5359112
Region of Enrollment
Region of Enrollment(participants)eScreenControl GroupTotal
Sweden101101202
08

Study locations

1 site
  • Karolinska institutet, Department of Clinical Neurosciene
    Stockholm, 17176, Sweden
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Apr 2011 and a completion of May 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2020, 9 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2011
First posted
Feb 14, 2012
Start
Sep 2009
Primary completionActual
Apr 2011
CompletionActual
May 2012
Results first posted
Sep 29, 2020
Last update
Nov 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01532388
Responsible party
Anne H Berman (Affiliated Researcher, Karolinska Institutet) — Principal investigator
First posted
Feb 14, 2012
Start date
Sep 2009
Primary completion
Apr 2011
Completion
May 2012
Results posted
Sep 29, 2020
Last update
Nov 13, 2023

Study contacts

Anne H Berman, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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