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Randomized Controlled Trial of eScreen for Problematic Drug Use

Randomized Controlled Trial of eScreen for Problematic Drug Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01532388
Enrollment
202
Registered
2012-02-14
Start date
2009-09-30
Completion date
2012-05-31
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problematic AOD Use

Keywords

Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention

Brief 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.

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.

Interventions

BEHAVIORALeScreen

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* DUDIT \>0

Exclusion criteria

* DUDIT = 0

Design outcomes

Primary

MeasureTime frameDescription
Drug Use Disorders Identification Test-Consumption (DUDIT-C)3 monthsThe 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.

Secondary

MeasureTime frameDescription
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)3 monthsThe 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.
Alcohol Use Disorders Identification Test - AUDIT3 monthsThe 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.
Drug Use Disorders Identification Test (DUDIT)3 monthsThe 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.
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)6 monthsThe 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.
Alcohol Use Disorders Identification Test (AUDIT)6 monthsThe 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.
Drug Use Disorders Identification Test-Consumption (DUDIT-C)6 monthsThe 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.

Countries

Sweden

Participant flow

Participants by arm

ArmCount
eScreen
Web based self-monitoring of problematic alcohol and drug use. eScreen: Web based self-monitoring of problematic alcohol and drug use.
101
Control Group
Untreated control group
101
Total202

Withdrawals & dropouts

PeriodReasonFG000FG001
12-month Follow-upLost to Follow-up6967
3-month Follow-upLost to Follow-up6868
6-month Follow-upLost to Follow-up7466

Baseline characteristics

CharacteristicControl GroupeScreenTotal
Age, Categorical
<=18 years
4 Participants5 Participants9 Participants
Age, Categorical
>=65 years
2 Participants1 Participants3 Participants
Age, Categorical
Between 18 and 65 years
95 Participants95 Participants190 Participants
Age, Continuous31.93 years
STANDARD_DEVIATION 12.37
33.16 years
STANDARD_DEVIATION 13.34
32.54 years
STANDARD_DEVIATION 12.84
Region of Enrollment
Sweden
101 participants101 participants202 participants
Sex: Female, Male
Female
42 Participants48 Participants90 Participants
Sex: Female, Male
Male
59 Participants53 Participants112 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1010 / 101
serious
Total, serious adverse events
0 / 1010 / 101

Outcome results

Primary

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.8 units on a scaleStandard Deviation 3.9
Control GroupDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.5 units on a scaleStandard Deviation 4.1
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test - AUDIT18.5 units on a scaleStandard Deviation 10.1
Control GroupAlcohol Use Disorders Identification Test - AUDIT17.7 units on a scaleStandard Deviation 10.9
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test (AUDIT)16.9 units on a scaleStandard Deviation 10.8
Control GroupAlcohol Use Disorders Identification Test (AUDIT)17.1 units on a scaleStandard Deviation 10.5
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test (AUDIT)17.4 units on a scaleStandard Deviation 10.7
Control GroupAlcohol Use Disorders Identification Test (AUDIT)17.3 units on a scaleStandard Deviation 10.7
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test - Consumption (AUDIT-C)6.9 units on a scaleStandard Deviation 3.1
Control GroupAlcohol Use Disorders Identification Test - Consumption (AUDIT-C)6.7 units on a scaleStandard Deviation 3.4
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.3 units on a scaleStandard Deviation 3.3
Control GroupAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.5 units on a scaleStandard Deviation 3.4
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.5 units on a scaleStandard Deviation 3.3
Control GroupAlcohol Use Disorders Identification Test-Consumption (AUDIT-C)6.5 units on a scaleStandard Deviation 3.4
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.4 units on a scaleStandard Deviation 4.2
Control GroupDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.0 units on a scaleStandard Deviation 4.1
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.7 units on a scaleStandard Deviation 4.2
Control GroupDrug Use Disorders Identification Test-Consumption (DUDIT-C)4.2 units on a scaleStandard Deviation 4.1
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test (DUDIT)11.0 units on a scaleStandard Deviation 12.8
Control GroupDrug Use Disorders Identification Test (DUDIT)9.9 units on a scaleStandard Deviation 12.2
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test (DUDIT)12.0 units on a scaleStandard Deviation 12.6
Control GroupDrug Use Disorders Identification Test (DUDIT)10.6 units on a scaleStandard Deviation 12.1
Secondary

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

Population: The analyzes 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.

ArmMeasureValue (MEAN)Dispersion
eScreenDrug Use Disorders Identification Test (DUDIT)11.6 units on a scaleStandard Deviation 12.8
Control GroupDrug Use Disorders Identification Test (DUDIT)10.4 units on a scaleStandard Deviation 12.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026