Trial Outcomes & Findings for Randomized Controlled Trial of eScreen for Problematic Drug Use (NCT NCT01532388)
NCT ID: NCT01532388
Last Updated: 2023-11-13
Results Overview
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.
COMPLETED
NA
202 participants
3 months
2023-11-13
Participant Flow
Participant milestones
| Measure |
eScreen
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
Untreated control group
|
|---|---|---|
|
3-month Follow-up
STARTED
|
101
|
101
|
|
3-month Follow-up
COMPLETED
|
33
|
33
|
|
3-month Follow-up
NOT COMPLETED
|
68
|
68
|
|
6-month Follow-up
STARTED
|
101
|
101
|
|
6-month Follow-up
COMPLETED
|
27
|
35
|
|
6-month Follow-up
NOT COMPLETED
|
74
|
66
|
|
12-month Follow-up
STARTED
|
101
|
101
|
|
12-month Follow-up
COMPLETED
|
32
|
34
|
|
12-month Follow-up
NOT COMPLETED
|
69
|
67
|
Reasons for withdrawal
| Measure |
eScreen
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
Untreated control group
|
|---|---|---|
|
3-month Follow-up
Lost to Follow-up
|
68
|
68
|
|
6-month Follow-up
Lost to Follow-up
|
74
|
66
|
|
12-month Follow-up
Lost to Follow-up
|
69
|
67
|
Baseline Characteristics
Randomized Controlled Trial of eScreen for Problematic Drug Use
Baseline characteristics by cohort
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
33.16 years
STANDARD_DEVIATION 13.34 • n=99 Participants
|
31.93 years
STANDARD_DEVIATION 12.37 • n=107 Participants
|
32.54 years
STANDARD_DEVIATION 12.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
101 participants
n=99 Participants
|
101 participants
n=107 Participants
|
202 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
|
4.8 units on a scale
Standard Deviation 3.9
|
4.5 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test (DUDIT)
|
12.0 units on a scale
Standard Deviation 12.6
|
10.6 units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
|
6.9 units on a scale
Standard Deviation 3.1
|
6.7 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test - AUDIT
|
18.5 units on a scale
Standard Deviation 10.1
|
17.7 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
|
4.7 units on a scale
Standard Deviation 4.2
|
4.2 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test (DUDIT)
|
11.6 units on a scale
Standard Deviation 12.8
|
10.4 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
|
6.5 units on a scale
Standard Deviation 3.3
|
6.5 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
17.4 units on a scale
Standard Deviation 10.7
|
17.3 units on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test-Consumption (DUDIT-C)
|
4.4 units on a scale
Standard Deviation 4.2
|
4.0 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Drug Use Disorders Identification Test (DUDIT)
|
11.0 units on a scale
Standard Deviation 12.8
|
9.9 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
|
6.3 units on a scale
Standard Deviation 3.3
|
6.5 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
eScreen
n=101 Participants
Web based self-monitoring of problematic alcohol and drug use.
eScreen: Web based self-monitoring of problematic alcohol and drug use.
|
Control Group
n=101 Participants
Untreated control group
|
|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
16.9 units on a scale
Standard Deviation 10.8
|
17.1 units on a scale
Standard Deviation 10.5
|
Adverse Events
eScreen
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place