Randomized Controlled Trial of eScreen for Problematic Drug Use

Problematic AOD Use Clinical Trial

Official title:

Randomized Controlled Trial of eScreen for Problematic Drug Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532388
• Other study ID #: 2008/308-31/5D
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

Inclusion Criteria:

• DUDIT >0

Exclusion Criteria:

• DUDIT = 0

Related Conditions & MeSH terms

• Problematic AOD Use

Intervention

Behavioral:
• eScreen
Web based self-monitoring of problematic alcohol and drug use.

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neurosciene	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. Erratum In: Addict Behav. 2010 Sep;35(9):853. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months
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.	3 months
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.	3 months
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.	3 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	12 months
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.	12 months
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.	12 months
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.	12 months

External Links

•   Anne H Berman's profile at Uppsala University
•   Web based self-monitoring site