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Randomized Controlled Trial of eScreen for Problematic Drug Use

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01532388
First received: October 27, 2011
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

Objectives: This study compares 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 are assessed after 3, 6 and 12 months.

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


Condition Intervention Phase
Problematic Drug Use
 Behavioral: eScreen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of eScreen for Problematic Drug Use

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Drug Use Disorders Identification Test-Consumption (DUDIT-C) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The primary outcome measure for this trial was the change in total DUDIT score for the first four DUDIT questions, as a measure of drug consumption only, referred to as the DUDIT-C.


Secondary Outcome Measures:
  • Drug Use Disorders Identification Test (DUDIT) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems).


Estimated Enrollment: 202
Study Start Date: September 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eScreen
Web based self-monitoring of problematic alcohol and drug use.
 Behavioral: eScreen
Web based self-monitoring of problematic alcohol and drug use.
No Intervention: Control group
Untreated control group

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DUDIT >0

Exclusion Criteria:

  • DUDIT = 0
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532388

Locations
Sweden
Karolinska institutet, Department of Clinical Neurosciene
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anne H Berman, PhD Karolinska Institutet
  More Information

Additional Information:
For research group profile search Berman  This link exits the ClinicalTrials.gov site
Web based self-monitoring site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01532388     History of Changes
Other Study ID Numbers: 2008/308-31/5D
Study First Received: October 27, 2011
Last Updated: February 9, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Karolinska Institutet:
Randomized Controlled Trial
Alcohol
Drugs
 Internet
Screening
Brief intervention

ClinicalTrials.gov processed this record on May 22, 2013