NCT01885026

Brief Summary

Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. 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: This is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) and/or problematic drug use (DUDIT \> 1 for both men and women) are randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months. The hypothesis is that the group receiving the eScreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

2.6 years

First QC Date

June 20, 2013

Last Update Submit

October 2, 2018

Conditions

Keywords

Randomized Controlled TrialAlcoholDrugsInternetScreeningBrief intervention

Outcome Measures

Primary Outcomes (1)

  • Change in the total AUDIT-C score

    The primary outcome measure for this trial is the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.

    3, 6 and 12 months

Secondary Outcomes (1)

  • Alcohol Use Disorders Identification Test (AUDIT)

    3, 6 and 12 months

Other Outcomes (1)

  • Changes in health parameters over time

    3, 6 and 12 months

Study Arms (2)

eScreen

EXPERIMENTAL

Web based self-monitoring of problematic alcohol and drug use, and Internet-based treatment for depression or anxiety

Behavioral: eScreenBehavioral: Internet-based treatment for depression or anxiety

Control

EXPERIMENTAL

Assessment only of alcohol and drug use and Internet-based treatment for depression or anxiety

Behavioral: Assessment only of alcohol and drug use.Behavioral: Internet-based treatment for depression or anxiety

Interventions

eScreenBEHAVIORAL

Access to the eScreen platform offering assessment of alcohol and drug use, with automated feedback on problematic or non-problematic use. Follow-up over time based on user needs.

eScreen

Assessment of alcohol and drug use at baseline and follow-up.

Control

Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.

ControleScreen

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AUDIT \>7 for men and AUDIT \>5 for women, and/or DUDIT \>0

You may not qualify if:

  • DUDIT = 0 and AUDIT \<8 (men) or \<6 (women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Stockholm, 11364, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 20092953BACKGROUND
  • 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.

    PMID: 22613182BACKGROUND
  • 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.

    PMID: 24650825BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 24, 2013

Study Start

July 1, 2013

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations