Substance-focused SBI as a Complement to Internet-based Psychiatric Treatment: RCT (eScreeniPsy)

October 2, 2018 updated by: Anne H Berman, Karolinska Institutet

Substance-use Focused Screening and Brief Intervention as a Complement to Internet-based Psychiatric Treatment for Depression, Panic Disorder or Social Phobia: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluated 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. The design was 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) were 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 was that the group receiving the eScreen intervention would reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level. The results have not yet been analyzed due to technical issues. However, qualitative interviews have been conducted with participants and our intention is to publish the qualitative results in tandem with the quantitative results available.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11364
        • Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eScreen
Web based self-monitoring of problematic alcohol and drug use, and Internet-based treatment for depression or anxiety
Behavioral: eScreen
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.
Behavioral: Internet-based treatment for depression or anxiety
Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
Experimental: Control
Assessment only of alcohol and drug use and Internet-based treatment for depression or anxiety
Behavioral: Internet-based treatment for depression or anxiety
Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
Behavioral: Assessment only of alcohol and drug use.
Assessment of alcohol and drug use at baseline and follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the total AUDIT-C score
Time Frame: 3, 6 and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 3, 6 and 12 months
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
3, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in health parameters over time
Time Frame: 3, 6 and 12 months
Health-related questions on wellbeing, sleep, concentration, energy, social life, sadness and current life meaning, etc.
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 31, 2016

Study Completion (Actual)

January 31, 2016

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1138-31/1
  • KI 4-2007/2013 (Other Identifier: Karolinska Institutet, Legal Dept)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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