search
Back to results

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

Primary Purpose

Substance Use Disorders (SUD)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
eScreen
Assessment only of alcohol and drug use.
Internet-based treatment for depression or anxiety
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders (SUD) focused on measuring Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

eScreen

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

Full Information

First Posted
June 20, 2013
Last Updated
October 2, 2018
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT01885026
Brief Title
Substance-focused SBI as a Complement to Internet-based Psychiatric Treatment: RCT
Acronym
eScreeniPsy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 31, 2016 (Actual)
Study Completion Date
January 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders (SUD)
Keywords
Randomized Controlled Trial, Alcohol, Drugs, Internet, Screening, Brief intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eScreen
Arm Type
Experimental
Arm Description
Web based self-monitoring of problematic alcohol and drug use, and Internet-based treatment for depression or anxiety
Arm Title
Control
Arm Type
Experimental
Arm Description
Assessment only of alcohol and drug use and Internet-based treatment for depression or anxiety
Intervention Type
Behavioral
Intervention Name(s)
eScreen
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assessment only of alcohol and drug use.
Intervention Description
Assessment of alcohol and drug use at baseline and follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based treatment for depression or anxiety
Intervention Description
Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
Primary Outcome Measure Information:
Title
Change in the total AUDIT-C score
Description
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.
Time Frame
3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Time Frame
3, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Changes in health parameters over time
Description
Health-related questions on wellbeing, sleep, concentration, energy, social life, sadness and current life meaning, etc.
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
City
Stockholm
ZIP/Postal Code
11364
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20092953
Citation
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.
Results Reference
background
PubMed Identifier
22613182
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. Epub 2012 May 20.
Results Reference
background
PubMed Identifier
24650825
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.
Results Reference
background
Links:
URL
http://ipsy.epop.se
Description
Link to participant registration site.

Learn more about this trial

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

We'll reach out to this number within 24 hrs