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

Substance Use Disorders (SUD) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885026
• Other study ID #: 2012/1138-31/1
• Secondary ID: KI 4-2007/2013
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: January 31, 2016

Study information

• Verified date: October 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 31, 2016
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Substance Use Disorders (SUD)
• Substance-Related Disorders

Intervention

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.
• Assessment only of alcohol and drug use.
Assessment of alcohol and drug use at baseline and follow-up.
• Internet-based treatment for depression or anxiety
Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & 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. 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. — 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. Epub 2012 May 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in health parameters over time	Health-related questions on wellbeing, sleep, concentration, energy, social life, sadness and current life meaning, etc.	3, 6 and 12 months
Primary	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	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).	3, 6 and 12 months

External Links

•   Link to participant registration site.