A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy (IS1)
Primary Purpose
Social Phobia
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
CBT via the Internet
CBT group therapy
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia
Eligibility Criteria
Inclusion Criteria:
- Must have a primary diagnosis of social phobia
Exclusion Criteria:
- Substance abuse during the last 6 months
- Other dominating diagnosis (not phobic personality disorder)
- A history of bipolar disorder or psychosis
- Major depression according to DSM-IV and >20 on madrs-s
- Risk of suicide
- Start of medication or change of dosis during the last 2 months
- Other parallel psychological treatment
- Previous CBT (last 3 years) for social phobia
Sites / Locations
- Psykiatri Sydväst, Stockholm County Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
CBT via the Internet
15 weeks, CBT group therapy, 1 session/week (2.5 hours).
Outcomes
Primary Outcome Measures
Liebowitz Social Anxiety Scale (LSAS)
Secondary Outcome Measures
SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP
Full Information
NCT ID
NCT00564967
First Posted
November 28, 2007
Last Updated
October 25, 2010
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT00564967
Brief Title
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
Acronym
IS1
Official Title
A Comparison Between Internet-based Self-help Therapy and Group Therapy for Social Phobia - A Clinical Equivalence Trial Using Cognitive Behavioural Therapy (CBT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social phobia.
To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered via the Internet. The study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. The primary outcome measure is Liebowitz Social Anxiety Scale (LSAS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CBT via the Internet
Arm Title
2
Arm Type
Experimental
Arm Description
15 weeks, CBT group therapy, 1 session/week (2.5 hours).
Intervention Type
Behavioral
Intervention Name(s)
CBT via the Internet
Intervention Description
15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week),
Intervention Type
Behavioral
Intervention Name(s)
CBT group therapy
Intervention Description
15 weeks, 1 session/week, (2,5 hours.)
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale (LSAS)
Secondary Outcome Measure Information:
Title
SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have a primary diagnosis of social phobia
Exclusion Criteria:
Substance abuse during the last 6 months
Other dominating diagnosis (not phobic personality disorder)
A history of bipolar disorder or psychosis
Major depression according to DSM-IV and >20 on madrs-s
Risk of suicide
Start of medication or change of dosis during the last 2 months
Other parallel psychological treatment
Previous CBT (last 3 years) for social phobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nils lindefors
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psykiatri Sydväst, Stockholm County Council
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24260145
Citation
Andersson E, Ruck C, Lavebratt C, Hedman E, Schalling M, Lindefors N, Eriksson E, Carlbring P, Andersson G, Furmark T. Genetic polymorphisms in monoamine systems and outcome of cognitive behavior therapy for social anxiety disorder. PLoS One. 2013 Nov 15;8(11):e79015. doi: 10.1371/journal.pone.0079015. eCollection 2013. Erratum In: PLoS One. 2016 Oct 18;11(10 ):e0165249.
Results Reference
derived
PubMed Identifier
22320999
Citation
Hedman E, Andersson E, Ljotsson B, Andersson G, Andersson E, Schalling M, Lindefors N, Ruck C. Clinical and genetic outcome determinants of Internet- and group-based cognitive behavior therapy for social anxiety disorder. Acta Psychiatr Scand. 2012 Aug;126(2):126-36. doi: 10.1111/j.1600-0447.2012.01834.x. Epub 2012 Feb 9.
Results Reference
derived
PubMed Identifier
21483704
Citation
Hedman E, Andersson G, Ljotsson B, Andersson E, Ruck C, Mortberg E, Lindefors N. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial. PLoS One. 2011 Mar 25;6(3):e18001. doi: 10.1371/journal.pone.0018001.
Results Reference
derived
Links:
URL
http://www.internetpsykiatri.se
Description
Information about the study and how to enroll is provided
Learn more about this trial
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
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