Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD) (SOFIE-5YFU)

This study has been completed.

Sponsor:

Information provided by:

Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01145690

First received: June 15, 2010

Last updated: October 25, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 15, 2010
Last Updated Date	October 25, 2010
Start Date ^ICMJE	June 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01145690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Measures of social anxiety in interaction and performance situations - SIAS & SPS [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ] Measure of depressive symptoms - MADRS-S [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ] Measure of general anxiety - BAI [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ] Measure of quality of life - QOLI [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ] Measure of social anxiety disorder diagnosis - SPSQ [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)
Official Title ^ICMJE	Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Brief Summary	Social anxiety disorder (SAD) 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 anxiety disorder. In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The sample is constituted by all 80 participants who received Internet-based CBT in 2005 within the context of a RCT in Sweden.
Condition ^ICMJE	Social Anxiety Disorder
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Internet-based CBT All participants in this cohort received Internet-based CBT for social anxiety disorder in 2005. All participants were Swedish adults with a DSM-IV diagnosis of social anxiety disorder.
Publications *	Hedman E, Furmark T, Carlbring P, Ljótsson B, Rück C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	80
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01145690
Other Study ID Numbers ^ICMJE	SOFIE-5YFU
Has Data Monitoring Committee	No
Responsible Party	Nils Lindefors, MD, PHD, professor, Stockholm County Council and Karolinska Institute
Study Sponsor ^ICMJE	Karolinska Institutet
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Karolinska Institutet
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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