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NCT01145690 Clinical Trial

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

Social Anxiety Disorder Clinical Trial

— SOFIE-5YFU  

Official title:
Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01145690
Other study ID # SOFIE-5YFU
Secondary ID
Status Completed
Phase N/A
First received June 15, 2010
Last updated October 25, 2010
Start date June 2010
Est. completion date September 2010

Study information
Verified date June 2010
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Psykiatri Sydväst, Stockholm County Council Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) 5-year follow-up No
Secondary Measures of social anxiety in interaction and performance situations - SIAS & SPS 5-year follow-up No
Secondary Measure of depressive symptoms - MADRS-S 5-year follow-up No
Secondary Measure of general anxiety - BAI 5-year follow-up No
Secondary Measure of quality of life - QOLI 5-year follow-up No
Secondary Measure of social anxiety disorder diagnosis - SPSQ 5-year follow-up No
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