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
• 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

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

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