A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy

Social Phobia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564967
• Other study ID #: IS1
• Secondary ID: Dnr 2005/178-31
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2007
• Last updated: October 25, 2010
• Start date: November 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2009
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• CBT via the Internet
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),
• CBT group therapy
15 weeks, 1 session/week, (2,5 hours.)

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	Liebowitz Social Anxiety Scale (LSAS)			No
Secondary	SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP			No

External Links

•   Information about the study and how to enroll is provided