A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy (IS1)

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00564967
First received: November 28, 2007
Last updated: October 25, 2010
Last verified: August 2009
  Purpose

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).


Condition Intervention Phase
Social Phobia
Behavioral: CBT via the Internet
Behavioral: CBT group therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale (LSAS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CBT via the Internet
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),
Experimental: 2
15 weeks, CBT group therapy, 1 session/week (2.5 hours).
Behavioral: CBT group therapy
15 weeks, 1 session/week, (2,5 hours.)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564967

Locations
Sweden
Psykiatri Sydväst, Stockholm County Council
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: nils lindefors Karolinska Institutet
  More Information

Additional Information:
No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nils Lindefors, MD, PHD, professor, Stockholm County Council and Karolinska Institute
ClinicalTrials.gov Identifier: NCT00564967     History of Changes
Other Study ID Numbers: IS1, Dnr 2005/178-31
Study First Received: November 28, 2007
Last Updated: October 25, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014