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

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ClinicalTrials.gov Identifier: NCT00564967
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:

Study Description
Brief 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).


Condition or disease Intervention/treatment Phase
Social Phobia Behavioral: CBT via the Internet Behavioral: CBT group therapy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : November 2007
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.)


Outcome Measures

Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures :
  1. SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders