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Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD) (SOFIE-5YFU)

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ClinicalTrials.gov Identifier: NCT01145690
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 26, 2010
Information provided by:

Study Description
Brief 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.

Condition or disease
Social Anxiety Disorder

Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Study Start Date : June 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Groups and Cohorts

Internet-based CBT
All participants in this cohort received Internet-based CBT for social anxiety disorder in 2005. All participants were Swedish adults with a DSM-IV diagnosis of social anxiety disorder.

Outcome Measures

Primary Outcome Measures :
  1. Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 5-year follow-up ]

Secondary Outcome Measures :
  1. Measures of social anxiety in interaction and performance situations - SIAS & SPS [ Time Frame: 5-year follow-up ]
  2. Measure of depressive symptoms - MADRS-S [ Time Frame: 5-year follow-up ]
  3. Measure of general anxiety - BAI [ Time Frame: 5-year follow-up ]
  4. Measure of quality of life - QOLI [ Time Frame: 5-year follow-up ]
  5. Measure of social anxiety disorder diagnosis - SPSQ [ Time Frame: 5-year follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The sample is constituted by all 80 participants who received Internet-based CBT in 2005 within the context of a RCT in Sweden.

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): NCT01145690

Psykiatri Sydväst, Stockholm County Council
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
More 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: NCT01145690     History of Changes
Other Study ID Numbers: SOFIE-5YFU
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: June 2010

Keywords provided by Karolinska Institutet:
cognitive behaviour therapy

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