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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01145690
First received: June 15, 2010
Last updated: October 25, 2010
Last verified: June 2010
  Purpose

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
Social Anxiety Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of social anxiety in interaction and performance situations - SIAS & SPS [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
  • Measure of depressive symptoms - MADRS-S [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
  • Measure of general anxiety - BAI [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
  • Measure of quality of life - QOLI [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]
  • Measure of social anxiety disorder diagnosis - SPSQ [ Time Frame: 5-year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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: NCT01145690

Locations
Sweden
Psykiatri Sydväst, Stockholm County Council
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
  More 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: NCT01145690     History of Changes
Other Study ID Numbers: SOFIE-5YFU
Study First Received: June 15, 2010
Last Updated: October 25, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
cognitive behaviour therapy

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014