Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145690
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:
Karolinska Institutet

Tracking Information
First Submitted Date June 15, 2010
First Posted Date June 17, 2010
Last Update Posted Date October 26, 2010
Study Start Date June 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2010)
Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 5-year follow-up ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2010)
  • Measures of social anxiety in interaction and performance situations - SIAS & SPS [ Time Frame: 5-year follow-up ]
  • Measure of depressive symptoms - MADRS-S [ Time Frame: 5-year follow-up ]
  • Measure of general anxiety - BAI [ Time Frame: 5-year follow-up ]
  • Measure of quality of life - QOLI [ Time Frame: 5-year follow-up ]
  • Measure of social anxiety disorder diagnosis - SPSQ [ Time Frame: 5-year follow-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)
Official Title Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Social Anxiety Disorder
Intervention Not Provided
Study 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.
Publications * Hedman E, Furmark T, Carlbring P, Ljótsson B, Rück C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39. doi: 10.2196/jmir.1776.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June 16, 2010)
80
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01145690
Other Study ID Numbers SOFIE-5YFU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nils Lindefors, MD, PHD, professor, Stockholm County Council and Karolinska Institute
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators Not Provided
PRS Account Karolinska Institutet
Verification Date June 2010