Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00751465
Other study ID # EK198082007
Secondary ID DFG HO1900/5-1
Status Completed
Phase N/A
First received September 11, 2008
Last updated September 10, 2015
Start date November 2008
Est. completion date December 2010

Study information

Verified date September 2015
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Blushing is associated with a heightened self-focused attention. In our study we are interested if this self-focused attention can be shown experimentally and if it can be changed by therapy and training. For the experimental part of the study, we want to compare blushing fearful individuals to social anxious participants who are not fearful of blushing and to healthy controls who report to blush either seldom or quite often. In the therapeutical part of our study, we compare an attention training to the standard cognitive behavioral therapy for social anxiety disorder in an intensive group therapy approach.


Description:

Fear of blushing is a specific syndrome in social anxiety disorder. Although attentional biases for social anxiety disorders have often been reported, specific data for fear of blushing are still missing. In this study, dysfunctional attention processes are examined by the use of various questionnaire measures and attention tests (e.g. Stroop test, task switching paradigm) comparing fear of blushers, other social phobia patients, healthy volunteers who report to blush seldomly respectively often. The second goal of the study is to examine if these attention processes can be changed by training and therapy. Therefore, individuals who fulfill DSM-IV criteria for social anxiety disorder and report fear of blushing as main problem, are treated with attention training and with CBT for social anxiety disorder. Therapy will be held in the form of intensive weekend group therapy. Differences in outcomes for both therapy types and in changeability of attention processes on objective test data are examined. Stability of results are tested up to 6-month and 12-month after post-assessment.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Social anxiety disorder (DSM-IV criteria) and fear of blushing as main complaint

- age: 18-70

Exclusion Criteria:

- acute severe depression or bipolar disorder

- any disorder of ICD group F2

- acute and severe substance misuse

- any bodily illness which hinders from study participation

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Task Concentration Training
Task Concentration Training TCT following Bögels et al. (1997).
Standard CBT
Standard CBT following the Clark-and-Wells (1995) model of social anxiety disorder, relying on the German manual for SAD (stangier et al., 2006). Includes the model, role-plays with and without safetey behavior, video-feedback.

Locations

Country Name City State
Germany TU Dresden Dresden

Sponsors (2)

Lead Sponsor Collaborator
Technische Universität Dresden German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Chaker S, Hofmann SG, Hoyer J. Can a one-weekend group therapy reduce fear of blushing? Results of an open trial. Anxiety Stress Coping. 2010 May;23(3):303-18. doi: 10.1080/10615800903075132. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Social Phobia Scale Brief Social Phobia Scale BSPS is an interview assessing fear and avoidance in seven social situations and severity of four bodily symptoms. pre, within, post, 6-months, and 12-months follow-up No
Secondary Social Phobia Composite The social phobia composite includes several self-report measures like the Liebowitz Social Anxiety Scale, Social Phobia Scale, Social Interaction Anxiety Scale, and Social Phobia Inventory. pre, within, post, 6-months, and 12-months follow-up No
Secondary Changes in objective attention test data within, post, 6-months follow-up No
See also
  Status Clinical Trial Phase
Completed NCT02590770 - Gaze Contingent Feedback in Social Anxiety Disorder N/A
Completed NCT03630783 - Combined CBM For Social Anxiety in Turkey N/A
Terminated NCT00182533 - Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders Phase 4
Completed NCT01470469 - SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP) Phase 2
Not yet recruiting NCT05649059 - Investigating the Effects of Cannabidiol on Social Anxiety Disorder Phase 4
Completed NCT01557894 - Internet Treatment for Social Phobia in Romania N/A