- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751465
Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
September 10, 2015 updated by: Samia Chaker, Technische Universität Dresden
Clinical Specificity of Dysfunctional Habitual Attention Processes in Fear of Blushing and Their Changeability
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dresden, Germany, 01187
- TU Dresden
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Task Concentration Training
Task Concentration Training TCT following Bögels et al. (1997)
|
Task Concentration Training TCT following Bögels et al. (1997).
|
ACTIVE_COMPARATOR: Standard CBT
standard Cognitive Behavior Therapy, standard CBT following the model of Clark and Wells (1995).
|
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.
|
NO_INTERVENTION: Wait list control
Wait list control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Social Phobia Scale
Time Frame: pre, within, post, 6-months, and 12-months follow-up
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Phobia Composite
Time Frame: pre, within, post, 6-months, and 12-months follow-up
|
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
|
Changes in objective attention test data
Time Frame: within, post, 6-months follow-up
|
within, post, 6-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jürgen Hoyer, Prof. Dr., University of Technology Dresden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
September 11, 2008
First Submitted That Met QC Criteria
September 11, 2008
First Posted (ESTIMATE)
September 12, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 11, 2015
Last Update Submitted That Met QC Criteria
September 10, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK198082007
- DFG HO1900/5-1 (OTHER_GRANT: Deutsche Forschungsgemeinschaft DFG HO1900/5-1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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