Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
Primary Purpose
Phobia, Social
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Task Concentration Training
Standard CBT
Sponsored by
About this trial
This is an interventional treatment trial for Phobia, Social focused on measuring Social Anxiety Disorder, Social Phobia, Fear of blushing, attention, attention training, cognitive behavior therapy
Eligibility Criteria
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
Sites / Locations
- TU Dresden
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Task Concentration Training
Standard CBT
Wait list control
Arm Description
Task Concentration Training TCT following Bögels et al. (1997)
standard Cognitive Behavior Therapy, standard CBT following the model of Clark and Wells (1995).
Wait list control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Changes in objective attention test data
Full Information
NCT ID
NCT00751465
First Posted
September 11, 2008
Last Updated
September 10, 2015
Sponsor
Technische Universität Dresden
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00751465
Brief Title
Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
Official Title
Clinical Specificity of Dysfunctional Habitual Attention Processes in Fear of Blushing and Their Changeability
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social
Keywords
Social Anxiety Disorder, Social Phobia, Fear of blushing, attention, attention training, cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Task Concentration Training
Arm Type
Active Comparator
Arm Description
Task Concentration Training TCT following Bögels et al. (1997)
Arm Title
Standard CBT
Arm Type
Active Comparator
Arm Description
standard Cognitive Behavior Therapy, standard CBT following the model of Clark and Wells (1995).
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Wait list control group
Intervention Type
Behavioral
Intervention Name(s)
Task Concentration Training
Intervention Description
Task Concentration Training TCT following Bögels et al. (1997).
Intervention Type
Behavioral
Intervention Name(s)
Standard CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Social Phobia Scale
Description
Brief Social Phobia Scale BSPS is an interview assessing fear and avoidance in seven social situations and severity of four bodily symptoms.
Time Frame
pre, within, post, 6-months, and 12-months follow-up
Secondary Outcome Measure Information:
Title
Social Phobia Composite
Description
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.
Time Frame
pre, within, post, 6-months, and 12-months follow-up
Title
Changes in objective attention test data
Time Frame
within, post, 6-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Hoyer, Prof. Dr.
Organizational Affiliation
University of Technology Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
TU Dresden
City
Dresden
ZIP/Postal Code
01187
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19557558
Citation
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.
Results Reference
background
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Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
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