Phobia, SocialNCT00751465
Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
A study testing Task Concentration Training and Standard CBT in people with Phobia, Social, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobia, Social
- What is being tested?
- Task Concentration Training and Standard CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Social anxiety disorder (DSM-IV criteria) and fear of blushing as main complaint
- age: 18-70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Phobia, Social
- Being tested
- Task Concentration Training, Standard CBT
- Keywords
- Social Anxiety Disorder, Social Phobia, Fear of blushing, attention, attention training, cognitive behavior therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Concentration TrainingBehavioural
Task Concentration Training TCT following Bögels et al. (1997).
Standard CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Task Concentration Training | Active comparator | Task Concentration Training TCT following Bögels et al. (1997) Receives: Behavioral: Task Concentration Training |
| Standard CBT | Active comparator | standard Cognitive Behavior Therapy, standard CBT following the model of Clark and Wells (1995). Receives: Behavioral: Standard CBT |
| Wait list control | No intervention | Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre, within, post, 6-months, and 12-months follow-up
Secondary outcomes (2)
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.
Measured: pre, within, post, 6-months, and 12-months follow-up
Changes in objective attention test data
Measured: within, post, 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phobia, SocialStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Samia Chaker, Technische Universität Dresden
- Investigators
- Jürgen Hoyer, Prof. Dr., Principal investigator, University of Technology Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751465
- Sponsor's protocol ID
- EK198082007
- Other IDs
- DFG HO1900/5-1
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2008
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19557558
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Specificity of Dysfunctional Habitual Attention Processes in Fear of Blushing and Their Changeability
- ClinicalTrials.gov ID
- NCT00751465
- Acronym / sponsor ID
- EK198082007
- Conditions
- Phobia, Social
- Keywords
- Social Anxiety Disorder, Social Phobia, Fear of blushing, attention, attention training, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Task Concentration Training | Active comparator | Behavioral: Task Concentration TrainingTask Concentration Training TCT following Bögels et al. (1997) |
| Standard CBT | Active comparator | Behavioral: Standard CBTstandard Cognitive Behavior Therapy, standard CBT following the model of Clark and Wells (1995). |
| Wait list control | No intervention | –Wait list control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Social anxiety disorder (DSM-IV criteria) and fear of blushing as main complaint
- age: 18-70
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task Concentration TrainingTask Concentration Training TCT following Bögels et al. (1997). | Behavioural | Task Concentration Training |
| Standard CBTStandard 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. | Behavioural | Standard CBT |
Primary outcome
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.
2 secondary outcomes
Social Phobia Composite
Time frame: pre, within, post, 6-months, and 12-months follow-up
Changes in objective attention test data
Time frame: within, post, 6-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Background: PubMed 19557558Chaker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Hoyer, Prof. Dr. principal investigator
University of Technology Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Concentration Training and Standard CBT in people with Phobia, Social, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Social Phobia Scale (time frame: pre, within, post, 6-months, and 12-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00751465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.