Phobic DisordersNCT00000370
Treatment of Social Phobia
A study testing Cognitive behavior therapy, Performance-based exposure therapy and Psychosocial intervention in people with Phobic Disorders and Social Phobia, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phobic Disorders, Social Phobia, Public Speaking Anxiety
- What is being tested?
- Cognitive behavior therapy, Performance-based exposure therapy and Psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1998to Feb 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
- Patients must have:
- Social phobia with public speaking anxiety.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02215
About this study
Official title: Treatment of Social Phobia: Mediators And Moderators
Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in actual public speaking sessions), not only helps patients overcome this fear but also helps them overcome their more general social fears. However, little is known about how this change occurs during therapy. This study tries to identify the factors that contribute most to successful therapy.
Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not receive treatment. Study leaders will monitor patient response to treatment through behavioral tests and assessments.
Read more
An individual may be eligible for this study if he/she:
Has social phobia with public speaking anxiety.
Read the detailed description
The primary goal of the present study is to identify the mediators and moderators of change in the treatment of social phobia and, in so doing suggest a common mechanism of action for all brief psychosocial interventions. Perceived self-efficacy of social behavior, negative cognitive appraisal (estimated social costs), and perceived emotional control will be considered as potential mediators; avoidant personality disorder and the generalized subtype of social phobia will be considered as potential predictors for poor treatment outcome.
Social phobia is a very prevalent and debilitating disorder, with public speaking anxiety being the most common fear among socially phobic individuals. Although there are a number of effective psychosocial treatments for social phobia (e.g., cognitive-behavioral treatments and exposure therapy) very little is known about the underlying mechanism of therapeutic change (i.e., the mediators of change), and the variables that are predictive of treatment outcome (i.e., the moderators of change). Furthermore, it is unclear why treating individuals for their public speaking anxiety can generalize to other untreated social fears.
Patients are randomly assigned to either a comprehensive cognitive-behavioral treatment for social phobia (n=43), a performance-based exposure treatment for public speaking anxiety without cognitive intervention (n=43), or a waitlist control group (n=43). Clinician ratings, behavioral tests, cognitive assessments, subjective ratings, and physiological measures are employed to determine the degree of therapeutic gains in various social phobia domains. The main hypothesis is that perceived emotional control will mediate treatment outcome and generality of effectiveness independent of the specific treatment condition.
- Conditions
- Phobic Disorders, Social Phobia, Public Speaking Anxiety
- Being tested
- Cognitive behavior therapy, Performance-based exposure therapy, Psychosocial intervention
- Keywords
- Cognitive Therapy, Cost of Illness, Female, Human, Male, Phobic Disorders, Phobic Disorders -- *therapy, Phobic Disorders -- pathology
- Medical subject headings
- Phobic Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Performance-based exposure therapyBehavioural
Psychosocial interventionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startMay 1998
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stefan G. Hofmann, Boston University Charles River Campus
- Investigators
- Stefan Hofmann, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000370
- Sponsor's protocol ID
- R29MH057326
- Other IDs
- R29MH057326, DSIR AT-AS
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 1999
- Last updated
- 18 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Social Phobia: Mediators And Moderators
- ClinicalTrials.gov ID
- NCT00000370
- Acronym / sponsor ID
- R29MH057326
- Conditions
- Phobic Disorders, Social Phobia, Public Speaking Anxiety
- Keywords
- Cognitive Therapy, Cost of Illness, Female, Human, Male, Phobic Disorders, Phobic Disorders -- *therapy, Phobic Disorders -- pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 1998
- Study completion
- Feb 2003
- First posted
- 3 Nov 1999 (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.
Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in actual public speaking sessions), not only helps patients overcome this fear but also helps them overcome their more general social fears. However, little is known about how this change occurs during therapy. This study tries to identify the factors that contribute most to successful therapy.
Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not receive treatment. Study leaders will monitor patient response to treatment through behavioral tests and assessments.
An individual may be eligible for this study if he/she:
Has social phobia with public speaking anxiety.
Detailed description
The primary goal of the present study is to identify the mediators and moderators of change in the treatment of social phobia and, in so doing suggest a common mechanism of action for all brief psychosocial interventions. Perceived self-efficacy of social behavior, negative cognitive appraisal (estimated social costs), and perceived emotional control will be considered as potential mediators; avoidant personality disorder and the generalized subtype of social phobia will be considered as potential predictors for poor treatment outcome.
Social phobia is a very prevalent and debilitating disorder, with public speaking anxiety being the most common fear among socially phobic individuals. Although there are a number of effective psychosocial treatments for social phobia (e.g., cognitive-behavioral treatments and exposure therapy) very little is known about the underlying mechanism of therapeutic change (i.e., the mediators of change), and the variables that are predictive of treatment outcome (i.e., the moderators of change). Furthermore, it is unclear why treating individuals for their public speaking anxiety can generalize to other untreated social fears.
Patients are randomly assigned to either a comprehensive cognitive-behavioral treatment for social phobia (n=43), a performance-based exposure treatment for public speaking anxiety without cognitive intervention (n=43), or a waitlist control group (n=43). Clinician ratings, behavioral tests, cognitive assessments, subjective ratings, and physiological measures are employed to determine the degree of therapeutic gains in various social phobia domains. The main hypothesis is that perceived emotional control will mediate treatment outcome and generality of effectiveness independent of the specific treatment condition.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- -
- Social phobia with public speaking anxiety.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive behavior therapy | Behavioural | – |
| Performance-based exposure therapy | Behavioural | – |
| Psychosocial intervention | Behavioural | – |
Primary outcome
Not reported in the source record.
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 18 Jan 2018.
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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.
Stefan Hofmann, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy, Performance-based exposure therapy and Psychosocial intervention in people with Phobic Disorders and Social Phobia, run by Boston University Charles River Campus at 1 site in United States.
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 3 inclusion and 0 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 18 Jan 2018. 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 United States. 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.
Where can I read the original study information?
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 18 Jan 2018.