Social PhobiaNCT00380731
Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
A study testing Individual Cognitive Behavioral Therapy in people with Social Phobia, run by Stanford University at 1 site in United States.
Trial summary
This study will evaluate the effect of cognitive behavioral therapy on the brain during emotional and behavioral responses to social stimuli in people with social phobia. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Individual Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2011
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV criteria for generalized social phobia
- English-speaking
- Eligible to participate in fMRI scanning
- Willing to use an effective form of contraception throughout the study
Who cannot join
- Currently undergoing any psychotherapy or pharmacotherapy (e.g, selective serotonin reuptake inhibitors, benzodiazepines, beta-blockers, anti-psychotics, blood thinners, thyroid hormone influencing agents, diabetic medications, or anticonvulsants)
- History of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, or head trauma with loss of consciousness for more than 5 minutes
- Smokes cigarettes daily
- History of or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, or schizoid personality disorders
- Suicidal thoughts
- Clinically significant and/or unstable medical disease
Show all 9Show fewer
- Pregnant or breastfeeding
- Alcohol or substance abuse or dependence within the 12 months prior to study entry
- History of or current seizure disorder (except febrile seizure disorder during childhood)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
This study will evaluate the effect of cognitive behavioral therapy on the brain during emotional and behavioral responses to social stimuli in people with social phobia.
Read the detailed description
Social phobia, also known as social anxiety disorder, is a common, often debilitating condition. People with social phobia experience high levels of anxiety when they participate in social situations or perform in front of others. Approximately 80% of social phobia cases occur before the age of 18, and often precede other anxiety, mood, and substance abuse or dependence disorders. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment method for most people with social phobia. Approximately 30% of people with the disorder, however, do not respond to CBT treatment. A better understanding of the neural mechanisms underlying social phobia and CBT's effect on these mechanisms will help physicians to better predict the best treatment for different patients. This study will evaluate the effect of CBT on how the brain processes emotional and behavioral responses to social stimuli in people with social phobia.
Participants in this open-label study will be randomly assigned to either immediate or delayed treatment with CBT. Participants who are assigned to immediate CBT will attend 16 sessions of individual CBT immediately following baseline assessments. Participants assigned to the delayed treatment condition will begin attending CBT sessions approximately 5 months following baseline assessments. Outcomes will be assessed for all participants at baseline, immediately post-treatment, and at Months 5 and 10 post-treatment. An fMRI scan will be used to measure neural responses to social stimuli, and various questionnaires and scales will be used to assess anxiety symptom severity. Participants in the delayed treatment group will be assessed on one additional occasion before they begin treatment after the 5-month waiting period.
- Conditions
- Social Phobia
- Being tested
- Individual Cognitive Behavioral Therapy
- Keywords
- Social Anxiety Disorder, Magnetic Resonance Imaging, 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.
Individual Cognitive Behavioral TherapyBehavioural
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive immediate cognitive behavioral therapy Receives: Behavioral: Individual Cognitive Behavioral Therapy |
| 2 | Experimental | Participants will receive cognitive behavioral therapy with a 16-week delayed start Receives: Behavioral: Individual Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale
Measured: Measured at Months 4, 7, 10, 13, and 16
fMRI BOLD response
Measured: Measured at Month 4
Behavioral assessment
Measured: Measured at Months 4 and 16
Secondary outcomes (4)
Clinical Global Impression Improvement Scale
Measured: Measured at Months 4 and 16
Social Interaction Anxiety Scale
Measured: Measured at Months 4, 10, and 16
Sheehan Disability Scale
Measured: Measured at Months 4, 10, and 16
Quality of Life Inventory
Measured: Measured at Months 4, 10, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James J. Gross, Stanford University
- Investigators
- James J. Gross, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380731
- Sponsor's protocol ID
- R01MH076074
- Other IDs
- R01MH076074, DATR A3-NSS
- Status last verified
- Nov 2011
- First submitted
- 22 Sep 2006
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morrison AS, Goldin PR, Gross JJ. Fear of negative and positive evaluation as mediators and moderators of treatment outcome in social anxiety disorder. J Anxiety Disord. 2024 Jun;104:102874. doi: 10.1016/j.janxdis.2024.102874. Epub 2024 May 1.
PubMed 38754336Butler RM, O'Day EB, Kaplan SC, Swee MB, Horenstein A, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Do sudden gains predict treatment outcome in social anxiety disorder? Findings from two randomized controlled trials. Behav Res Ther. 2019 Oct;121:103453. doi: 10.1016/j.brat.2019.103453. Epub 2019 Aug 9.
PubMed 31430688Goldin PR, Ziv M, Jazaieri H, Weeks J, Heimberg RG, Gross JJ. Impact of cognitive-behavioral therapy for social anxiety disorder on the neural bases of emotional reactivity to and regulation of social evaluation. Behav Res Ther. 2014 Nov;62:97-106. doi: 10.1016/j.brat.2014.08.005. Epub 2014 Aug 21.
PubMed 25193002Goldin PR, Lee I, Ziv M, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of change in emotion regulation and social anxiety during cognitive-behavioral therapy for social anxiety disorder. Behav Res Ther. 2014 May;56:7-15. doi: 10.1016/j.brat.2014.02.005. Epub 2014 Feb 28.
PubMed 24632110Ziv M, Goldin PR, Jazaieri H, Hahn KS, Gross JJ. Emotion regulation in social anxiety disorder: behavioral and neural responses to three socio-emotional tasks. Biol Mood Anxiety Disord. 2013 Nov 4;3(1):20. doi: 10.1186/2045-5380-3-20.
PubMed 24517388Goldin PR, Ziv M, Jazaieri H, Hahn K, Heimberg R, Gross JJ. Impact of cognitive behavioral therapy for social anxiety disorder on the neural dynamics of cognitive reappraisal of negative self-beliefs: randomized clinical trial. JAMA Psychiatry. 2013 Oct;70(10):1048-56. doi: 10.1001/jamapsychiatry.2013.234.
PubMed 23945981
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
- ClinicalTrials.gov ID
- NCT00380731
- Acronym / sponsor ID
- R01MH076074
- Conditions
- Social Phobia
- Keywords
- Social Anxiety Disorder, Magnetic Resonance Imaging, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Sep 2006 (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.
This study will evaluate the effect of cognitive behavioral therapy on the brain during emotional and behavioral responses to social stimuli in people with social phobia.
Detailed description
Social phobia, also known as social anxiety disorder, is a common, often debilitating condition. People with social phobia experience high levels of anxiety when they participate in social situations or perform in front of others. Approximately 80% of social phobia cases occur before the age of 18, and often precede other anxiety, mood, and substance abuse or dependence disorders. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment method for most people with social phobia. Approximately 30% of people with the disorder, however, do not respond to CBT treatment. A better understanding of the neural mechanisms underlying social phobia and CBT's effect on these mechanisms will help physicians to better predict the best treatment for different patients. This study will evaluate the effect of CBT on how the brain processes emotional and behavioral responses to social stimuli in people with social phobia.
Participants in this open-label study will be randomly assigned to either immediate or delayed treatment with CBT. Participants who are assigned to immediate CBT will attend 16 sessions of individual CBT immediately following baseline assessments. Participants assigned to the delayed treatment condition will begin attending CBT sessions approximately 5 months following baseline assessments. Outcomes will be assessed for all participants at baseline, immediately post-treatment, and at Months 5 and 10 post-treatment. An fMRI scan will be used to measure neural responses to social stimuli, and various questionnaires and scales will be used to assess anxiety symptom severity. Participants in the delayed treatment group will be assessed on one additional occasion before they begin treatment after the 5-month waiting period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Individual Cognitive Behavioral TherapyParticipants will receive immediate cognitive behavioral therapy |
| 2 | Experimental | Behavioral: Individual Cognitive Behavioral TherapyParticipants will receive cognitive behavioral therapy with a 16-week delayed start |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets DSM-IV criteria for generalized social phobia
- English-speaking
- Eligible to participate in fMRI scanning
- Willing to use an effective form of contraception throughout the study
Key exclusion criteria (9 listed)
- Currently undergoing any psychotherapy or pharmacotherapy (e.g, selective serotonin reuptake inhibitors, benzodiazepines, beta-blockers, anti-psychotics, blood thinners, thyroid hormone influencing agents, diabetic medications, or anticonvulsants)
- History of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, or head trauma with loss of consciousness for more than 5 minutes
- Smokes cigarettes daily
- History of or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, or schizoid personality disorders
- Suicidal thoughts
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 |
|---|---|---|
| Individual Cognitive Behavioral TherapyCBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder. | Behavioural | 1, 2 |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: Measured at Months 4, 7, 10, 13, and 16
fMRI BOLD response
Time frame: Measured at Month 4
Behavioral assessment
Time frame: Measured at Months 4 and 16
4 secondary outcomes
Clinical Global Impression Improvement Scale
Time frame: Measured at Months 4 and 16
Social Interaction Anxiety Scale
Time frame: Measured at Months 4, 10, and 16
Sheehan Disability Scale
Time frame: Measured at Months 4, 10, and 16
Quality of Life Inventory
Time frame: Measured at Months 4, 10, and 16
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 30 Nov 2011.
- Derived from this study: PubMed 38754336Morrison AS, Goldin PR, Gross JJ. Fear of negative and positive evaluation as mediators and moderators of treatment outcome in social anxiety disorder. J Anxiety Disord. 2024 Jun;104:102874. doi: 10.1016/j.janxdis.2024.102874. Epub 2024 May 1.
- Derived from this study: PubMed 31430688Butler RM, O'Day EB, Kaplan SC, Swee MB, Horenstein A, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Do sudden gains predict treatment outcome in social anxiety disorder? Findings from two randomized controlled trials. Behav Res Ther. 2019 Oct;121:103453. doi: 10.1016/j.brat.2019.103453. Epub 2019 Aug 9.
- Derived from this study: PubMed 25193002Goldin PR, Ziv M, Jazaieri H, Weeks J, Heimberg RG, Gross JJ. Impact of cognitive-behavioral therapy for social anxiety disorder on the neural bases of emotional reactivity to and regulation of social evaluation. Behav Res Ther. 2014 Nov;62:97-106. doi: 10.1016/j.brat.2014.08.005. Epub 2014 Aug 21.
- Derived from this study: PubMed 24632110Goldin PR, Lee I, Ziv M, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of change in emotion regulation and social anxiety during cognitive-behavioral therapy for social anxiety disorder. Behav Res Ther. 2014 May;56:7-15. doi: 10.1016/j.brat.2014.02.005. Epub 2014 Feb 28.
- Derived from this study: PubMed 24517388Ziv M, Goldin PR, Jazaieri H, Hahn KS, Gross JJ. Emotion regulation in social anxiety disorder: behavioral and neural responses to three socio-emotional tasks. Biol Mood Anxiety Disord. 2013 Nov 4;3(1):20. doi: 10.1186/2045-5380-3-20.
- Derived from this study: PubMed 23945981Goldin PR, Ziv M, Jazaieri H, Hahn K, Heimberg R, Gross JJ. Impact of cognitive behavioral therapy for social anxiety disorder on the neural dynamics of cognitive reappraisal of negative self-beliefs: randomized clinical trial. JAMA Psychiatry. 2013 Oct;70(10):1048-56. doi: 10.1001/jamapsychiatry.2013.234.
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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.
James J. Gross, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Cognitive Behavioral Therapy in people with Social Phobia, run by Stanford University 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 4 inclusion and 9 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 30 Nov 2011. 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.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (time frame: Measured at Months 4, 7, 10, 13, and 16). The study lists 3 primary outcomes in all. 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 NCT00380731, which also lists 6 linked publications.
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 30 Nov 2011.