Social Anxiety DisorderNCT02036658
Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
A study testing Cognitive Behavioral Group Therapy and Mindfulness-Based Stress Reduction in people with Social Anxiety Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Group Therapy and Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 1 Sep 2015
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
- aged 21-55
- working fluency in English
- residence in the Bay Area.
- eligible for fMRI scans (right-handed, no metal in body, etc.)
Who cannot join
- left-handed
- Medication use in the last 3 months
- Pervasive developmental disability
- acute suicide potential
- inability to travel to the treatment site
- schizophrenia or other psychotic disorder
Show all 10Show fewer
- history of bipolar disorder
- current primary Major Depression
- current substance dependence
- Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder.
Read the detailed description
- Aims
The overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (CR) and attention regulation (AR). CR and AR are thought to be important mechanisms underlying therapeutic change associated with Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) for generalized Social Anxiety Disorder (SAD). We seek to test whether changes in CR and AR underlie the therapeutic effects of CBT and MBSR, which have been shown in the clinical science literature to be effective treatments for SAD. We will examine CR and AR in healthy controls (HCs) and in participants with generalized SAD at baseline, as well as in participants with SAD after they have completed a randomized controlled trial (RCT) with three treatment arms: CBT, MBSR, or Waitlist (WL). This work will address 3 aims: Aim 1 will examine the efficacy of CR and AR in individuals with SAD versus HCs; Aim 2 will investigate the immediate and longer-term impact of CBT versus MBSR for SAD; and Aim 3 will examine treatment-related changes in CR and AR and test whether these changes mediate the effects of CBT versus MBSR. The broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from SAD, as well as a wide range of other anxiety and mood disorders.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Behavioral Group Therapy, Mindfulness-Based Stress Reduction
- Keywords
- social anxiety, treatment, cognitive-behavioral therapy, mindfulness-based stress reduction, emotion regulation, randomized controlled trial, neuroimaging, functional magnetic resonance imaging, mediators, mechanisms
- Medical subject headings
- Phobia, Social, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
Also called CBGT
Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
Mindfulness-Based Stress Reduction will be completed in 12 weeks in the study and includes enhancing one's awareness non-judgmentally by focusing on the present moment through the use of mindfulness meditation.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Group Therapy | Active comparator | Cognitive behavioral group therapy (CBGT) will be delivered by two Ph.D. clinical psychologists trained by Dr. Richard Heimberg to implement his CBGT for SAD (Heimberg \& Becker, 2002). Groups of six individuals will meet for 12 sessions of 2.5 hours each. The participants will also use selected portions of the client workbook developed by (Hope, Heimberg, \& Turk, 2010) to supplement relevant portions of the protocol. The treatment will be comprised of four major components: (1) psychoeducation and orientation to CBGT; (2) cognitive restructuring skills; (3) graduated exposure to feared social situations, within session and as homework; and (4) relapse prevention and termination. Further details of the treatment are available elsewhere (Heimberg \& Becker, 2002). Receives: Behavioral: Cognitive Behavioral Group Therapy |
| Mindfulness-Based Stress Reduction | Active comparator | MBSR will follow the standard curriculum outline compiled in 1993 by Jon Kabat-Zinn except that the one-day meditation retreat will be converted to four additional weekly group sessions between the standard class 6 and 7 so that there will be 12 weekly 2.5 hour sessions. This will be done to match the CBGT protocol in duration and time. The MBSR intervention will be delivered by a University of Massachusetts Center for Mindfulness certified MBSR instructor with more than 30 years of teaching experience. To support the practice, each participant will be given A Mindfulness-Based Stress Reduction Workbook (Stahl \& Goldstein, 2010), which includes descriptions of mindfulness exercises together with pre-recorded audio files to support ongoing practice. Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Waitlist Control | No intervention | This will be a delayed treatment arm. Participants randomized to the waitlist control group will be re-randomized after completing the no treatment period of 12 weeks to CBGT or MBSR with equal probability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Liebowitz Social Anxiety Scale (LSAS)
The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire which assesses the severity of social anxiety symptoms (Fresco et al., 2001; Liebowitz, 1987). Respondents are asked to rate their level of fear and avoidance to 11 social interaction situations and 13 performance situations. A 4-point Likert-type scale is used for ratings of fear and of avoidance, with a range from 0 (none and never, respectively) to 3 (severe and usually, respectively) for each situation during the past week. Ratings are summed for a total LSAS-SR score (range 0 to 144). The LSAS-SR has demonstrated good reliability and construct validity (Rytwinski et al., 2009).
Measured: from baseline to 1- year following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMar 2011
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies 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
- Model description
- To investigate treatment outcome and mediators of Cognitive-Behavioral Group Therapy (CBGT) vs. Mindfulness-Based Stress Reduction (MBSR) vs. Waitlist (WL) in patients with generalized social anxiety disorder (SAD), unmedicated patients with a primary diagnosis of Social Anxiety Disorder (SAD) will be randomized to CBGT vs. MBSR vs. WL and will complete assessments at baseline, post-treatment/WL, and at 1-year follow-up, including the Liebowitz Social Anxiety Scale - Self-Report (primary outcome; Liebowitz, 1987) as well as measures of treatment-related processes.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 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 UniversityPhilippe R. Goldin, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036658
- Sponsor's protocol ID
- CBT-MBSR 10521038
- Other IDs
- R01MH076074
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
PubMed 2885745Heimberg RG, Becker RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press; 2002.
Hope DA, Heimberg RG, Turk CL. Managing social anxiety: A cognitive-behavioral therapy approach. Treatments That Work; 2010.
Kabat-Zinn J. Mindfulness meditation: Health benefits of an ancient Buddhist practice. In D. Goleman & J. Gurin (Eds.), Mind/Body Medicine (pp. 259-275). Yonkers, NY: Consumer Reports Books, 1993.
Stahl B, Goldstein E. A mindfulness-based stress reduction workbook. New Harbinger Publications; 2010 Mar 1.
American Psychiatric Association. Diagnostic and statistical manual, 4th edn, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington. 2000.
Goldin PR, Morrison A, Jazaieri H, Brozovich F, Heimberg R, Gross JJ. Group CBT versus MBSR for social anxiety disorder: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):427-37. doi: 10.1037/ccp0000092. Epub 2016 Mar 7.
PubMed 26950097Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06.001. Epub 2017 Jun 3.
PubMed 28654771Morrison 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 38754336Morrison AS, Ustun B, Horenstein A, Kaplan SC, de Oliveira IR, Batmaz S, Gross JJ, Sadikova E, Hemanny C, Pires PP, Goldin PR, Kessler RC, Heimberg RG. Optimized short-forms of the Cognitive Distortions Questionnaire. J Anxiety Disord. 2022 Dec;92:102624. doi: 10.1016/j.janxdis.2022.102624. Epub 2022 Aug 20.
PubMed 36087565Goldin PR, Thurston M, Allende S, Moodie C, Dixon ML, Heimberg RG, Gross JJ. Evaluation of Cognitive Behavioral Therapy vs Mindfulness Meditation in Brain Changes During Reappraisal and Acceptance Among Patients With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1134-1142. doi: 10.1001/jamapsychiatry.2021.1862.
PubMed 34287622Kuo JR, Zeifman RJ, Morrison AS, Heimberg RG, Goldin PR, Gross JJ. The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. J Affect Disord. 2021 Apr 15;285:127-135. doi: 10.1016/j.jad.2021.02.022. Epub 2021 Feb 8.
PubMed 33647580O'Day EB, Butler RM, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder. J Anxiety Disord. 2021 Mar;78:102362. doi: 10.1016/j.janxdis.2021.102362. Epub 2021 Jan 17.
PubMed 33486385Butler 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 31430688Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.
PubMed 31082285
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
- fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02036658
- Acronym / sponsor ID
- CBT-MBSR 10521038
- Conditions
- Social Anxiety Disorder
- Keywords
- social anxiety, treatment, cognitive-behavioral therapy, mindfulness-based stress reduction, emotion regulation, randomized controlled trial, neuroimaging, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2011
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 15 Jan 2014 (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.
The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder.
Detailed description
- Aims
The overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (CR) and attention regulation (AR). CR and AR are thought to be important mechanisms underlying therapeutic change associated with Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) for generalized Social Anxiety Disorder (SAD). We seek to test whether changes in CR and AR underlie the therapeutic effects of CBT and MBSR, which have been shown in the clinical science literature to be effective treatments for SAD. We will examine CR and AR in healthy controls (HCs) and in participants with generalized SAD at baseline, as well as in participants with SAD after they have completed a randomized controlled trial (RCT) with three treatment arms: CBT, MBSR, or Waitlist (WL). This work will address 3 aims: Aim 1 will examine the efficacy of CR and AR in individuals with SAD versus HCs; Aim 2 will investigate the immediate and longer-term impact of CBT versus MBSR for SAD; and Aim 3 will examine treatment-related changes in CR and AR and test whether these changes mediate the effects of CBT versus MBSR. The broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from SAD, as well as a wide range of other anxiety and mood disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- To investigate treatment outcome and mediators of Cognitive-Behavioral Group Therapy (CBGT) vs. Mindfulness-Based Stress Reduction (MBSR) vs. Waitlist (WL) in patients with generalized social anxiety disorder (SAD), unmedicated patients with a primary diagnosis of Social Anxiety Disorder (SAD) will be randomized to CBGT vs. MBSR vs. WL and will complete assessments at baseline, post-treatment/WL, and at 1-year follow-up, including the Liebowitz Social Anxiety Scale - Self-Report (primary outcome; Liebowitz, 1987) as well as measures of treatment-related processes.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Group Therapy | Active comparator | Behavioral: Cognitive Behavioral Group TherapyCognitive behavioral group therapy (CBGT) will be delivered by two Ph.D. clinical psychologists trained by Dr. Richard Heimberg to implement his CBGT for SAD (Heimberg \& Becker, 2002). Groups of six individuals will meet for 12 sessions of 2.5 hours each. The participants will also use selected portions of the client workbook developed by (Hope, Heimberg, \& Turk, 2010) to supplement relevant portions of the protocol. The treatment will be comprised of four major components: (1) psychoeducation and orientation to CBGT; (2) cognitive restructuring skills; (3) graduated exposure to feared social situations, within session and as homework; and (4) relapse prevention and termination. Further details of the treatment are available elsewhere (Heimberg \& Becker, 2002). |
| Mindfulness-Based Stress Reduction | Active comparator | Behavioral: Mindfulness-Based Stress ReductionMBSR will follow the standard curriculum outline compiled in 1993 by Jon Kabat-Zinn except that the one-day meditation retreat will be converted to four additional weekly group sessions between the standard class 6 and 7 so that there will be 12 weekly 2.5 hour sessions. This will be done to match the CBGT protocol in duration and time. The MBSR intervention will be delivered by a University of Massachusetts Center for Mindfulness certified MBSR instructor with more than 30 years of teaching experience. To support the practice, each participant will be given A Mindfulness-Based Stress Reduction Workbook (Stahl \& Goldstein, 2010), which includes descriptions of mindfulness exercises together with pre-recorded audio files to support ongoing practice. |
| Waitlist Control | No intervention | –This will be a delayed treatment arm. Participants randomized to the waitlist control group will be re-randomized after completing the no treatment period of 12 weeks to CBGT or MBSR with equal probability. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
- aged 21-55
- working fluency in English
- residence in the Bay Area.
- eligible for fMRI scans (right-handed, no metal in body, etc.)
Key exclusion criteria (10 listed)
- left-handed
- Medication use in the last 3 months
- Pervasive developmental disability
- acute suicide potential
- inability to travel to the treatment site
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 Behavioral Group TherapyAlso: CBGTCognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations. | Behavioural | Cognitive Behavioral Group Therapy |
| Mindfulness-Based Stress ReductionAlso: MBSRMindfulness-Based Stress Reduction will be completed in 12 weeks in the study and includes enhancing one's awareness non-judgmentally by focusing on the present moment through the use of mindfulness meditation. | Behavioural | Mindfulness-Based Stress Reduction |
Primary outcome
Changes in Liebowitz Social Anxiety Scale (LSAS)
Time frame: from baseline to 1- year following treatment
The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire which assesses the severity of social anxiety symptoms (Fresco et al., 2001; Liebowitz, 1987). Respondents are asked to rate their level of fear and avoidance to 11 social interaction situations and 13 performance situations. A 4-point Likert-type scale is used for ratings of fear and of avoidance, with a range from 0 (none and never, respectively) to 3 (severe and usually, respectively) for each situation during the past week. Ratings are summed for a total LSAS-SR score (range 0 to 144). The LSAS-SR has demonstrated good reliability and construct validity (Rytwinski et al., 2009).
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.
- Background: PubMed 2885745Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
- BackgroundHeimberg RG, Becker RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press; 2002.
- BackgroundHope DA, Heimberg RG, Turk CL. Managing social anxiety: A cognitive-behavioral therapy approach. Treatments That Work; 2010.
- BackgroundKabat-Zinn J. Mindfulness meditation: Health benefits of an ancient Buddhist practice. In D. Goleman & J. Gurin (Eds.), Mind/Body Medicine (pp. 259-275). Yonkers, NY: Consumer Reports Books, 1993.
- BackgroundStahl B, Goldstein E. A mindfulness-based stress reduction workbook. New Harbinger Publications; 2010 Mar 1.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual, 4th edn, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington. 2000.
- Results publication: PubMed 26950097Goldin PR, Morrison A, Jazaieri H, Brozovich F, Heimberg R, Gross JJ. Group CBT versus MBSR for social anxiety disorder: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):427-37. doi: 10.1037/ccp0000092. Epub 2016 Mar 7.
- Results publication: PubMed 28654771Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06.001. Epub 2017 Jun 3.
- 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 36087565Morrison AS, Ustun B, Horenstein A, Kaplan SC, de Oliveira IR, Batmaz S, Gross JJ, Sadikova E, Hemanny C, Pires PP, Goldin PR, Kessler RC, Heimberg RG. Optimized short-forms of the Cognitive Distortions Questionnaire. J Anxiety Disord. 2022 Dec;92:102624. doi: 10.1016/j.janxdis.2022.102624. Epub 2022 Aug 20.
- Derived from this study: PubMed 34287622Goldin PR, Thurston M, Allende S, Moodie C, Dixon ML, Heimberg RG, Gross JJ. Evaluation of Cognitive Behavioral Therapy vs Mindfulness Meditation in Brain Changes During Reappraisal and Acceptance Among Patients With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1134-1142. doi: 10.1001/jamapsychiatry.2021.1862.
- Derived from this study: PubMed 33647580Kuo JR, Zeifman RJ, Morrison AS, Heimberg RG, Goldin PR, Gross JJ. The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. J Affect Disord. 2021 Apr 15;285:127-135. doi: 10.1016/j.jad.2021.02.022. Epub 2021 Feb 8.
- Individual participant dataSharing planned: No
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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
Philippe R. Goldin, PhD study director
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 Cognitive Behavioral Group Therapy and Mindfulness-Based Stress Reduction in people with Social Anxiety Disorder, 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 5 inclusion and 10 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.
What does the primary outcome measure?
Changes in Liebowitz Social Anxiety Scale (LSAS) (time frame: from baseline to 1- year following treatment). 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 NCT02036658, which also lists 17 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 18 Jan 2018.