Social Anxiety DisorderNCT00872820
Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
A study testing Acceptance- and commitment-based behavioral therapy and Cognitive behavioral therapy in people with Social Anxiety Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Acceptance- and commitment-based behavioral therapy and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2013
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets diagnostic criteria for social anxiety disorder
- Right-handed
- If taking medications, stabilized on current dose for 3 months
- If undergoing psychotherapy, stabilized for 6 months
- Speaks English
Who cannot join
- Currently undergoing cognitive behavioral therapy
- History of psychiatric hospitalization in the last 5 years
- Presence of serious medical condition, such as respiratory, cardiovascular, pulmonary, neurological, or muscular-skeletal disease or pregnancy
- Active suicidal ideation
- Current severe depression
- History of bipolar disorder, psychosis, mental retardation, or brain damage
Show all 9Show fewer
- History of substance abuse or dependence in the last 6 months
- Presence of irremovable metal objects in the body that are not fMRI-safe
- Suffers from claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Psychology Department - Franz Hall
Los Angeles, California, 90095
About this study
Official title: Neural Mediators of Behavior Therapy for Anxiety
This study will compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder.
Read the detailed description
Social anxiety disorder (SAD) is characterized by intense and debilitating anxiety in common social situations. Cognitive behavioral therapy (CBT) is a talking treatment that aims to reduce immediate anxiety symptoms. However, some anxiety symptoms and comorbid disorders not directly addressed by CBT may only improve in the short term, while recurring in the long term. Behavioral therapy based on acceptance and mindfulness is thought to have longer lasting effects, because this approach emphasizes accepting anxiety instead of controlling anxiety. This study will compare standard CBT to acceptance and commitment therapy (ACT), which uses acceptance and mindfulness, to determine which is more effective on both a short- and long-term basis. Participants with SAD will undergo brain scans to determine how the two therapies affect brain functioning.
Participation in this study will last 12 months. Participants with SAD will be randomly assigned to receive CBT, ACT, or a waitlist condition. Both CBT and ACT treatments will include 12 weekly sessions that will deal with objects and situations that provoke anxiety. All sessions will be audio- and videotaped. The waitlist group will complete weekly self-monitoring forms to track anxiety and panic and will receive a phone call from a research coordinator every 2 weeks to make sure symptoms have not worsened. After 12 weeks, participants on the waitlist will be offered treatment.
All participants will attend study visits to undergo brain scanning at baseline, after 3 months, and after 12 months. Each study visit will involve MRI scanning (to evaluate brain structure), functional MRI (fMRI) scanning (to evaluate brain function), questionnaires about a participant's experience in the scanner, and collection of saliva samples before, during, and after scanning. While undergoing the fMRI scan, participants will be asked to remain at rest for a certain period of time, and then to perform tasks that will engage certain parts of the brain. Assessments for all participants will occur at baseline and after 3, 6, and 12 months. These assessments will include diagnostic evaluations by a therapist, self-report questionnaires, ongoing self-monitoring, physiological measurements, cognitive assessments, and behavioral observation.
- Conditions
- Social Anxiety Disorder
- Being tested
- Acceptance- and commitment-based behavioral therapy, Cognitive behavioral therapy
- Keywords
- Social Anxiety, Social Anxiety Treatment, Cognitive Therapy, Mindfulness, Social Phobia, Social Phobia Treatment
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance- and commitment-based behavioral therapyBehavioural
12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings
Cognitive behavioral therapyBehavioural
12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive standard cognitive behavioral therapy. Receives: Behavioral: Cognitive behavioral therapy |
| 2 | Experimental | Participants will receive acceptance- and commitment-based behavioral therapy. Receives: Behavioral: Acceptance- and commitment-based behavioral therapy |
| 3 | No intervention | Participants will be placed on a waitlist for 3 months before being offered treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity, assessed using functional magnetic resonance imaging (fMRI)
Measured: Measured at baseline and after 3 and 12 months
Secondary outcomes (1)
Social anxiety symptoms
Measured: Measured at baseline and after 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2013
- Study completionSep 2013
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 Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
- Investigators
- Michelle G. Craske, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872820
- Sponsor's protocol ID
- R21MH081299
- Other IDs
- R21MH081299, DATR A3-NSS
- Status last verified
- Dec 2014
- First submitted
- 30 Mar 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Niles AN, Burklund LJ, Arch JJ, Lieberman MD, Saxbe D, Craske MG. Cognitive mediators of treatment for social anxiety disorder: comparing acceptance and commitment therapy and cognitive-behavioral therapy. Behav Ther. 2014 Sep;45(5):664-77. doi: 10.1016/j.beth.2014.04.006. Epub 2014 May 5.
PubMed 25022777
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mediators of Behavior Therapy for Anxiety
- ClinicalTrials.gov ID
- NCT00872820
- Acronym / sponsor ID
- R21MH081299
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety, Social Anxiety Treatment, Cognitive Therapy, Mindfulness, Social Phobia, Social Phobia Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 Mar 2009 (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 compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder.
Detailed description
Social anxiety disorder (SAD) is characterized by intense and debilitating anxiety in common social situations. Cognitive behavioral therapy (CBT) is a talking treatment that aims to reduce immediate anxiety symptoms. However, some anxiety symptoms and comorbid disorders not directly addressed by CBT may only improve in the short term, while recurring in the long term. Behavioral therapy based on acceptance and mindfulness is thought to have longer lasting effects, because this approach emphasizes accepting anxiety instead of controlling anxiety. This study will compare standard CBT to acceptance and commitment therapy (ACT), which uses acceptance and mindfulness, to determine which is more effective on both a short- and long-term basis. Participants with SAD will undergo brain scans to determine how the two therapies affect brain functioning.
Participation in this study will last 12 months. Participants with SAD will be randomly assigned to receive CBT, ACT, or a waitlist condition. Both CBT and ACT treatments will include 12 weekly sessions that will deal with objects and situations that provoke anxiety. All sessions will be audio- and videotaped. The waitlist group will complete weekly self-monitoring forms to track anxiety and panic and will receive a phone call from a research coordinator every 2 weeks to make sure symptoms have not worsened. After 12 weeks, participants on the waitlist will be offered treatment.
All participants will attend study visits to undergo brain scanning at baseline, after 3 months, and after 12 months. Each study visit will involve MRI scanning (to evaluate brain structure), functional MRI (fMRI) scanning (to evaluate brain function), questionnaires about a participant's experience in the scanner, and collection of saliva samples before, during, and after scanning. While undergoing the fMRI scan, participants will be asked to remain at rest for a certain period of time, and then to perform tasks that will engage certain parts of the brain. Assessments for all participants will occur at baseline and after 3, 6, and 12 months. These assessments will include diagnostic evaluations by a therapist, self-report questionnaires, ongoing self-monitoring, physiological measurements, cognitive assessments, and behavioral observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Cognitive behavioral therapyParticipants will receive standard cognitive behavioral therapy. |
| 2 | Experimental | Behavioral: Acceptance- and commitment-based behavioral therapyParticipants will receive acceptance- and commitment-based behavioral therapy. |
| 3 | No intervention | –Participants will be placed on a waitlist for 3 months before being offered treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meets diagnostic criteria for social anxiety disorder
- Right-handed
- If taking medications, stabilized on current dose for 3 months
- If undergoing psychotherapy, stabilized for 6 months
- Speaks English
Key exclusion criteria (9 listed)
- Currently undergoing cognitive behavioral therapy
- History of psychiatric hospitalization in the last 5 years
- Presence of serious medical condition, such as respiratory, cardiovascular, pulmonary, neurological, or muscular-skeletal disease or pregnancy
- Active suicidal ideation
- Current severe depression
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 |
|---|---|---|
| Acceptance- and commitment-based behavioral therapy12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings | Behavioural | 2 |
| Cognitive behavioral therapy12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies | Behavioural | 1 |
Primary outcome
Brain activity, assessed using functional magnetic resonance imaging (fMRI)
Time frame: Measured at baseline and after 3 and 12 months
1 secondary outcome
Social anxiety symptoms
Time frame: Measured at baseline and after 3, 6, and 12 months
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 Dec 2014.
- Derived from this study: PubMed 25022777Niles AN, Burklund LJ, Arch JJ, Lieberman MD, Saxbe D, Craske MG. Cognitive mediators of treatment for social anxiety disorder: comparing acceptance and commitment therapy and cognitive-behavioral therapy. Behav Ther. 2014 Sep;45(5):664-77. doi: 10.1016/j.beth.2014.04.006. Epub 2014 May 5.
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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.
Michelle G. Craske, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance- and commitment-based behavioral therapy and Cognitive behavioral therapy in people with Social Anxiety Disorder, run by University of California, Los Angeles 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 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 11 Dec 2014. 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?
Brain activity, assessed using functional magnetic resonance imaging (fMRI) (time frame: Measured at baseline and after 3 and 12 months). 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 NCT00872820, 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 Dec 2014.