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Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance- and commitment-based behavioral therapy
Cognitive behavioral therapy
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety, Social Anxiety Treatment, Cognitive Therapy, Mindfulness, Social Phobia, Social Phobia Treatment

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • UCLA Psychology Department - Franz Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Participants will receive standard cognitive behavioral therapy.

Participants will receive acceptance- and commitment-based behavioral therapy.

Participants will be placed on a waitlist for 3 months before being offered treatment.

Outcomes

Primary Outcome Measures

Brain activity, assessed using functional magnetic resonance imaging (fMRI)

Secondary Outcome Measures

Social anxiety symptoms

Full Information

First Posted
March 30, 2009
Last Updated
December 9, 2014
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00872820
Brief Title
Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder
Official Title
Neural Mediators of Behavior Therapy for Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety, Social Anxiety Treatment, Cognitive Therapy, Mindfulness, Social Phobia, Social Phobia Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive standard cognitive behavioral therapy.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive acceptance- and commitment-based behavioral therapy.
Arm Title
3
Arm Type
No Intervention
Arm Description
Participants will be placed on a waitlist for 3 months before being offered treatment.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance- and commitment-based behavioral therapy
Intervention Description
12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies
Primary Outcome Measure Information:
Title
Brain activity, assessed using functional magnetic resonance imaging (fMRI)
Time Frame
Measured at baseline and after 3 and 12 months
Secondary Outcome Measure Information:
Title
Social anxiety symptoms
Time Frame
Measured at baseline and after 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G. Craske, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Psychology Department - Franz Hall
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25022777
Citation
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.
Results Reference
derived

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Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder

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