NCT00872820

Brief Summary

This study will compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

4.9 years

First QC Date

March 30, 2009

Last Update Submit

December 9, 2014

Conditions

Keywords

Social AnxietySocial Anxiety TreatmentCognitive TherapyMindfulnessSocial PhobiaSocial Phobia Treatment

Outcome Measures

Primary Outcomes (1)

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

    Measured at baseline and after 3 and 12 months

Secondary Outcomes (1)

  • Social anxiety symptoms

    Measured at baseline and after 3, 6, and 12 months

Study Arms (3)

1

ACTIVE COMPARATOR

Participants will receive standard cognitive behavioral therapy.

Behavioral: Cognitive behavioral therapy

2

EXPERIMENTAL

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

Behavioral: Acceptance- and commitment-based behavioral therapy

3

NO INTERVENTION

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

Interventions

12 weekly treatment sessions conducted individually with a therapist; strategies for dealing with anxiety will include mindfulness and acceptance of negative feelings

2

12 weekly treatment sessions conducted individually with a therapist; methods for dealing with anxiety will include cognitive and breathing strategies

1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Psychology Department - Franz Hall

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michelle G. Craske, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations