Using the Neuroscience of Fear Extinction for Anxiety Reduction

NCT03465137 | Terminated

• 1 other identifier: IRB-44722
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Social anxiety disorder affects as many as 12% of Americans, resulting in significant distress and disability. Although exposure therapy is one of the best treatments available, as many as 25% of patients do not respond and we do not know why. Extinction learning is thought to be the mechanism of exposure therapy, and the neuroscience of extinction learning has advanced significantly since exposure therapy was developed; however, there has been little application towards improved clinical outcomes. This project aims to improve exposure therapy response for patients with social anxiety disorder by directly linking exposure therapy response to the neurobiology of extinction learning. It also aims to increase our scientific understanding of how brain circuits work to support extinction learning. To do this, 80 adults with social anxiety disorder will randomly be assigned to either receive exposure therapy right away, or to wait before therapy. Participants will all complete a functional magnetic resonance imaging scan to assess extinction learning before the therapy.

Conditions

Social Anxiety

Keywords

Exposure therapy; Behavioral therapy; fMRI; Extinction learning; Social anxiety

Outcome Measures

Primary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  A validated, widely-used measure of social anxiety severity, with anxiety and avoidance subscales. Subscales range from 0 to 72, with higher scores indicating greater anxiety and avoidance symptoms. A total score is computed by summing the two subscales (range: 0 to 144, higher scores indicate greater social anxiety severity).

  12 weeks

Secondary Outcomes (3)

• Patient Health Questionnaire (PHQ-9)

  12 weeks

• Brief Fear of Negative Evaluation (BFNE)

  12 weeks

• World Health Organization Quality of Life scale (WHO-QOL)

  12 weeks

Study Arms (2)

Immediate therapy

EXPERIMENTAL

Participants randomized to the immediate therapy arm will receive a weekly individual psychotherapy intervention called Coordinated Anxiety Learning and Management (CALM). The CALM program is an evidence based, exposure-focused therapy (http://calmtoolsforliving.org). Its computer-assisted format guides the therapist through psychoeducation, an introduction to cognitive restructuring, in-session and at-home exposures, and relapse prevention. Therapy will be delivered in 10 weekly 50-minute sessions within a 12 week period.

Behavioral: Coordinated Anxiety Learning and Management (CALM)

Waitlist

NO INTERVENTION

Participants randomized to the waitlist arm will receive no intervention for 12 weeks. After this 12 week period they will receive a the same weekly individual psychotherapy intervention as the immediate therapy group: Coordinated Anxiety Learning and Management (CALM). The CALM program is an evidence based, exposure-focused therapy (http://calmtoolsforliving.org). Its computer-assisted format guides the therapist through psychoeducation, an introduction to cognitive restructuring, in-session and at-home exposures, and relapse prevention. Therapy will be delivered in 10 weekly 50-minute sessions within a 12 week period.

Interventions

Coordinated Anxiety Learning and Management (CALM) BEHAVIORAL

Exposure-focused cognitive behavioral therapy

Immediate therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-50
• primary diagnosis of social anxiety disorder
• fluent spoken and written English
• able to provide informed consent.

You may not qualify if:

• history of mania or psychosis
• current moderate or severe substance use disorder
• current major depression greater than moderate severity
• high risk for suicide
• prior traumatic brain injury with loss of consciousness \>5 minutes
• general medical condition or impediment to vision, hearing, or motor function likely to interfere with assessments
• prior exposure therapy (\>2 sessions)
• current use of psychotropic medication
• current psychotherapy other than couples counseling
• post-menopausal status
• pregnancy

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Department of Psychiatry & Behavioral Sciences

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Therapeutics

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: Postdoctoral Scholar

Model Details: Immediate therapy versus waitlist arms

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: January 14, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: We anticipate uploading the final research data of all consenting participants no later than 5 years after the completion of the study.

Locations

US (1)