NCT04048824

Brief Summary

The study will compare the effects that two different approaches of exposure therapy have on reducing fear and anxiety in individuals with social anxiety disorder or panic disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2015

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

9.4 years

First QC Date

November 26, 2018

Last Update Submit

April 3, 2025

Conditions

Keywords

inhibitory learningexposureanxietyhabituationsocial anxietypanic

Outcome Measures

Primary Outcomes (2)

  • Change in clinician-rated severity of social anxiety or panic disorder

    Clinician severity rating (0-8) of social anxiety or panic disorder using the Structured Clinical Interview for DSM-5 (SCID-5).

    Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)

  • Change in self-reported symptom severity of social anxiety or panic disorder

    Self-reported symptom severity of social anxiety disorder using the Liebowitz Social Anxiety Scale (LSAS) or panic disorder using the Panic Disorder Severity Scale-Self Report (PDSS-SR).

    Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)

Secondary Outcomes (11)

  • Change in fear extinction generalization as measured by expectancy of unconditional stimuli during conditional stimuli presentation.

    Pre-treatment to post-treatment (9 weeks)

  • Change in fear extinction generalization as measured by skin conductance.

    Pre-treatment to post-treatment (9 weeks)

  • Change in fear extinction generalization as measured by heart rate.

    Pre-treatment to post-treatment (10 weeks)

  • Implicit Fear Association Test

    Pre-treatment to post-treatment (10 weeks)

  • Behavioral Avoidance Test (BAT)

    Pre-treatment to post-treatment (10 weeks)

  • +6 more secondary outcomes

Study Arms (2)

Inhibitory Learning-Based Exposure

EXPERIMENTAL

Participants will receive exposure therapy aimed at increasing inhibitory learning.

Behavioral: Inhibitory Learning-Based Exposure

Habituation-Based Exposure

ACTIVE COMPARATOR

Participants will receive exposure therapy aimed at reducing fear responding.

Behavioral: Habituation-Based Exposure

Interventions

9 weekly treatment sessions conducted individually with a therapist. Exposure is focused on maximizing the mismatch between participant's feared outcome and what actually occurred (i.e., expectancy violation). This condition includes techniques that incorporate associative learning principles such as exposure to multiple feared stimuli (i.e., deepened extinction), exposure variability in contexts and stimuli, occasional reinforcement, and mental reinstatement of inhibitory learning.

Inhibitory Learning-Based Exposure

9 weekly treatment sessions conducted individually with a therapist. Exposure is focused on fear reduction from initial fear ratings. This condition includes theoretically-consistent techniques such as staying in the situation until fear declines, repetition of exposures until fear has declined, and a gradual approach to feared stimuli using an exposure hierarchy.

Habituation-Based Exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking treatment for social anxiety or panic disorder and demonstration of elevated scores using standardized self-report measures and diagnostic interview
  • Age 18 to 65
  • Either stabilized on psychotropic medications or medication-free
  • English-speaking
  • Access to telehealth resources (for Zoom treatment sessions after March 2020 due to COVID-19)

You may not qualify if:

  • Patient report of serious medical conditions - such as respiratory (e.g., chronic obstructive pulmonary disease), cardiovascular, pulmonary, neurological, muscular-skeletal diseases - or pregnancy
  • Active suicidal ideation or self-harm in the past year; history of suicide attempts in the last 10 years
  • History of bipolar disorder, psychosis, mental retardation or organic brain damage
  • Substance abuse/dependence within last 6 months
  • Concurrent therapy focused on anxiety. Participants are allowed to be in other forms of therapy, provided the therapy does not focus on anxiety (e.g., supportive counseling) and they have been stabilized on this alternative therapy for at least 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Phobia, SocialPanic DisorderAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental DisordersChemically-Induced Disorders

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
Principal Investigator

Study Record Dates

First Submitted

November 26, 2018

First Posted

August 7, 2019

Study Start

August 14, 2015

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations