NCT02163148

Brief Summary

Anxiety disorders are common and impairing. Although exposure therapy is one of the most effective treatments for anxiety, some individuals do not fully respond to treatment, and these individual differences are not well understood. Exposure therapy involves repeated, deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This treatment is thought to work through a type of emotional learning called fear extinction. This study aims to look at links between fear extinction learning and exposure success, with the overall goal of better understanding who is likely to respond best to exposure therapy and why.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

June 11, 2014

Last Update Submit

May 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure

    Participants will complete 4 exposures during one 90 minute session. Change in the peak ratings on the final exposure relative to the first exposure will be the outcome measure.

    90 minutes

Secondary Outcomes (2)

  • Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks

    Baseline, week 2

  • Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks

    Baseline, week 2

Other Outcomes (1)

  • Change from baseline on the Sheehan Disability Scale (SDS) at week 2

    Baseline, week 2

Study Arms (1)

Public Speaking Anxiety

Intervention to be administered: One speech exposure session.

Behavioral: Massed speech exposure session

Interventions

One session consisting of 4 speech exposures, each 5 minutes long.

Public Speaking Anxiety

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Score of at least 20 on the PRCS
  • Age 18-55
  • English fluency

You may not qualify if:

  • Psychotropic medication use in the past 4 weeks
  • Past experience with exposure based therapy
  • History of bipolar disorder, psychotic disorder, or substance dependence
  • Current major depressive disorder of greater than moderate severity (defined as a score on the 9 item Patient Health Questionnaire of greater than 14)
  • Clinically significant suicidal or homicidal ideation
  • Non-removable ferrous metal
  • Current significant neurological conditions
  • History of loss of consciousness greater than 5 minutes duration
  • Pregnant
  • Claustrophobic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Psychiatry Research

San Diego, California, 92037, United States

Location

Related Publications (1)

  • Ball TM, Knapp SE, Paulus MP, Stein MB. Brain activation during fear extinction predicts exposure success. Depress Anxiety. 2017 Mar;34(3):257-266. doi: 10.1002/da.22583. Epub 2016 Dec 6.

Study Officials

  • Tali M Ball, MA

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 13, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations