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Optimizing Exposure Therapy for Anxiety Disorders (OptEx)

Primary Purpose

Social Anxiety Disorder, Panic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhibitory Learning-Based Exposure
Habituation-Based Exposure
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 inhibitory learning, exposure, anxiety, habituation, social anxiety, panic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion criteria include:

  1. Patient report of serious medical conditions - such as respiratory (e.g., chronic obstructive pulmonary disease), cardiovascular, pulmonary, neurological, muscular-skeletal diseases - or pregnancy
  2. Active suicidal ideation or self-harm in the past year; history of suicide attempts in the last 10 years
  3. History of bipolar disorder, psychosis, mental retardation or organic brain damage
  4. Substance abuse/dependence within last 6 months
  5. 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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhibitory Learning-Based Exposure

Habituation-Based Exposure

Arm Description

Participants will receive exposure therapy aimed at increasing inhibitory learning.

Participants will receive exposure therapy aimed at reducing fear responding.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Change in fear extinction generalization as measured by expectancy of unconditional stimuli during conditional stimuli presentation.
Change in responsiveness to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm.
Change in fear extinction generalization as measured by skin conductance.
Change in skin conductance to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm. (Discontinued March 2020 due to COVID-19)
Change in fear extinction generalization as measured by heart rate.
Change in heart rate to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm. (Discontinued March 2020 due to COVID-19)
Implicit Fear Association Test
Change in implicit associations for fear-relevant word stimuli
Behavioral Avoidance Test (BAT)
Change in duration and subjective fear of public speaking in situ
Probability and Cost Questionnaire
Change in perceived likelihood and perceived consequence of fear-relevant outcomes
Anxiety Sensitivity Index (ASI-3)
Change in appraisal of harmfulness of symptoms
Positive and Negative Affect Schedule (PANAS 20 item)
Change in affect
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Change in panic disorder symptoms
Mini-SPIN
Change in social anxiety symptoms
Sheehan Disability Scale (SDS)
Change in functioning related to mental health

Full Information

First Posted
November 26, 2018
Last Updated
May 5, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04048824
Brief Title
Optimizing Exposure Therapy for Anxiety Disorders
Acronym
OptEx
Official Title
Inhibitory Learning vs. Habituation: Models of Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2015 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
A substantial number of individuals fail to achieve clinically significant symptom relief from exposure-based therapies or experience a return of fear following exposure therapy completion. The prevailing model of exposure therapy for phobias and anxiety disorders purports that fear reduction throughout exposure therapy (i.e., habituation) is reflective of learning and critical to overall therapeutic outcome. However, the amount by which fear - indexed by both self-report, behavioral, and biological correlates of fear expression - reduces by the end of an exposure trial or series of exposure trials is not a reliable predictor of the fear level expressed at follow-up assessment. Developments in the theory and science of fear extinction, and learning and memory, indicate that 'performance during training' is not commensurate with learning at the process level. Inconsistent findings regarding fear reduction are paralleled by findings based in associative learning laboratory paradigms with animals and human samples, specifically that outward expression of fear on the one hand, and conditional associations indicative of underlying learning on the other hand, may not always change in concordance. Rather, 'inhibitory learning' is recognized as being central to extinction, rather than fear during extinction training. The current proposal will compare the habituation-based model of exposure therapy to the competing inhibitory model of exposure that emphasizes learning theory principles. The current study plans to recruit participants for a treatment trial consisting of two psychotherapies: (a) habituation-based exposure therapy and (b) inhibitory learning-based exposure therapy. The primary goal of this study is to determine if one theoretical approach to exposure outperforms the other in reducing symptoms. This study is conducted with individuals meeting diagnostic criteria for social anxiety disorder or panic disorder. Participants will be randomized to either treatment condition and receive 9 sessions of individual psychotherapy focused on either of these disorders. If individual meets diagnostic criteria for both disorders, treatment will be focused on the primary presenting disorder. Participants will complete four assessments over the course of the study, at pre-treatment, mid-treatment, post-treatment, and three-month follow-up. Pre-treatment, mid-treatment, and post-treatment assessments occur over two days, while three-month follow-up requires only a single day and is conducted remotely. These assessments will include semi-structured interviews, self-report questionnaires, and laboratory paradigms designed to examine fear learning processes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Panic Disorder
Keywords
inhibitory learning, exposure, anxiety, habituation, social anxiety, panic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Inhibitory Learning-Based Exposure
Arm Type
Experimental
Arm Description
Participants will receive exposure therapy aimed at increasing inhibitory learning.
Arm Title
Habituation-Based Exposure
Arm Type
Active Comparator
Arm Description
Participants will receive exposure therapy aimed at reducing fear responding.
Intervention Type
Behavioral
Intervention Name(s)
Inhibitory Learning-Based Exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Habituation-Based Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in clinician-rated severity of social anxiety or panic disorder
Description
Clinician severity rating (0-8) of social anxiety or panic disorder using the Structured Clinical Interview for DSM-5 (SCID-5).
Time Frame
Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
Title
Change in self-reported symptom severity of social anxiety or panic disorder
Description
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).
Time Frame
Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
Secondary Outcome Measure Information:
Title
Change in fear extinction generalization as measured by expectancy of unconditional stimuli during conditional stimuli presentation.
Description
Change in responsiveness to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm.
Time Frame
Pre-treatment to post-treatment (9 weeks)
Title
Change in fear extinction generalization as measured by skin conductance.
Description
Change in skin conductance to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm. (Discontinued March 2020 due to COVID-19)
Time Frame
Pre-treatment to post-treatment (9 weeks)
Title
Change in fear extinction generalization as measured by heart rate.
Description
Change in heart rate to fear generalized from various, perceptually similar stimuli collected during a laboratory fear paradigm. (Discontinued March 2020 due to COVID-19)
Time Frame
Pre-treatment to post-treatment (10 weeks)
Title
Implicit Fear Association Test
Description
Change in implicit associations for fear-relevant word stimuli
Time Frame
Pre-treatment to post-treatment (10 weeks)
Title
Behavioral Avoidance Test (BAT)
Description
Change in duration and subjective fear of public speaking in situ
Time Frame
Pre-treatment to post-treatment (10 weeks)
Title
Probability and Cost Questionnaire
Description
Change in perceived likelihood and perceived consequence of fear-relevant outcomes
Time Frame
Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Title
Anxiety Sensitivity Index (ASI-3)
Description
Change in appraisal of harmfulness of symptoms
Time Frame
Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Title
Positive and Negative Affect Schedule (PANAS 20 item)
Description
Change in affect
Time Frame
Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Title
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Description
Change in panic disorder symptoms
Time Frame
Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Title
Mini-SPIN
Description
Change in social anxiety symptoms
Time Frame
Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Title
Sheehan Disability Scale (SDS)
Description
Change in functioning related to mental health
Time Frame
Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion criteria include: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Ruiz, BA
Phone
(562) 459-4938
Email
jruiz@psych.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Cullen, BA
Email
brookecullen@psych.ucla.edu
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
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Sewart, MA

12. IPD Sharing Statement

Learn more about this trial

Optimizing Exposure Therapy for Anxiety Disorders

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