Optimizing Exposure Therapy for Anxiety Disorders (OptEx)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    120
  • sponsor
    University of California, Los Angeles
Updated on 12 April 2022
anxiety
panic disorder
social phobia
exposure therapy
anxiety disorder
psychotherapeutic
psychotropic drug

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.

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.

Details
Condition Social Anxiety Disorder, Panic Disorder
Treatment Inhibitory Learning-Based Exposure, Habituation-Based Exposure
Clinical Study IdentifierNCT04048824
SponsorUniversity of California, Los Angeles
Last Modified on12 April 2022

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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