Optimizing Exposure Therapy for Anxiety Disorders

NCT ID: NCT04048824

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-14
• Study Completion Date: 2025-01-01

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.

Conditions

Social Anxiety Disorder; Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inhibitory Learning-Based Exposure

Participants will receive exposure therapy aimed at increasing inhibitory learning.

Group Type: EXPERIMENTAL

Inhibitory Learning-Based Exposure

Intervention Type: BEHAVIORAL

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.

Habituation-Based Exposure

Participants will receive exposure therapy aimed at reducing fear responding.

Group Type: ACTIVE_COMPARATOR

Habituation-Based Exposure

Intervention Type: BEHAVIORAL

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.

Interventions

Inhibitory Learning-Based Exposure

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

Habituation-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Michelle Craske

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle G Craske, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Optimizing Exposure

Identifier Type: -

Identifier Source: org_study_id