Clinical trial NCT04048824: Optimizing Exposure Therapy for Anxiety Disorders
Official title: Inhibitory Learning vs. Habituation: Models of Exposure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Panic Disorder
Keywords: inhibitory learning
exposure
anxiety
habituation
social anxiety
panic
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in clinician-rated severity of social anxiety or panic disorder
timeFrame: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
measure: Change in self-reported symptom severity of social anxiety or panic disorder
timeFrame: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
Secondary outcomes:
measure: Change in fear extinction generalization as measured by expectancy of unconditional stimuli during conditional stimuli presentation.
timeFrame: Pre-treatment to post-treatment (9 weeks)
measure: Change in fear extinction generalization as measured by skin conductance.
timeFrame: Pre-treatment to post-treatment (9 weeks)
measure: Change in fear extinction generalization as measured by heart rate.
timeFrame: Pre-treatment to post-treatment (10 weeks)
measure: Implicit Fear Association Test
timeFrame: Pre-treatment to post-treatment (10 weeks)
measure: Behavioral Avoidance Test (BAT)
timeFrame: Pre-treatment to post-treatment (10 weeks)
measure: Probability and Cost Questionnaire
timeFrame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
measure: Positive and Negative Affect Schedule (PANAS 20 item)
timeFrame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
measure: Panic Disorder Severity Scale-Self Report (PDSS-SR)
timeFrame: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
measure: Sheehan Disability Scale (SDS)
timeFrame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
measure: Mini-SPIN
timeFrame: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michelle G Craske, PhD
role: PRINCIPAL_INVESTIGATOR
References: