Social Anxiety DisorderOptExNCT04048824
Optimizing Exposure Therapy for Anxiety Disorders
A study testing Inhibitory Learning-Based Exposure and Habituation-Based Exposure in people with Social Anxiety Disorder and Panic Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Inhibitory Learning-Based Exposure and Habituation-Based Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2015to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Inhibitory Learning vs. Habituation: Models of Exposure Therapy
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.
Read the 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
- Being tested
- Inhibitory Learning-Based Exposure, Habituation-Based Exposure
- Keywords
- inhibitory learning, exposure, anxiety, habituation, social anxiety, panic
- Medical subject headings
- Phobia, Social, Panic Disorder, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibitory Learning-Based ExposureBehavioural
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 ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhibitory Learning-Based Exposure | Experimental | Participants will receive exposure therapy aimed at increasing inhibitory learning. Receives: Behavioral: Inhibitory Learning-Based Exposure |
| Habituation-Based Exposure | Active comparator | Participants will receive exposure therapy aimed at reducing fear responding. Receives: Behavioral: Habituation-Based Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
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).
Measured: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
Secondary outcomes (11)
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.
Measured: Pre-treatment to post-treatment (9 weeks)
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)
Measured: Pre-treatment to post-treatment (9 weeks)
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)
Measured: Pre-treatment to post-treatment (10 weeks)
Implicit Fear Association Test
Change in implicit associations for fear-relevant word stimuli
Measured: Pre-treatment to post-treatment (10 weeks)
Behavioral Avoidance Test (BAT)
Change in duration and subjective fear of public speaking in situ
Measured: Pre-treatment to post-treatment (10 weeks)
Probability and Cost Questionnaire
Change in perceived likelihood and perceived consequence of fear-relevant outcomes
Measured: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Anxiety Sensitivity Index (ASI-3)
Change in appraisal of harmfulness of symptoms
Measured: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Positive and Negative Affect Schedule (PANAS 20 item)
Change in affect
Measured: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Change in panic disorder symptoms
Measured: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Sheehan Disability Scale (SDS)
Change in functioning related to mental health
Measured: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Mini-SPIN
Change in social anxiety symptoms. Scores on the Mini-SPIN range from 0 to 12 with higher scores indicating higher social anxiety severity.
Measured: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start14 Aug 2015
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
- Investigators
- Michelle G Craske, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048824
- Sponsor's protocol ID
- Optimizing Exposure
- Acronym
- OptEx
- Status last verified
- Apr 2025
- First submitted
- 26 Nov 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Learning vs. Habituation: Models of Exposure Therapy
- ClinicalTrials.gov ID
- NCT04048824
- Acronym / sponsor ID
- OptEx / Optimizing Exposure
- Conditions
- Social Anxiety Disorder, Panic Disorder
- Keywords
- inhibitory learning, exposure, anxiety, habituation, social anxiety, panic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitory Learning-Based Exposure | Experimental | Behavioral: Inhibitory Learning-Based ExposureParticipants will receive exposure therapy aimed at increasing inhibitory learning. |
| Habituation-Based Exposure | Active comparator | Behavioral: Habituation-Based ExposureParticipants will receive exposure therapy aimed at reducing fear responding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhibitory Learning-Based Exposure9 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. | Behavioural | Inhibitory Learning-Based Exposure |
| Habituation-Based Exposure9 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. | Behavioural | Habituation-Based Exposure |
Primary outcome
Change in clinician-rated severity of social anxiety or panic disorder
Time frame: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
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
Time frame: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)
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).
11 secondary outcomes
Change in fear extinction generalization as measured by expectancy of unconditional stimuli during conditional stimuli presentation.
Time frame: Pre-treatment to post-treatment (9 weeks)
Change in fear extinction generalization as measured by skin conductance.
Time frame: Pre-treatment to post-treatment (9 weeks)
Change in fear extinction generalization as measured by heart rate.
Time frame: Pre-treatment to post-treatment (10 weeks)
Implicit Fear Association Test
Time frame: Pre-treatment to post-treatment (10 weeks)
Behavioral Avoidance Test (BAT)
Time frame: Pre-treatment to post-treatment (10 weeks)
Probability and Cost Questionnaire
Time frame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Anxiety Sensitivity Index (ASI-3)
Time frame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Positive and Negative Affect Schedule (PANAS 20 item)
Time frame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Time frame: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Sheehan Disability Scale (SDS)
Time frame: Pre-treatment to post-treatment (10 weeks) and follow-up (24 weeks)
Mini-SPIN
Time frame: Weekly throughout the duration of treatment (10 weeks) and once at follow-up (24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle G Craske, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibitory Learning-Based Exposure and Habituation-Based Exposure in people with Social Anxiety Disorder and Panic Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinician-rated severity of social anxiety or panic disorder (time frame: Pre-treatment to post-treatment (10 weeks), to follow-up (24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.