This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders. Specifically, it examines whether Expectancy Focused Exposure (EFE), based on the inhibitory learning model, is more effective than Anxiety Focused Exposure (AFE) in reducing anxiety symptoms and preventing the return of fear over time. The study includes adult…
This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders. Specifically, it examines whether Expectancy Focused Exposure (EFE), based on the inhibitory learning model, is more effective than Anxiety Focused Exposure (AFE) in reducing anxiety symptoms and preventing the return of fear over time. The study includes adults aged 18 years and older diagnosed with an anxiety disorder, including social anxiety disorder, specific phobia, generalized anxiety disorder, and panic disorder with or without agoraphobia. Anxiety disorders are highly prevalent and can significantly interfere with daily functioning, work performance, and interpersonal relationships. Exposure therapy is a central component of cognitive behavioral treatment for anxiety disorders. Traditional exposure approaches often focus on reducing anxiety during exposure sessions, but many individuals experience a return of fear after treatment. New theoretical models suggest that exposure may be more effective when designed to violate threat expectations and strengthen inhibitory learning. Participants will be recruited in sequential cohorts and randomly assigned to immediate treatment or a brief waitlist before treatment begins. Those assigned to the waitlist will start treatment at the next study step. When treatment begins, participants will receive either EFE or AFE. Both treatments consist of approximately 10 weekly individual psychotherapy sessions delivered by trained therapists. Participants will complete clinical assessments before treatment, during treatment, immediately after treatment, and at 6, 12, and 18 months after treatment completion. In AFE, exposure exercises are organized along an anxiety hierarchy and focus on reducing anxiety responses through repeated confrontation with feared stimuli. In EFE, exposure focuses on identifying and testing threat expectations, and exercises are designed to maximize expectancy violation and strengthen inhibitory learning. Potential risks include temporary emotional discomfort during exposure exercises. All sessions will be conducted by trained clinicians who monitor participant safety throughout the study. The results may help improve exposure-based treatments for anxiety disorders by identifying strategies that enhance long-term outcomes and reduce relapse.
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Eligibility Criteria
Population Description The study sample will consist of adult participants from the general population seeking psychological treatment for anxiety-related problems. Participants will be recruited through multiple sources, including university mental health services, student wellbeing units, communit…
Population Description The study sample will consist of adult participants from the general population seeking psychological treatment for anxiety-related problems. Participants will be recruited through multiple sources, including university mental health services, student wellbeing units, community mental health centers, social media advertisements, and other public outreach channels. Recruitment will be intentionally broad to maximize accessibility and ecological validity.
Screening and Selection Procedures Eligibility will be determined through a multi-stage screening process. Initial Screening: DSM-5 Cross-Cutting Measures, Levels 1 and 2 Participants responding to recruitment will first complete the DSM-5 Level 1 Cross-Cutting Symptom Measure (APA, 2013; Spanish version APA, 2014). This self-report instrument includes 23 items assessing 13 domains of psychopathology over the past 14 days using a 5-point Likert scale. It has shown good reliability and clinical utility in prior studies (APA, 2014; Bravo et al., 2018).
Participants who meet threshold criteria for anxiety-related symptoms on the Level 1 measure will then complete the corresponding DSM-5 Level 2 anxiety measures to further characterize symptom severity.
Disorder-Specific Symptom Assessment, Level 3 Participants who meet screening criteria on Levels 1 and 2 will complete disorder-specific symptom scales according to the anxiety disorder suspected or reported, including measures for social anxiety disorder, specific phobia, generalized anxiety disorder, and panic disorder with or without agoraphobia.
Diagnostic Assessment Participants who remain eligible after the screening and disorder-specific symptom assessment will undergo a structured clinical interview using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). The ADIS-5 will be used to establish the principal anxiety disorder diagnosis and to assess exclusion criteria, including psychotic disorder, bipolar disorder, high suicide risk, and severe or uncontrolled substance use disorder.
Inclusion Criteria:
Participants must meet all of the following criteria:
* Age between 18 and 70 years.
* Seeking treatment for anxiety-related difficulties.
* Meet DSM-5 diagnostic criteria for a principal anxiety disorder, including:
social anxiety disorder, specific phobia, generalized anxiety disorder, panic disorder with or without agoraphobia.
* Diagnosis will be established using the ADIS-5 structured clinical interview.
* For participants with generalized anxiety disorder, treatment will focus on the principal anxiety problem identified during assessment.
* Present clinically significant anxiety symptoms associated with the principal diagnosis.
* If currently taking anxiolytic medication, the dosage must have remained stable for at least three months before the start of treatment and should be maintained during the treatment phase whenever possible.
* Willingness and ability to participate in weekly psychotherapy sessions and complete all study assessments.
* Provide informed consent.
Exclusion Criteria:
Participants will be excluded if any of the following conditions are present:
* Current psychotic disorder.
* Current manic or hypomanic episode, consistent with bipolar disorder.
* High suicide risk requiring immediate clinical intervention.
* Severe or uncontrolled substance use disorder.
* Concurrent participation in psychological treatment specifically targeting the anxiety disorder during the study period.
* Medical conditions that contraindicate exposure procedures (e.g., severe cardiovascular conditions).
* Cognitive impairment or insufficient language proficiency that would interfere with participation in psychotherapy or completion of assessments.
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