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.
None
Age between 18 and 70 years.
Seeking treatment for anxiety-related difficulties.
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.
Parallel
Expectancy Focused Exposure
BehavioralExpectancy Focused Exposure is an exposure-based psychological treatment grounded in the inhibitory learning model of exposure therapy (Craske, 2022). The intervention emphasizes the identification and testing of explicit threat expectations associated with feared stimuli or situations. Exposure exercises are designed to maximize expectancy violation by confronting situations that strongly predict feared outcomes and by systematically testing whether these outcomes occur. The goal of the intervention is to strengthen inhibitory learning by disconfirming threat predictions rather than by reducing anxiety during exposure. Clinically, this approach guides how exposure exercises are designed and implemented. Therapists construct a comprehensive associative map of the feared situation in order to plan exposures that maximally challenge the patient's threat expectations. This associative map includes the feared element (conditioned stimulus; CS), the expected consequence (unconditioned stimu
Anxiety Focused Exposure
BehavioralAnxiety Focused Exposure is a traditional exposure-based cognitive behavioral therapy approach in which exposure exercises are organized according to a graduated hierarchy of feared situations or stimuli. The primary goal of the intervention is to reduce anxiety responses through repeated confrontation with anxiety-provoking stimuli. Exposure sessions focus on gradual increases in exposure intensity while monitoring anxiety levels across repeated exposures. In this approach, the therapist and the participant collaboratively construct an exposure hierarchy that organizes feared situations from least to most anxiety-provoking. This hierarchy allows participants to approach feared situations progressively, beginning with stimuli that evoke lower levels of anxiety and gradually advancing toward more challenging situations. Exposure exercises are conducted following this hierarchical structure, with the aim of promoting reductions in anxiety as individuals repeatedly confront feared situati
Change in standardized disorder-specific anxiety symptom severity
Severity of the principal anxiety disorder will be assessed using one disorder-specific measure according to each participant's primary diagnosis: the Liebowitz Social Anxiety Scale for social anxiety disorder, the Severity Measure for Specific Phobia-Adult for specific phobia, the Generalized Anxiety Disorder 7-item Scale for generalized anxiety disorder, or the Panic and Agoraphobia Scale for panic disorder with or without agoraphobia. Each scale yields a total symptom severity score, with higher scores indicating greater anxiety severity. Score ranges are: Liebowitz Social Anxiety Scale, 0-72; Severity Measure for Specific Phobia-Adult, 0-40; Generalized Anxiety Disorder 7-item Scale, 0-21; and Panic and Agoraphobia Scale, 0-52. Raw total scores will be transformed into standardized z-scores before analysis. The reported outcome will be a single aggregated standardized z-score representing disorder-specific anxiety severity. Higher z-scores indicate greater symptom severity.
Change in general anxiety symptoms
General anxiety symptoms will be assessed using the Beck Anxiety Inventory. The Beck Anxiety Inventory is a 21-item self-report measure of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety symptom severity.
Change in general psychological distress
General psychological distress will be assessed using the Clinical Outcomes in Routine Evaluation-Outcome Measure. The Clinical Outcomes in Routine Evaluation-Outcome Measure is a 34-item self-report measure of psychological distress and functioning. The total raw score ranges from 0 to 136, with higher scores indicating greater psychological distress and poorer functioning.
Clinically significant change in standardized disorder-specific anxiety symptom severity
Clinically significant change will be evaluated using standardized disorder-specific anxiety symptom severity scores. Disorder-specific symptom scores will be transformed into z-scores prior to analysis to allow comparison across participants with different principal anxiety disorders. Clinically significant change will be estimated using reliable change indices when available. When reliable change indices based on Chilean norms are unavailable, alternative estimates will be used, and the Standardized Individual Difference will be calculated as an additional indicator of individual change. Higher standardized scores indicate greater disorder-specific anxiety symptom severity, whereas lower scores indicate lower symptom severity. The standardized z-score does not have a fixed minimum or maximum value.
Recurrence of anxiety symptoms during follow-up
Recurrence of anxiety symptoms will be evaluated using standardized disorder-specific anxiety symptom severity scores during follow-up. Disorder-specific symptom scores will be transformed into z-scores prior to analysis to allow comparison across participants with different principal anxiety disorders. Recurrence will be defined as a clinically meaningful increase in standardized disorder-specific anxiety symptom severity after post-treatment improvement, based on reliable change criteria when available or alternative individual-level change indicators. Higher standardized scores indicate greater disorder-specific anxiety symptom severity, whereas lower scores indicate lower symptom severity. The standardized z-score does not have a fixed minimum or maximum value.
Change in quality of life
Quality of life will be assessed using the Quality of Life Scale. The Quality of Life Scale is a self-report measure of perceived quality of life. Total scores range from 16 to 112, with higher scores indicating better quality of life.
Change in state anxiety
State anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. This subscale assesses current anxiety symptoms. Scores range from 0 to 60, with higher scores indicating greater state anxiety.
Change in trait anxiety
Trait anxiety will be assessed using the Trait Anxiety subscale of the State-Trait Anxiety Inventory. This subscale assesses dispositional anxiety. Scores range from 0 to 60, with higher scores indicating greater trait anxiety.
Change in depressive symptoms
Depressive symptoms will be assessed using the Beck Depression Inventory-I. The Beck Depression Inventory-I is a 21-item self-report measure of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.
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University of Chile
Lead sponsor
Universidad de los Andes, Chile
Collaborator
