An observational study in Panic Disorder, sponsored by Universidade Federal do Rio de Janeiro. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Universidade Federal do Rio de Janeiro · Observational
Treatment-resistant panic disorder (TRPD) is characterized by persistent panic symptoms despite adequate pharmacological and/or psychotherapeutic treatment. This open-label study is designed to evaluate a self-guided cognitive behavioral therapy (CBT) protocol delivered via a mobile application for adults with TRPD. The intervention consists of eight weekly sessions covering psychoeducation, panic cycle interruption, cognitive restructuring, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An avatar is incorporated to enhance engagement and simulate therapeutic presence. Participants continue their usual psychiatric follow-up and pharmacological treatment throughout the study. Outcomes are assessed at baseline and after completion of the intervention using validated measures of panic severity, anxiety, depression, mindfulness, coping strategies, quality of life, and affect.
Panic disorder (PD) is a prevalent anxiety disorder associated with significant functional impairment. Although pharmacotherapy and cognitive behavioral therapy (CBT) are considered first-line treatments, a substantial proportion of patients continue to experience clinically relevant symptoms, characterizing treatment-resistant panic disorder (TRPD). Digital mental health interventions, particularly self-guided CBT delivered via mobile applications, represent a scalable approach to expanding access to evidence-based care.
This open-label study employs an eight-session self-guided CBT protocol delivered through a mobile application for adults diagnosed with TRPD. The intervention is structured into weekly modules addressing psychoeducation about panic disorder, identification and modification of maladaptive cognitions, interruption of the panic cycle, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An interactive avatar is included to simulate therapeutic presence and support user engagement.
Participants are recruited from a specialized outpatient clinic and are required to maintain ongoing psychiatric follow-up and stable pharmacological treatment during the study period. Study assessments are conducted at baseline and at the end of the eight-week intervention. Outcome measures include validated self-report instruments assessing panic severity, anxiety symptoms, depressive symptoms, mindfulness, coping strategies, quality of life, and positive and negative affect
250 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.
This study's enrollment of 45 is below the median of 200 across 50 observational studies indexed under Panic Disorder.
Browse Panic Disorder studies →Universidade Federal do Rio de Janeiro is the lead sponsor of 120 studies on the registry; 11 are open to participants now.
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Patients in the panic and respiratory of the Federal University of Rio de Janeiro
Exclusion Criteria:
Eight-session manualized CBT protocol delivered via mobile app, including psychoeducation, cognitive restructuring, relaxation, behavioral activation, assertiveness, and life reorganization, with avatar interface to enhance engagement.
Beck Anxiety Inventory (BAI) Total Score
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. The BAI is administered to all participants at baseline and at the end of the intervention. Unit of Measure: Points on a scale (0-63)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Beck Depression Inventory-II (BDI-II) Total Score
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater depression severity. The BDI-II is administered to all participants at baseline and at the end of the intervention. Unit of Measure: Points on a scale (0-63)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Mindful Attention Awareness Scale (MAAS) Total Score
The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report questionnaire that assesses dispositional mindfulness in daily life. Total scores range from 15 to 90, with higher scores indicating greater mindfulness. The MAAS is administered to all participants at baseline and at the end of the intervention. Unit of Measure: Points on a scale (15-90)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Physical Health Domain Score
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) Physical Health domain assesses physical aspects of quality of life, including energy, mobility, and daily activities. Domain scores range from 4 to 20, with higher scores indicating better perceived physical quality of life. The domain score is assessed at baseline and at the end of the intervention. Unit of Measure: Points on a scale (4-20)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Social Relationships Domain Score
The WHOQOL-BREF Social Relationships domain evaluates interpersonal relationships, social support, and personal relationships. Domain scores range from 4 to 20, with higher scores indicating better social quality of life. The domain score is assessed at baseline and at the end of the intervention. Unit of Measure: Points on a scale (4-20)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Environment Domain Score
The WHOQOL-BREF Environment domain assesses perceptions of safety, home environment, financial resources, access to health care, and opportunities for leisure. Domain scores range from 4 to 20, with higher scores indicating better environmental quality of life. The domain score is assessed at baseline and at the end of the intervention. Unit of Measure: Points on a scale (4-20)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Panic and Agoraphobia Scale (PAS) Total Score
The Panic and Agoraphobia Scale (PAS) is a clinician-administered instrument consisting of 13 items that assess the severity of panic and agoraphobia symptoms. Total scores range from 0 to 52, with higher scores indicating greater symptom severity. The PAS is administered at baseline and at the end of the intervention. Unit of Measure: Points on a scale (0-52)
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Plan to share: Yes — Study Protocol
Supporting information: Study protocol
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio de Janeiro