Panic Disorder
Conditions
Keywords
Panic disorder;, Cognitive behavioral therapy;, Mobile application;, Digital intervention;, Self-guided treatment;, Treatment-resistant panic disorder
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALExperimental - Self-Guided CBT Mobile App
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.
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 * DSM-5 diagnosis of TRPD confirmed by psychiatrist * Ongoing psychiatric follow-up * Current pharmacological treatment for PD * Ability to use smartphone/app
Exclusion criteria
* No PD diagnosis * Other primary psychiatric disorder * Severe cognitive impairment * Inability to use the app
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) Total Score | Baseline (Week 1) and Post-intervention (Week 8) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) Total Score | Baseline (Week 1) and Post-intervention (Week 8) | 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) |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORLuisa Pelucio, Dr
Universidade Federal do Rio de Janeiro
Outcome results
None listed