NCT07391943

Self-Guided CBT Mobile App for Treatment-Resistant Panic Disorder (CBT) Cognitive Behavioral Therapy

Efficacy of a Self-Guided Cognitive Behavioral Therapy Protocol Via Mobile Application in Patients With Treatment-Resistant Panic Disorder: An Open-Label Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Panic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Experimental - 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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Brazil