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

NCT07391943 | Completed DMC

• 1 other identifier: UFRJ-2025-002
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Keywords

Panic disorder;; Cognitive behavioral therapy;; Mobile application;; Digital intervention;; Self-guided treatment;; Treatment-resistant panic disorder

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (Week 1) and Post-intervention (Week 8)

Secondary Outcomes (1)

• Beck Depression Inventory-II (BDI-II) Total Score

  Baseline (Week 1) and Post-intervention (Week 8)

Other Outcomes (5)

• Mindful Attention Awareness Scale (MAAS) Total Score

  Baseline (Week 1) and Post-intervention (Week 8)

• WHOQOL-BREF Physical Health Domain Score

  Baseline (Week 1) and Post-intervention (Week 8)

• WHOQOL-BREF Social Relationships Domain Score

  Baseline (Week 1) and Post-intervention (Week 8)

Interventions

Experimental - Self-Guided CBT Mobile App BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients in the panic and respiratory of the Federal University of Rio de Janeiro

You may qualify if:

• 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

You may not qualify if:

• No PD diagnosis
• Other primary psychiatric disorder
• Severe cognitive impairment
• Inability to use the app

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Luisa

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (18)

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  PMID: 39178019 RESULT

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  PMID: 35610590 RESULT

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  PMID: 39924261 RESULT

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MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Luisa Pelucio, Dr

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: February 6, 2026
• Study Start: November 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For free time
• Access Criteria: Just ask for contact information we share.

Locations

BR (1)