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

January 29, 2026 updated by: Luisa Pelucio Ribeiro Barbosa, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil
        • Luisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Anxiety Inventory (BAI) Total Score
Time Frame: 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)
Baseline (Week 1) and Post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II (BDI-II) Total Score
Time Frame: 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)
Baseline (Week 1) and Post-intervention (Week 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindful Attention Awareness Scale (MAAS) Total Score
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

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)
Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Physical Health Domain Score
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

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)
Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Social Relationships Domain Score
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

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)
Baseline (Week 1) and Post-intervention (Week 8)
WHOQOL-BREF Environment Domain Score
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

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)
Baseline (Week 1) and Post-intervention (Week 8)
Panic and Agoraphobia Scale (PAS) Total Score
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Luisa Pelucio, Dr, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

August 16, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRJ-2025-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

For free time

IPD Sharing Access Criteria

Just ask for contact information we share.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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