Guided and Traditional Cognitive Behavioral Therapy Protocol for Resistant Panic

November 17, 2025 updated by: Luisa Pelucio Ribeiro Barbosa, Universidade Federal do Rio de Janeiro

Effectiveness of the Guided and Traditional Cognitive Behavioral Therapy Protocol in a Patient With Treatment-resistant Panic Disorder

Self-guided therapy for anxiety disorders has focused on various cognitive-behavioral treatments mediated by technologies such as web applications. This study aims to compare two groups of patients with panic disorder undergoing two clinical psychological treatment models: one traditional cognitive behavioral therapy (CBT), and the other self-guided CBT using a digital application.

An application was developed in which both treatment models follow the same eight-session CBT manual. Patients are evaluated using psychological assessments at the first and eighth sessions.

The study includes 46 patients divided into two groups of 23 participants each. Both groups undergo individual assessments at the beginning and end of the treatment protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As such, an application was developed whereby the two models follow the same treatment manual of eight sessions, with the patients being evaluated using psychological tests at the first and eighth sessions.

Methods: A total of 46 patients were separated into two groups of 23 patients, one in each format, with the patients in both groups being individually evaluated at their first and eighth sessions.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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, Tel. (+55 21) 25216147
        • Universidade Federal do Rio de Janeiro

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

Yes

Description

Inclusion Criteria:

  • Patients undergoing IPUB screening through the panic and respiratory laboratory outpatient clinic.
  • Diagnosis of panic disorder confirmed.
  • Age between 18 and 60 years.
  • Under psychiatric follow-up by a university psychiatrist and taking medication.
  • Provide written informed consent to participate and have data stored.

Exclusion Criteria:

  • Patients without a diagnosis of panic disorder.
  • Age under 18 or over 60 years.
  • Not undergoing psychiatric follow-up.
  • Presence of other psychiatric or medical diagnoses.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of 23 patients undergoing traditional cognitive behavioral therapy
Twenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a traditional cognitive behavioral therapy format, 8-session treatment protocol.
Behavioral: The group intervention used the sessions described in traditional form

Model of the sessions:

  • Session 1 - General information for the Client
  • Session 2 - Breaking the panic cycle
  • Session 3 - Increasing the range of cognitive management skills
  • Session 4 - Improving corporal management skills
  • Session 5 - Strengthening self-efficacy
  • Session 6 - Stimulating life reorientation
  • Session 7 - Promoting existential management
  • Session 8 - Revising and evaluating the treatment
Experimental: Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app
Twenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a self-guided cognitive behavioral therapy format, using the 8-session treatment protocol.
Behavioral: The group intervention used the sessions described in a self-guided format using an application

Model of the sessions:

  • Session 1 - General information for the Client
  • Session 2 - Breaking the panic cycle
  • Session 3 - Increasing the range of cognitive management skills
  • Session 4 - Improving corporal management skills
  • Session 5 - Strengthening self-efficacy
  • Session 6 - Stimulating life reorientation
  • Session 7 - Promoting existential management
  • Session 8 - Revising and evaluating the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy criteria
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

Primary Outcome Measure 1 Title: Beck Anxiety Inventory (BAI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BAI is a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Total scores range from 0 to 63; higher scores indicate greater anxiety. Administered to all participants in both groups. Results will be reported separately for each time point.

Unit of Measure: Points on a scale (0-63) Primary Outcome Measure 2 Title: Beck Depression Inventory (BDI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BDI is a 21-item self-report inventory assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater severity of depression. Applied to all participants in both groups, with separate reporting for each assessment.

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
Efficacy criteria
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

Outcome Measure 3 Title: Mindful Attention Awareness Scale (MAAS) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The MAAS is a 15-item scale measuring mindfulness in daily life. Scores range from 15 to 90; higher scores reflect greater mindfulness. Administered to all participants. Scores will be reported separately at each time point.

Unit of Measure: Points on a scale (15-90) Outcome Measure 4 Title: Brief Resilient Coping Scale (BRCS) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BRCS is a 4-item scale assessing the tendency to cope with stress in a resilient manner. Scores range from 4 to 20; higher scores indicate more adaptive coping. Administered to both groups. Each time point reported separately.

Unit of Measure: Points on a scale (4-20)
Baseline (Week 1) and Post-intervention (Week 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy criteria
Time Frame: Baseline (Week 1) and Post-intervention (Week 8)

Outcome Measure 5 Title: WHOQOL-BREF domain scores - Physical, Social, Environmental Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The WHOQOL-BREF assesses quality of life. This outcome includes scores from the Physical Health, Social Relationships, and Environment domains. Each domain score ranges from 4 to 20; higher scores represent better quality of life.

Unit of Measure: Points on a scale (4-20) Outcome Measure 6 Title: Panic and Agoraphobia Scale (PAS) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The PAS is a clinician-administered scale with 13 items assessing the severity of panic and agoraphobia symptoms. Scores range from 0 to 52; higher scores indicate more severe symptoms. Applied to all participants.

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, Master, 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)

April 5, 2023

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

May 2, 2025

Study Registration Dates

First Submitted

May 22, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRJ-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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