Guided and Traditional Cognitive Behavioral Therapy Protocol for Resistant Panic

NCT07247955 | Completed DMC

• 1 other identifier: UFRJ-2025-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Panic Disorder

Keywords

Panic disorder; Cognitive behavioral therapy; Application

Outcome Measures

Primary Outcomes (1)

• Efficacy criteria

  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 Outcomes (1)

• Efficacy criteria

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

Other Outcomes (1)

• Efficacy criteria

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

Study Arms (2)

Group of 23 patients undergoing traditional cognitive behavioral therapy

EXPERIMENTAL

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

Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app

EXPERIMENTAL

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

Interventions

The group intervention used the sessions described in traditional form BEHAVIORAL

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

Group of 23 patients undergoing traditional cognitive behavioral therapy

The group intervention used the sessions described in a self-guided format using an application BEHAVIORAL

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

Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Universidade Federal do Rio de JAneiro

Rio de Janeiro, Rio de Janeiro, Tel. (+55 21) 25216147, Brazil

Location

Related Publications (17)

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MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Luisa Pelucio, Master

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master - Principal Investigator

Model Details: As a pilot study comparing two groups of patients with PD in different forms of care, the data from 23 patients with panic disorder undergoing traditional CBT and 23 patients with panic disorder doing self-guided therapy through an application were collected. The groups were randomized, they had no comorbidities, all patients were undergoing psychiatric follow-up.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: November 25, 2025
• Study Start: April 5, 2023
• Primary Completion: October 15, 2024
• Study Completion: May 2, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)