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Guided and Traditional Cognitive Behavioral Therapy Protocol for Resistant Panic

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07247955
Enrollment
46
Registered
2025-11-25
Start date
2023-04-05
Completion date
2025-05-02
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

Keywords

Panic disorder, Cognitive behavioral therapy, Application

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.

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.

Interventions

BEHAVIORALThe 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

BEHAVIORALThe 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

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy criteriaBaseline (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)

Secondary

MeasureTime frameDescription
Efficacy criteriaBaseline (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)

Other

MeasureTime frameDescription
Efficacy criteriaBaseline (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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026