Guided and Traditional Cognitive Behavioral Therapy Protocol for Resistant Panic

NCT ID: NCT07247955

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2025-05-02

Brief Summary

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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

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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.

Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

The group intervention used the sessions described in traditional form

Intervention Type 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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Luisa Pelucio Ribeiro Barbosa

Master - Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luisa Pelucio, Master

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Universidade Federal do Rio de JAneiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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Linardon J. Can Acceptance, Mindfulness, and Self-Compassion Be Learned by Smartphone Apps? A Systematic and Meta-Analytic Review of Randomized Controlled Trials. Behav Ther. 2020 Jul;51(4):646-658. doi: 10.1016/j.beth.2019.10.002. Epub 2019 Nov 26.

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Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.

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Wu J, Ma Y, Zuo Y, Zheng K, Zhou Z, Qin Y, Ren Z. Effects of Mindfulness Exercise Guided by a Smartphone App on Negative Emotions and Stress in Non-Clinical Populations: A Systematic Review and Meta-Analysis. Front Public Health. 2022 Jan 25;9:773296. doi: 10.3389/fpubh.2021.773296. eCollection 2021.

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PMID: 35155341 (View on PubMed)

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Hansen WB, Scheier LM. Specialized Smartphone Intervention Apps: Review of 2014 to 2018 NIH Funded Grants. JMIR Mhealth Uhealth. 2019 Jul 29;7(7):e14655. doi: 10.2196/14655.

Reference Type RESULT
PMID: 31359866 (View on PubMed)

Hwang WJ, Ha JS, Kim MJ. Research Trends on Mobile Mental Health Application for General Population: A Scoping Review. Int J Environ Res Public Health. 2021 Mar 2;18(5):2459. doi: 10.3390/ijerph18052459.

Reference Type RESULT
PMID: 33801537 (View on PubMed)

Firth J, Torous J, Carney R, Newby J, Cosco TD, Christensen H, Sarris J. Digital Technologies in the Treatment of Anxiety: Recent Innovations and Future Directions. Curr Psychiatry Rep. 2018 May 19;20(6):44. doi: 10.1007/s11920-018-0910-2.

Reference Type RESULT
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Wright JH, Mishkind M, Eells TD, Chan SR. Computer-Assisted Cognitive-Behavior Therapy and Mobile Apps for Depression and Anxiety. Curr Psychiatry Rep. 2019 Jun 27;21(7):62. doi: 10.1007/s11920-019-1031-2.

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Khademian F, Aslani A, Bastani P. The effects of mobile apps on stress, anxiety, and depression: overview of systematic reviews. Int J Technol Assess Health Care. 2020 Dec 14;37:e4. doi: 10.1017/S0266462320002093.

Reference Type RESULT
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Ito LM, Noshirvani H, Basoglu M, Marks IM. Does exposure to internal cues enhance exposure to external cues in agoraphobia with panic? A pilot controlled study of self-exposure. Psychother Psychosom. 1996;65(1):24-28. doi: 10.1159/000289027.

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Ito LM, de Araujo LA, Tess VL, de Barros-Neto TP, Asbahr FR, Marks I. Self-exposure therapy for panic disorder with agoraphobia: randomised controlled study of external v. interoceptive self-exposure. Br J Psychiatry. 2001 Apr;178:331-6. doi: 10.1192/bjp.178.4.331.

Reference Type RESULT
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Clark DM. A cognitive approach to panic. Behav Res Ther. 1986;24(4):461-70. doi: 10.1016/0005-7967(86)90011-2. No abstract available.

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Other Identifiers

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UFRJ-2025-001

Identifier Type: -

Identifier Source: org_study_id

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