Effectiveness of the Guided and Traditional Cognitive Behavioral Therapy Protocol in a Patient With Treatment-resistant Panic Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Efficacy criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: The group intervention used the sessions described in traditional form (Behavioral)
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.
Intervention: The group intervention used the sessions described in a self-guided format using an application (Behavioral)
Outcomes
Primary Outcomes
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)
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)
Secondary Outcomes
- Efficacy criteria(Baseline (Week 1) and Post-intervention (Week 8))
- Efficacy criteria(Baseline (Week 1) and Post-intervention (Week 8))
Investigators
Luisa Pelucio Ribeiro Barbosa
Master - Principal Investigator
Universidade Federal do Rio de Janeiro