跳至主要内容
临床试验/NCT07391943
NCT07391943已完成不适用

Efficacy of a Self-Guided Cognitive Behavioral Therapy Protocol Via Mobile Application in Patients With Treatment-Resistant Panic Disorder: An Open-Label Trial

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Beck Anxiety Inventory (BAI) Total Score

研究概览

简要总结

Treatment-resistant panic disorder (TRPD) is characterized by persistent panic symptoms despite adequate pharmacological and/or psychotherapeutic treatment. This open-label study is designed to evaluate a self-guided cognitive behavioral therapy (CBT) protocol delivered via a mobile application for adults with TRPD. The intervention consists of eight weekly sessions covering psychoeducation, panic cycle interruption, cognitive restructuring, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An avatar is incorporated to enhance engagement and simulate therapeutic presence. Participants continue their usual psychiatric follow-up and pharmacological treatment throughout the study. Outcomes are assessed at baseline and after completion of the intervention using validated measures of panic severity, anxiety, depression, mindfulness, coping strategies, quality of life, and affect.

详细描述

Panic disorder (PD) is a prevalent anxiety disorder associated with significant functional impairment. Although pharmacotherapy and cognitive behavioral therapy (CBT) are considered first-line treatments, a substantial proportion of patients continue to experience clinically relevant symptoms, characterizing treatment-resistant panic disorder (TRPD). Digital mental health interventions, particularly self-guided CBT delivered via mobile applications, represent a scalable approach to expanding access to evidence-based care.

This open-label study employs an eight-session self-guided CBT protocol delivered through a mobile application for adults diagnosed with TRPD. The intervention is structured into weekly modules addressing psychoeducation about panic disorder, identification and modification of maladaptive cognitions, interruption of the panic cycle, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An interactive avatar is included to simulate therapeutic presence and support user engagement.

Participants are recruited from a specialized outpatient clinic and are required to maintain ongoing psychiatric follow-up and stable pharmacological treatment during the study period. Study assessments are conducted at baseline and at the end of the eight-week intervention. Outcome measures include validated self-report instruments assessing panic severity, anxiety symptoms, depressive symptoms, mindfulness, coping strategies, quality of life, and positive and negative affect

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60
  • DSM-5 diagnosis of TRPD confirmed by psychiatrist
  • Ongoing psychiatric follow-up
  • Current pharmacological treatment for PD
  • Ability to use smartphone/app

排除标准

  • No PD diagnosis
  • Other primary psychiatric disorder
  • Severe cognitive impairment
  • Inability to use the app

结局指标

主要结局

Beck Anxiety Inventory (BAI) Total Score

时间窗: Baseline (Week 1) and Post-intervention (Week 8)

The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. The BAI is administered to all participants at baseline and at the end of the intervention. Unit of Measure: Points on a scale (0-63)

次要结局

  • Beck Depression Inventory-II (BDI-II) Total Score(Baseline (Week 1) and Post-intervention (Week 8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luisa Pelucio Ribeiro Barbosa

Researcher

Universidade Federal do Rio de Janeiro

研究点 (1)

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