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Completed

NCT Number: NCT07391943

Self-Guided CBT Mobile App for Treatment-Resistant Panic Disorder (CBT) Cognitive Behavioral Therapy

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luisa

Rio de Janeiro, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Experimental - Self-Guided CBT Mobile App

Behavioral

Eight-session manualized CBT protocol delivered via mobile app, including psychoeducation, cognitive restructuring, relaxation, behavioral activation, assertiveness, and life reorganization, with avatar interface to enhance engagement.

Primary outcomes

  1. Beck Anxiety Inventory (BAI) Total Score

    Time frame: 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)

Secondary outcomes

  1. Beck Depression Inventory-II (BDI-II) Total Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater depression severity. The BDI-II is administered to all participants at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (0-63)

Other outcomes

  1. Mindful Attention Awareness Scale (MAAS) Total Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report questionnaire that assesses dispositional mindfulness in daily life. Total scores range from 15 to 90, with higher scores indicating greater mindfulness. The MAAS is administered to all participants at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (15-90)

  2. WHOQOL-BREF Physical Health Domain Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The World Health Organization Quality of Life-BREF (WHOQOL-BREF) Physical Health domain assesses physical aspects of quality of life, including energy, mobility, and daily activities. Domain scores range from 4 to 20, with higher scores indicating better perceived physical quality of life. The domain score is assessed at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (4-20)

  3. WHOQOL-BREF Social Relationships Domain Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The WHOQOL-BREF Social Relationships domain evaluates interpersonal relationships, social support, and personal relationships. Domain scores range from 4 to 20, with higher scores indicating better social quality of life. The domain score is assessed at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (4-20)

  4. WHOQOL-BREF Environment Domain Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The WHOQOL-BREF Environment domain assesses perceptions of safety, home environment, financial resources, access to health care, and opportunities for leisure. Domain scores range from 4 to 20, with higher scores indicating better environmental quality of life. The domain score is assessed at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (4-20)

  5. Panic and Agoraphobia Scale (PAS) Total Score

    Time frame: Baseline (Week 1) and Post-intervention (Week 8)

    The Panic and Agoraphobia Scale (PAS) is a clinician-administered instrument consisting of 13 items that assess the severity of panic and agoraphobia symptoms. Total scores range from 0 to 52, with higher scores indicating greater symptom severity. The PAS is administered at baseline and at the end of the intervention.

    Unit of Measure: Points on a scale (0-52)

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

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

Acronym: (CBT)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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