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Completed

NCT Number: NCT05832905

Mobile-assisted Case Management for Panic Disorder

A panic attack (PA) is an intense form of anxiety accompanied by multiple somatic presentations, leading to frequent emergency department visits and impairing quality of life. A prediction model for PAs could help clinicians and patients monitor, control, and do early intervention for recurrent panic attacks, enabling more personalized treatment for panic disorder. This study aimed to provide a seven-day PA prediction model and determine the relationship between a future PA and various features, including physiological factors, anxiety and depressive factors, and air quality index. We will enroll 200 participants (150 participants join case management with wearables study, 50 participants join TAU group) with PD (DMS-5 and MINI interview). Participants used smartwatches (Garmin vivosmart 4) and mobile applications to collect their sleep, heart rate, activity level, anxiety, and depression scores (BDI, BAI, STAI-S, STAI-T, and PDSS-SR) in their real-life for a duration of one year. We also included air quality indexes from open data. To analyze these data, our team used six machine learning methods: random forests, decision trees, LDA, AdaBoost, XGBoost, and regularized greedy forests, or other deep learning methods.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

En Chu Kong Hospital

Sanxia District, New Taipei City, 237, Taiwan

About this study

Participants enrollment Through primary psychiatrists' invitations, we will recruit 150 En Chu Kong Hospital psychiatric clinic PD participants and 50 patients from Mackay Memorial Hospital.

Inclusion criteria

The inclusion criteria were 1) a primary diagnosis of PD by DSM-5, 2) more than 20 years old, and 3) an essential ability to navigate smartwatches and mobile phone applications. If participants did not fulfill criteria 3), we will invite them as the control group (i.e. TAU)

Exclusion criteria

The exclusion criteria were 1) current substance abuse, 2) cardiopulmonary incapacity, 3) incapacity or limited mental capacity, and 4) acute suicidal ideation. This study required sufficient mental capacity on the part of participants to cooperate by wearing smartwatches continuously, properly maintaining the smartwatches, and completing regular, valid online questionnaires. Limited mental capacity implies that the participants have difficulties understanding, remembering, or using the information to make or communicate a decision. Our team evaluated participants' mental capacity during the diagnostic interview (DI), Mini International Neuropsychiatric Interview (MINI), and the informed consent process by certified psychiatrists and nurse practitioners. The information on acute suicidal ideation was from diagnostic interviews and questions from MINI part A and pre-assessment BDI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of panic disorder by DSM5
  • More than 18 years old
  • An essential ability to navigate smartwatch and mobile phone applications

Exclusion criteria

  • Current substance abuse
  • Cardiopulmonary incapacity
  • Incapacity or limited mental capacity
  • Acute suicidal ideation

Treatment and study plan

Mobile and Wearable-assisted Case Management

Behavioral

The MCM group received case management and Mobile-and wearable recording. The actual intervention for Panic disorder, including pharmacotherapy or psychological treatment is the same as in MCM and TAU group

Primary outcomes

  1. PDSS score

    Time frame: through study completion, an average of 1 year

    Panic severity score

Secondary outcomes

  1. STAI score

    Time frame: through study completion, an average of 1 year

    The State-Trait Anxiety Inventory

  2. BDI score

    Time frame: through study completion, an average of 1 year

    The Beck Depression Inventory II

  3. BAI score

    Time frame: through study completion, an average of 1 year

    The Beck Anxiety Inventory

Sponsors and collaborators

Lead sponsor

En Chu Kong Hospital

Other

Collaborators

  • National Taiwan University

Registry information

Official study title

Mobile and Wearable-assisted Case Management for Panic Disorder: An Observational Cohort Study Using Machine Learning and Explainable AI

Acronym: MCM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Mar 1, 2024

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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