Mobile-assisted Case Management for Panic Disorder
- Conditions
- Panic Disorder
- Registration Number
- NCT05832905
- Lead Sponsor
- En Chu Kong Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- Diagnosis of panic disorder by DSM5
- More than 18 years old
- An essential ability to navigate smartwatch and mobile phone applications
- Current substance abuse
- Cardiopulmonary incapacity
- Incapacity or limited mental capacity
- Acute suicidal ideation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PDSS score through study completion, an average of 1 year Panic severity score
- Secondary Outcome Measures
Name Time Method BAI score through study completion, an average of 1 year The Beck Anxiety Inventory
STAI score through study completion, an average of 1 year The State-Trait Anxiety Inventory
BDI score through study completion, an average of 1 year The Beck Depression Inventory II
Trial Locations
- Locations (1)
En Chu Kong Hospital
🇨🇳Sanxia, New Taipei City, Taiwan
En Chu Kong Hospital🇨🇳Sanxia, New Taipei City, Taiwan