Mobile-assisted Case Management for Panic Disorder

Panic Disorder Clinical Trial

— MCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832905
• Other study ID #: EnChuKongH_MCM
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: En Chu Kong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of panic disorder by DSM5

2. More than 18 years old

3. An essential ability to navigate smartwatch and mobile phone applications

Exclusion Criteria:

1. Current substance abuse

2. Cardiopulmonary incapacity

3. Incapacity or limited mental capacity

4. Acute suicidal ideation

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Mobile and Wearable-assisted Case Management
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

Locations

Country	Name	City	State
Taiwan	En Chu Kong Hospital	Sanxia	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
En Chu Kong Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Tsai CH, Chen PC, Liu DS, Kuo YY, Hsieh TT, Chiang DL, Lai F, Wu CT. Panic Attack Prediction Using Wearable Devices and Machine Learning: Development and Cohort Study. JMIR Med Inform. 2022 Feb 15;10(2):e33063. doi: 10.2196/33063. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDSS score	Panic severity score	through study completion, an average of 1 year
Secondary	STAI score	The State-Trait Anxiety Inventory	through study completion, an average of 1 year
Secondary	BDI score	The Beck Depression Inventory II	through study completion, an average of 1 year
Secondary	BAI score	The Beck Anxiety Inventory	through study completion, an average of 1 year