Mobile-assisted Case Management for Panic Disorder

NCT05832905 | Completed

• 1 other identifier: EnChuKongH_MCM
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Keywords

Wearables, Case Management, Mobile-assisted care

Outcome Measures

Primary Outcomes (1)

• PDSS score

  Panic severity score

  through study completion, an average of 1 year

Secondary Outcomes (3)

• STAI score

  through study completion, an average of 1 year

• BDI score

  through study completion, an average of 1 year

• BAI score

  through study completion, an average of 1 year

Study Arms (2)

Experiment (observational) group with Mobile and Wearable-assisted Case Management (MCM)

MCM involves the integration of mobile technology, such as smartphones and wearable devices, to supplement TAU. This approach is designed to provide additional support and monitoring to patients through the use of mobile applications and remote contact with healthcare professionals. In this study, MCM was implemented alongside TAU, with patients receiving pharmacotherapy, CBT, and mobile-assisted case management services. The MCM component consisted of regular contact with case managers via telephone and a dedicated mobile application.

Behavioral: Mobile and Wearable-assisted Case Management

Control group (TAU)

TAU refers to the standard care provided to patients with panic disorder, which typically includes a combination of pharmacotherapy and psychological or behavioral treatment. In the context of this study, TAU consisted of pharmacological interventions, such as prescribing anxiolytic or antidepressant medications, and psychological interventions, primarily Cognitive Behavioral Therapy (CBT). The administration of TAU was conducted by qualified healthcare professionals who followed established clinical guidelines and treatment protocols to ensure the appropriate management of panic disorder symptoms.

Behavioral: Mobile and Wearable-assisted Case Management

Interventions

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

Control group (TAU); Experiment (observational) group with Mobile and Wearable-assisted Case Management (MCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from outpatient clinics with a main diagnosis of Panic disorder

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• En Chu Kong Hospital: lead
• National Taiwan University: collaborator

Study Sites (1)

En Chu Kong Hospital

Sanxia District, New Taipei City, 237, Taiwan

Location

Related 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.

  PMID: 35166679 BACKGROUND

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• ECKIRB IRB

  En Chu Kong Hostpial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 27, 2023
• Study Start: June 15, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)