Panic DisorderMCMNCT05832905
Mobile-assisted Case Management for Panic Disorder
An observational study of Panic Disorder, run by En Chu Kong Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Mobile and Wearable-assisted Case Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 159 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2020to 30 Sep 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from outpatient clinics with a main diagnosis of Panic disorder
Who may be able to join
- Diagnosis of panic disorder by DSM5
- More than 18 years old
- An essential ability to navigate smartwatch and mobile phone applications
Who cannot join
- Current substance abuse
- Cardiopulmonary incapacity
- Incapacity or limited mental capacity
- Acute suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile and Wearable-assisted Case Management for Panic Disorder: An Observational Cohort Study Using Machine Learning and Explainable AI
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.
Read the 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.
- Conditions
- Panic Disorder
- Being tested
- Mobile and Wearable-assisted Case Management
- Keywords
- Wearables, Case Management, Mobile-assisted care
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile and Wearable-assisted Case ManagementBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile and Wearable-assisted Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDSS score
Panic severity score
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
STAI score
The State-Trait Anxiety Inventory
Measured: through study completion, an average of 1 year
BDI score
The Beck Depression Inventory II
Measured: through study completion, an average of 1 year
BAI score
The Beck Anxiety Inventory
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Jun 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Principal investigator, Chanhen Tsai, En Chu Kong Hospital
- Investigators
- ECKIRB IRB, Principal investigator, En Chu Kong Hostpial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832905
- Sponsor's protocol ID
- EnChuKongH_MCM
- Acronym
- MCM
- Status last verified
- Feb 2024
- First submitted
- 26 Mar 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35166679
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile and Wearable-assisted Case Management for Panic Disorder: An Observational Cohort Study Using Machine Learning and Explainable AI
- ClinicalTrials.gov ID
- NCT05832905
- Acronym / sponsor ID
- MCM / EnChuKongH_MCM
- Conditions
- Panic Disorder
- Keywords
- Wearables, Case Management, Mobile-assisted care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment (observational) group with Mobile and Wearable-assisted Case Management (MCM) | – | Behavioral: Mobile and Wearable-assisted Case ManagementMCM 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. |
| Control group (TAU) | – | Behavioral: Mobile and Wearable-assisted Case ManagementTAU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from outpatient clinics with a main diagnosis of Panic disorder
Key inclusion criteria (3 listed)
- Diagnosis of panic disorder by DSM5
- More than 18 years old
- An essential ability to navigate smartwatch and mobile phone applications
Key exclusion criteria (4 listed)
- Current substance abuse
- Cardiopulmonary incapacity
- Incapacity or limited mental capacity
- Acute suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile and Wearable-assisted Case ManagementThe 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 | Behavioural | Control group (TAU), Experiment (observational) group with Mobile and Wearable-assisted Case Management (MCM) |
Primary outcome
PDSS score
Time frame: through study completion, an average of 1 year
Panic severity score
3 secondary outcomes
STAI score
Time frame: through study completion, an average of 1 year
BDI score
Time frame: through study completion, an average of 1 year
BAI score
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 35166679Tsai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ECKIRB IRB principal investigator
En Chu Kong Hostpial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by En Chu Kong Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDSS score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.