UMIN-CTR Clinical Trial

Public title

Well-being in patients with mental illness: a cross-sectional and longitudinal analysis using registry data

Acronym

Well-being in patients with mental illness

Scientific Title

Well-being in patients with mental illness: a cross-sectional and longitudinal analysis using registry data

Scientific Title:Acronym

Well-being in patients with mental illness

Region

Japan

Condition

Mental illness

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study will conduct cross-sectional and longitudinal analyses using diverse data collected from patients with various mental health conditions within the Mental Illness Registry. Specifically, this includes Tier I demographic information and Tier IIa detailed data obtained through ePROs using web questionnaires and optional wearable devices.

Basic objectives2

Others

Basic objectives -Others

Using cross-sectional and longitudinal analyses of data, we will identify factors related to well-being, as well as those contributing to changes in well-being.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Well-being indicators: Satisfaction with Life Scale (SWLS) and the UCLA Loneliness Scale (ULS).

Key secondary outcomes

Basic information on research subjects
(Tier I information):
- Demographic information
- Psychiatric diagnosis
- Comorbid conditions
- Allergies
- Family history
- Past medical history
- History of suicide attempts
- Smoking history
- History of problem drinking
- Substance abuse history
- Substance abuse history
- Educational background
- Occupation
- Educational/employment status
- Marital status
- Family composition
- Presence of a caregiver
- Medical history
- Tests (brain imaging/function, blood biochemistry, ECG/X-ray status and presence of abnormal findings)
- Prescription history (5 years)
- Clozapine treatment history
- Non-pharmacological treatment history
- Behavioral restrictions
- Receipt of disability welfare services
(Tier IIa information):
Insomnia Scale (AIS), sleep diary, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition, System and Behavioral Activation System Scale (BIS/BAS), State-Trait Anxiety Inventory (STAI), EuroQol-5D-5L (EQ-5D-5L), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Hyperarousal Scale.
Prescription details/medication history: Prescription/medication history information.

Follow-up information
Treatment status, living environment, presence of cohabitants, marital status, education/employment status, medication adherence, use of disability and welfare services.
Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS), State-Trait Anxiety Inventory (STAI),
EuroQol-5D-5L (EQ-5D-5L), Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The study will include individuals who are registered with the Mental Illness Registry by 31 March 2025.
The selection criteria for the Registry are as follows:
[Selection criteria]
1. Patients with a mental illness (regardless of diagnosis, age or gender) who have received treatment at a medical institution approved to participate in this study as a collaborative research institution and who have provided written consent for registration in this registry.
2. Healthy individuals (regardless of age or gender) who have obtained written consent for registration at a participating medical institution.
This study will also include minors and individuals lacking the capacity to give consent. When minors or individuals lacking capacity to consent participate in the study, consent will be obtained from both the individual and their legal representative.
[Reasons for including minors and individuals lacking capacity to consent]
Minors and individuals lacking capacity to consent are frequently present among those with mental disorders. The aim of this registry is to clarify the circumstances of patients with mental disorders based on real-world data.

Key exclusion criteria

Individuals deemed unsuitable as research subjects by the principal investigator. Furthermore, the exclusion criteria for the Mental Illness Registry are as follows:
[Exclusion Criteria]
- Individuals who are healthy, patients or surrogate decision-makers from whom consent cannot be obtained
- Individuals deemed unsuitable by the attending physician, such as those for whom participation in this study is expected to worsen their condition

Target sample size

2200

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University

Division name

School of Medicine

Zip code

106-0041

Address

7th Floor, Azabudai Hills Mori JP Tower 1-3-1 Azabudai, Minato-ku, Tokyo

TEL

03-5363-3219

Email

tkishimoto@keio.jp

Name of contact person

1st name	Mikiko
Middle name
Last name	Yamauchi

Organization

Keio University

Division name

School of Medicine

Zip code

106-0041

Address

7th Floor, Azabudai Hills Mori JP Tower 1-3-1 Azabudai, Minato-ku, Tokyo

TEL

03-5363-3219

Homepage URL

Email

mikiko.h.yamauchi@keio.jp

Institute

Keio University

Institute

Department

Personal name

Organization

Keio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-5363-3879

Email

ras-shinanomachi@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2024

Year

10

Month

24

Day

Date of IRB

2024

Year

11

Month

25

Day

Anticipated trial start date

2024

Year

11

Month

26

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a secondary analysis of registry data, using existing information. The selection criteria are individuals who were registered in the Mental Illness Registry between 10 January 2020 and 31 March 2025 and who were aged 18 years or over at the time of participation.

Registered date

2025

Year

09

Month

30

Day

Last modified on

2025

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067442