UMIN-CTR Clinical Trial

Public title

Development of a database, using follow-up web interviews, for the development of solutions aimed at recovery and relapse prevention of mental illness.

Acronym

Development of a database, using follow-up web interviews, for the development of solutions aimed at recovery and relapse prevention of mental illness.

Scientific Title

Development of a database, using follow-up web interviews, for the development of solutions aimed at recovery and relapse prevention of mental illness.

Scientific Title:Acronym

Development of a database, using follow-up web interviews, for the development of solutions aimed at recovery and relapse prevention of mental illness.

Region

Japan

Condition

Depression, bipolar disorder, or schizophrenia

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To build a data base for the creation of various social services that address daily life problems in the process of remission, follow-up interviews using a web conference system will be conducted periodically with patients with depression, bipolar disorder, and schizophrenia who have completed the acute stage of treatment and are undergoing maintenance treatment for recovery and relapse prevention. Interviews will be conducted to listen to their life issues and problems, and to assess their wellbeing and severity of illness.
As a secondary objective, video and audio data from web conferencing will be used to promote recovery and detect signs of recurrence.
Healthy volunteers will also be asked to cooperate in the collection of control data.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Interview information on daily problems, wellbeing, severity assessment, quality of life, physical activity scores, and relapse, remission, or recovery

Key secondary outcomes

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

As patients
1) Patients with depression, bipolar disorder, or schizophrenia who have completed the acute phase of treatment and are undergoing maintenance treatment
2) 18 years old or older
3) Patients who have a smart phone or PC and have access to web conferencing via the Internet (or may have access with family support)
4) Patients who are deemed by the attending physician to be eligible for web conferencing based on the medical condition of the primary disease
5) Decisionally not impaired judged by treating physician.

As healthy subjects
1) Healthy subjects with no history of mental illness
2) 18 years old or older
3) Healthy volunteers who have a smart phone or PC and have access to web conferencing via the Internet (or have access to web conferencing with the support of a family member).

Key exclusion criteria

As patients
1)Patients whose condition may be impaired by participation in this study
2)Those who are considered to be ineligible by the PI or investigators

As healthy subjects
1)Those who are considered to be ineligible by the PI or investigators

Target sample size

400

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio university school of medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellness

Zip code

106-0032

Address

Roppongi Hills North Tower 7F, 6-2-31, Roppongi, Minato-ku, Tokyo

TEL

03-5786-0006

Email

tkishimoto@keio.jp

Name of contact person

1st name	Momoko
Middle name
Last name	Kitazawa

Organization

Keio university school of medicine

Division name

Neuropsychiatric department

Zip code

160-8582

Address

35 Shinanomachi Shinjuku Tokyo

TEL

03-5786-0006

Homepage URL

Email

m.kitazawa@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology Agency
COI-NEXT

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Tokyo Medical and Dental University
Tokyo Institute of Technology

Name of secondary funder(s)

Organization

Research Ethics Committee of Keio University, School of Medicine

Address

35 Shinanomachi Shinjuku Tokyo

Tel

0353633503

Email

med-rinri-jimu@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

慶應義塾大学（東京都）
東京医科歯科大学（東京都）
東京工業大学（東京都）
大泉病院（東京都）
あさかホスピタル（福島県）
鶴が丘ガーデンホスピタル（東京都）
大泉メンタルクリニック（東京都）
あさか台メンタルクリニック（東京都）
長津田いこいの森診療所（神奈川県）
青山メンタルクリニック（東京都）

Date of disclosure of the study information

2022

Year

09

Month

20

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

Enrolling by invitation

Date of protocol fixation

2022

Year

07

Month

13

Day

Date of IRB

2022

Year

08

Month

30

Day

Anticipated trial start date

2022

Year

09

Month

20

Day

Last follow-up date

2027

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1.Research Design
Observational study

2. Recruitment
Regular follow-up interviews (approximately every 3 months) will be conducted with up to 400 subjects using a web conferencing system to interview them about their life challenges and problems in the process of remission, and to assess their wellbeing and severity of illness. Video and audio recordings of the web interviews will be stored and analyzed to promote recovery and detect signs of relapse. These follow-up interviews will be conducted for up to 2 years (1 year for healthy subjects).

3. Outcomes
For depression:
Evaluation of the depressive episode portion of the DSM-5 by the SCID

For bipolar disorder:
Evaluation of the manic episode portion of the DSM-5 using the SCID
The Young Mania Rating Scale (YMRS)

For depression and bipolar disorder:
Hamilton Depression Rating Scale (HAM-D-17)
Montgomery-Asberg Depression Rating Scale (MADRS)

For schizophrenia:
Brief Psychiatric Symptom Rating Scale (BPRS)

For all patients:
Global physical activity questionnaire (GPAQ)
Satisfaction With Life Scale (SWLS)
The Japanese version of the Scale of Positive and Negative Experience (SPANE-J)
EuroQol 5 Dimension (EQ-5D)

For healthy subjects
All the above assessments

Registered date

2022

Year

09

Month

20

Day

Last modified on

2023

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055791