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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043814
Receipt No. R000050000
Scientific Title Optimizing cognitive behavioral therapy for depression management in psychiatric care study
Date of disclosure of the study information 2021/04/02
Last modified on 2021/04/02

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Basic information
Public title Optimizing cognitive behavioral therapy for depression management in psychiatric care study
Acronym INITIATE Study
Scientific Title Optimizing cognitive behavioral therapy for depression management in psychiatric care study
Scientific Title:Acronym INITIATE Study
Region
Japan

Condition
Condition Major depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and acceptability of web-based cognitive behavioral therapy blended with face-to-face or videoconference sessions for major depression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate (defined as 50% reduction of baseline Quick Inventory of Depressive Symptomatology: QIDS) and dropout rate at 16wk
Key secondary outcomes 1. Baseline reduction score of QIDS at 16,32wks (post randomization)
2. Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Sheehan Disability Scale (SDISS), Client satisfaction questionnaire (CSQ-8j), WHO Health and Work Performance Questionnaire (HPQ): 0,16,32wks
3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session
4. Credibility/ Expectancy Questionnaire (CEQ): 0wk
5. Incremental cost-effectiveness ratio (ICER)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 16 weeks of web-based cognitive behavioral therapy blended with face-to-face or videoconference sessions for major depression in addition to treatment as usual
Interventions/Control_2 16 weeks of treatment as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) having a diagnosis of DSM-IV Major Depressive Disorder
2) QIDS>=11
3) have a smartphone, tablet, or personal computer that can connect to the internet
4) can attend session more than 8
5) 20 years old <= age <=70 years old
6) obtain written consent
Key exclusion criteria 1) No alcohol or substance use disorder in 12 months prior to the screening
2) No history or concurrent hypomanic episode, manic episode or psychotic disorders
3) No other primary DSM-IV Axis I Disorders at screening
4) No serious suicidal ideation at screening
5) No organic brain lesions or major cognitive deficits in a year prior to the screening
6) No severe or unstable medical co-morbidities at screening
7) No structured psychotherapy during the intervention
8) Other relevant reason decided by the principal investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Atsuo
Middle name
Last name Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3235
Email anakagawa@keio.jp

Public contact
Name of contact person
1st name Atsuo
Middle name
Last name Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Homepage URL
Email initiate.cbt@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyorin University
Ehime University
Hokkaido University
Kyushu University
Hiroshima University
Kanazawa Medical University
St. Marianna University
National Hospital Organization Tokyo Medical Center
Heartland Shigisan
Shigisan Mental Clinic Gakuenmae
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学医学部・慶應義塾大学病院 (東京都) 、杏林大学医学部付属病院 (東京都)、愛媛大学医学部附属病院 (愛媛県)、北海道大学病院 (北海道)、九州大学病院 (福岡県) 、広島大学病院 (広島県)、金沢医科大学病院 (石川県)、聖マリアンナ医科大学病院 (神奈川県)、独立行政法人国立病院機構 東京医療センター(東京都)、一般財団法人 信貴山病院 ハートランドしぎさん (奈良県)、医療法人社団ハートランド しぎさんメンタルクリニック学園前(奈良県)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 01 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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