UMIN-CTR Clinical Trial

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), functional disability scale, 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 Nagoya University National Hospital Organization Tokyo Medical Center Heartland Shigisan Shigisan Mental Clinic Gakuenmae Uwajima Hospital Toyosato Hospital Tokyo Adachi Hospital Sakuragaoka Memorial Hospital Aizato Hospital Shin-Abuyama Hospital
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)、名古屋大学医学部附属病院（愛知県）、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)、公益財団法人正光会 宇和島病院（愛媛県）、医療法人社団つくば健仁会 とよさと病院（茨城県）、医療法人財団厚生協会 東京足立病院（東京都）、社会福祉法人桜ヶ丘社会事業協会 桜ヶ丘記念病院（東京都）、社会医療法人あいざと会　あいざと病院（徳島県）、特定医療法人　大阪精神医学研究所　新阿武山病院（大阪府）

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	Enrolling by invitation
Date of protocol fixation	2021 Year 02 Month 24 Day
Date of IRB	2021 Year 03 Month 29 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2026 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	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050000