UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043814 |
|---|---|
| Receipt number | 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 | 2022/09/15 16:23:38 |
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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), 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
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
initiate.cbt@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050000
