UMIN-CTR Clinical Trial

Basic information
Public title	Web-Based Cognitive Behavioral Therapy Blended With Videoconference Face-to-Face Sessions for Major Depression: A feasibility study
Acronym	B-vCBT study
Scientific Title	Web-Based Cognitive Behavioral Therapy Blended With Videoconference Face-to-Face Sessions for Major Depression: A feasibility study
Scientific Title:Acronym	B-vCBT study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety, efficacy and feasibility of Web-Based Cognitive Behavioral Therapy Blended With Videoconference Sessions for Major Depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 12wk 2. Drop-out rate
Key secondary outcomes	1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 24 and 36wk 2. Beck Depression Inventory (BDI-II), Generalized Anxiety Disorder (GAD-7), Ruminative Responses Scale (RRS), Sheehan Disability Scale (SDISS), Cognitive-Behavioral Avoidance Scale (CBAS), Coping Inventory for Stressful Situations (CISS): 0,6,12,24,36 wks 3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session 4. Client satisfaction questionnaire (CSQ-8j): 0, 6,12 wks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Web-Based Cognitive Behavioral Therapy Blended With Videoconference Sessions for Major Depression
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

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 confirmed with the SCID 2) GRID-HAMD-17>=14 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) can 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 manic or psychotic episode 3) No other primary DSM-IV Axis I Disorders at screening 4) No comorbid of antisocial personality disorder 5) No serious suicidal ideation at screening 6) No organic brain lesions or major cognitive deficits in a year prior to the screening 7) No severe or unstable medical co-morbidities at screening 8) No past treatment of individual CBT sessions more than 8 9) No structured psychotherapy during the intervention 10) Other relevant reason decided by the CBT principal investigator
Target sample size	8

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	03-5363-3235
Homepage URL
Email	anakagawa@keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine
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) Keio University School of Medicine, Department of Neuropsychiatry (Tokyo) 国立精神・神経医療研究センター (東京都) National Center of Neurology and Psychiatry (Tokyo)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 31 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	Completed
Date of protocol fixation	2019 Year 04 Month 18 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 06 Month 13 Day
Last follow-up date	2023 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	2019 Year 05 Month 31 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=R000042063