臨床研究等提出・公開システム

Date of registration	July. 14, 2022
Last modified on	July. 01, 2025
Trial ID	jRCT1030220215

Scientific Title	The feasibility of Streamlined Cognitive Behavioral Therapy for depression: A pilot study
Public Title	The feasibility of Streamlined Cognitive Behavioral Therapy for depression: A pilot study

Contact for Scientific Queries	Name	Kuga Hironori
	Affiliation	National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
	Address	Ogawa Higashi 4-1-1, Kodaira, Tokyo 187-8511, Japan
	Telephone	+81-423412711
	E-mail	hirokuga@ncnp.go.jp
Contact for Public Queries	Name	Umemoto Ikue
	Affiliation	National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
	Address	Ogawa Higashi 4-1-1, Kodaira, Tokyo 187-8511, Japan
	Telephone	+81-423412711
	E-mail	iumemoto@ncnp.go.jp

Recruitment status	Not Recruiting


Anticipated date of first enrollment		July. 14, 2022
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Outpatients at the applicable research institutes who meet the diagnostic criteria for depression (using DSM-5) 2. Expressing mild or more severe depressive symptoms (BDI-II score of 11 or above) 3. Those aged 20-64 years
	Exclusion Criteria	1. Psychotic disorder (current) (assessed using MINI) 2. Manic episode (current) (assessed using MINI) 3. Substance use disorder (current, severe) (assessed using MINI) 4. Severe suicidality (assessed using MINI and clinical interview) 5. Those who present problems that potentially hinder the delivery of SCBT
	Age Minimum	20age old over
	Age Maximum	65age old not
Health Condition(s) or Problem(s) Studied		Depression
Intervention(s)		The Streamlined CBT (SCBT) conducted in the current study consists of a total of 12-16, relatively short, face-to-face sessions (Once a week, 15 minutes per session), as well as homeworks to be completed after each session. These homeworks include watching videos via the internet and reading materials.
Primary Outcome(s)		Quick Inventory of Depressive Symptomatology: QIDS-J
Secondary Outcome(s)		Beck Depression Inventory-II; BDI-II EuroQol 5 Dimension MOS 36-Item Short-Form Health Survey

Primary Sponsor	National Center of Neurology and Psychiatry

Source of Monetary Support	Ministry of Health, Labour and Welfare
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethical Committee of National Center of Neurology and Psychiatry
Address	Ogawa Higashi 4-1-1, Kodaira, Tokyo 187-8511, Japan, Tokyo
Telephone	+81-42-341-2712-7828
E-Mail	crb-jimu@ncnp.go.jp
Approval Status	Approval
Date of approval	Nov. 05, 2021

Plan to share IPD	Yes
Plan description	If other research institutions or companies wish to make secondary use of the data from this clinical trials, they must obtain the approval of the principal investigator, prepare a new protocol, etc., and have it reviewed and approved by the Ethics Review Committee. For the secondary use of the data, written informed consent has been obtained from the subjects in this clinical trials.

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 01, 2025	(this page)	Changes
2	July. 03, 2024	Detail	Changes
1	July. 14, 2022	Detail

List of change history