臨床研究等提出・公開システム

Date of registration	Sept. 22, 2025
Last modified on	Sept. 22, 2025
Trial ID	jRCT1030250383

Scientific Title	Evaluation and development of comprehensive support and verification of effects of mood disorders in the acute phase centered on cognitive function
Public Title	Evaluation and development of comprehensive support and verification of effects of mood disorders in the acute phase centered on cognitive function

Contact for Scientific Queries	Name	Inamoto Atsuko
	Affiliation	Northern Yokohama Hospital Showa University School of medicine
	Address	35-1,Chigasaki-chuo,Tsuzuki-ku ,Yokohama,Kanagawa
	Telephone	+81-45-949-7000
	E-mail	atsuko2@med.showa-u.ac.jp
Contact for Public Queries	Name	Inamoto Atsuko
	Affiliation	Northern Yokohama Hospital Showa University School of medicine
	Address	35-1,Chigasaki-chuo,Tsuzuki-ku ,Yokohama,Kanagawa
	Telephone	+81-45-949-7000
	E-mail	atsuko2@med.showa-u.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Aug. 31, 2022
Actual date of first enrollment		Aug. 31, 2022
Target sample size		80
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who are hospitalized at the Mental Care Center, Yokohama City Northern Hospital, Showa University, and meet the diagnostic criteria for bipolar disorder or depression of ICD10 (2) Patients between 18 and 75 years of age at the time of obtaining consent (3) Patients who have obtained written consent from the person concerned regarding participation in this research
	Exclusion Criteria	Patients with unstable psychiatric symptoms
	Age Minimum	18age old over
	Age Maximum	75age old not
Health Condition(s) or Problem(s) Studied		mood disorders
Intervention(s)		We will implement a psychological education program centered on improving cognitive impairment. From August 2021, we will use a group psychotherapy program using a complete workbook that contains elements of disease education and cognitive behavior therapy that are effective in previous research in west 2 wards. (Once a week: 1 hour: Tried in multiple occupations such as doctors, mental health workers, nurses, psychologists, occupational therapists, etc.) 6 times in total
Intervention(s) Keyword		psychological education program
Primary Outcome(s)		The amount of changes before and after intervention in neuropsychological data (execution function, linguistic memory, narrative memory, working memory, processing speed, linguistic fluency, social cognition, attention)
Secondary Outcome(s)		Background survey: Gender, age, family structure, employment information, etc. Clinical data: untreated period, disease period, past hospitalizations, number of days of community living, state drug information of medical welfare resources, etc. Clinical indicators: General function evaluation (GAF), cognitive function question assessment (SCoRS-J), depression self-evaluation scale (SDS), Hamilton Depression Evaluation Scale (HAM-D) intelligence test (JART) recovery evaluation (RAS), solution construction scale (SBI-J), etc.

Primary Sponsor	none

Secondary Sponsor

Name of Certified Review Board	Ethics Committee on Human Research, etc. at Showa University
Address	1-5-8 Hatanodai Shinagawa-ku, Tokyo
Telephone	+81-3-3784-8129
E-Mail	ura-ec@ofc.showa-u.ac.jp
Approval Status	Approval
Date of approval	June. 23, 2022

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	none