臨床研究等提出・公開システム

Date of registration	Oct. 21, 2023
Last modified on	Oct. 21, 2023
Trial ID	jRCT1030230418

Scientific Title	Effectiveness of Group Cognitive Behavioral Therapy for Depression Leave Patients at a Return-to-Work Support Facility--Use of Home Work with ICT-- (Effectiveness of Group Cognitive Behavioral Therapy using ICT)
Public Title	Group cognitive-behavioral therapy to support return to work using ICT (GCBT using ICT)

Contact for Scientific Queries	Name	Matunaga Miki
	Affiliation	Rikkyo University
	Address	1-2-26, Kitano, Niiza, Saitama
	Telephone	+81-48-471-7069
	E-mail	mikim@rikkyo.ac.jp
Contact for Public Queries	Name	Matunaga Miki
	Affiliation	Rikkyo University
	Address	1-2-26, Kitano, Niiza, Saitama
	Telephone	+81-48-471-7069
	E-mail	mikim@rikkyo.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Oct. 20, 2023
Target sample size		60
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	factorial assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. 20 years of age or older 2. they have a desire to return to work 3. they have permission from their doctor to participate in rework
	Exclusion Criteria	1. strong feelings of hopelessness 2. severe physical complications 3. considered to have difficulty in group activities.
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Major depressive disorder
Intervention(s)		A total of 8 sessions of group cognitive-behavioral therapy of approximately 90 minutes will be conducted once a week. Homework (independent assignments) using ICT or paper will be conducted for each session.
Health Condition(s) Keyword		Depression, leave of absence. reinstatement assistance
Intervention(s) Keyword		Cognitive Behavior Therapy, Group Cognitive Behavior Therapy, Homework, ICT
Primary Outcome(s)		Patient Health Questionnaire
Secondary Outcome(s)		Automatic Thoughts Questionnaire-Revised Behavior Activation for Depression Scale Difficulty in Returning to Work Inventory Percentage of homework performed, quantity and quality of homework content, and program attendance

Primary Sponsor	Rikkyo University

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Psychology Research Ethics Committee, Department of Contemporary Psychology, Rikkyo University
Address	1-2-26, Kitano, Niiza, Saitama, Saitama
Telephone	+81-48-471-7069
Approval Status	Approval
Date of approval	Oct. 19, 2023

Name of Certified Review Board	Rikkyo University Ethics and Safety Committee for Research and Experiments Related to Life Sciences
Address	3-34-1, Nishiikebukuro, Toshima,, Saitama
Telephone	+81-3-3985-4589
E-Mail	lifescience@rikkyo.ac.jp
Approval Status	Approval
Date of approval	Oct. 19, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none