臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 16, 2022
Last modified on	April. 28, 2023
Trial ID	jRCT1030220513

Scientific Title	The Feasibility of Strengths-Based Cognitive Behavioral Therapy for Depression
Public Title	The Feasibility of Strengths-Based Cognitive Behavioral Therapy

Contact for Scientific Queries	Name	Kuga Hironori
	Affiliation	National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
	Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
	Telephone	+81-42-341-2711
	E-mail	hirokuga@ncnp.go.jp
Contact for Public Queries	Name	Komazawa Asami
	Affiliation	National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
	Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
	Telephone	+81-42-341-2712
	E-mail	komazawa@ncnp.go.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Dec. 16, 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	Individuals who are currently undergoing continuous or maintenance treatment at NCNP Those with low awareness or use of their strengths Those who are aged 18 years or older Those who understand the purpose and content of the study and are capable to provide informed consent
	Exclusion Criteria	Individuals with psychotic disorder (current), manic episode (current), substance use disorder, severe suicidality, or other problems that potentially hinder the delivery of strengths-based CBT.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Depression
Intervention(s)		Strengths-based Cognitive Behavioral Therapy (SB-CBT) is conducted in a face-to-face or online individual therapy format for approximately five sessions. If necessary, up to three additional sessions may be conducted. SB-CBT consists of four phases: identifying individual strengths, developing strategies to apply in difficult situations, planning and implementing behavioral experiments, and practicing.
Health Condition(s) Keyword		Depression
Intervention(s) Keyword		Cognitive Behavioral Therapy, CBT, Strengths-based Cognitive Behavioral Therapy, SB-CBT
Health Condition(s) Code		D003863
Intervention(s) Code		D015928
Primary Outcome(s)		Strengths Knowledge Scale and Strengths Use Scale
Secondary Outcome(s)		Quick Inventory of Depressive Symptomatology (QIDS-J) Psychological Well-being Inventory (PWB) EuroQol 5 Dimension (EQ-5D) General Self-Efficacy Scale (GSES) Social Adaptation Self-evaluation Scale (SASS-J) 14-item Resilience Scale (RS-14) Positive and Negative Affect (PANAS) Clinical Global Impression Scales (CGI-S and CGI-I) Client Satisfaction Occurrence of adverse events Rate of dropout Homework Compliance Scale (HCS) Interviews regarding usefulness and satisfaction with the intervention

Primary Sponsor	National Center of Neurology and Psychiatry

Secondary Sponsor

Source of Monetary Support	Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics committee, National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Tokyo
Telephone	+81-42-341-2711
E-Mail	rinri-jimu@ncnp.go.jp
Approval Status	Approval
Date of approval	Aug. 05, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 28, 2023	(this page)	Changes
1	Dec. 16, 2022	Detail

List of change history