UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary Study of Cognitive-Behavior Group Therapy for Depressive Disorders and Anxiety Disorders
Acronym	CogGr study
Scientific Title	Preliminary Study of Cognitive-Behavior Group Therapy for Depressive Disorders and Anxiety Disorders
Scientific Title:Acronym	CogGr study
Region	Japan

Condition
Condition	Depressive Disorder Anxiety Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the feasibility and safety of Cognitive-Behavior Group Therapy for depressive disorders and anxiety disorders.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Dropout rate based on the following points; 1. Voluntary discontinuation at the request of the patient 2. Discontinuation due to symptom deterioration according to clinical findings 3. Discontinuation due to absence of 3 or more sessions out of total 8 sessions The validity of the judgement of dropout will be determined by the Efficacy and Safety Evaluation Committee.
Key secondary outcomes	Pre and post intervention assessment -Coping stress: CISS (Coping Inventory for Stressful Situation) -Depressive symptom: PHQ-9 (Patient Health Questionnaire-9) -Anxiety symptom: GAD-7 (Generalized Anxiety Disorder) -QOL: EQ5D-5L (European Quality of Life Questionnaire-5 Dimension) -Disability: SDISS (Sheehan Disability Scale) -Satisfaction: CSQ-8 (Client Satisfaction G) -Others: Questionnaire on the use of CBT skill after participating in CBGT

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	Cognitive-Behavior Group Therapy
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. Subjects with DSM-V Depressive Disorder or Anxiety Disorder 2. Subjects with CGIS (Clinical Global Impression) score is 3(mildly ill), 4(Moderately ill) or 5(Markedly ill). 3. Subjects between the ages of 20 and 70 at the time of screening 4. Subjects can obtain written consent
Key exclusion criteria	1. No alcohol or substance use disorder in 24 months prior to the screening. 2. No history or concurrent manic, psychotic episode. 3. No other primary Axis I Disorders in 6 months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious suicidal ideation at screening. 6. Unlikely to attend more than 4 visits during the 8-week trial phase. 7. No treatment of CBT or CBGT within the last year prior to the screening. 8. No organic brain lesions or major cognitive deficits. 9. No severe or unstable medical illness at screening. 10. Other relevant reason decided by the CogGr principal investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Kikuchi
Organization	Keio University, School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-5363-3829
Email	kikuchi.psychiatry@gmail.com

Public contact
Name of contact person	1st name Miyuki Middle name Last name Tajima
Organization	Keio University, School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-5363-3829
Homepage URL
Email	taji0808@gmail.com

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee of Keio University, School of Medicine
Address	35 Shinanomachi Shinjuku-ku, Tokyo
Tel	03-3353-1211 (ex. 62014)
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）

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 20 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	Preinitiation
Date of protocol fixation	2022 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 02 Month 10 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	2022 Year 01 Month 20 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053226

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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