UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046679
Receipt No. R000053226
Scientific Title Preliminary Study of Cognitive-Behavior Group Therapy for Depressive Disorders and Anxiety Disorders
Date of disclosure of the study information 2022/01/20
Last modified on 2022/01/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.