UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046679 |
|---|---|
| Receipt number | 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 | 2022/09/05 10:16:20 |
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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
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
taji0808@gmail.com
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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)
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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 11 | Day |
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 | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053226
