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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Depressive Disorder
Anxiety Disorder |
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |