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

* 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 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)

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name