UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052652
Receipt number R000060084
Scientific Title Examination of the therapeutic effects of Morita therapy-based group psychotherapy for anxiety and obsessive-compulsive disorders
Date of disclosure of the study information 2023/11/01
Last modified on 2025/05/06 22:22:45

* 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

Examination of the therapeutic effects of Morita therapy-based group psychotherapy for anxiety and obsessive-compulsive disorders

Acronym

Examination of the therapeutic effects of Morita therapy-based group psychotherapy for anxiety and obsessive-compulsive disorders

Scientific Title

Examination of the therapeutic effects of Morita therapy-based group psychotherapy for anxiety and obsessive-compulsive disorders

Scientific Title:Acronym

Examination of the therapeutic effects of Morita therapy-based group psychotherapy for anxiety and obsessive-compulsive disorders

Region

Japan


Condition

Condition

Social anxiety disorder, Panic disorder, Agoraphobia, Generalized anxiety disorder, Somatic symptom disorder and obsessive-compulsive in the DSM-5.

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of Morita therapy-based group psychotherapy for the treatment of Social anxiety disorder, Panic disorder, Agoraphobia, Generalized anxiety disorder, Somatic symptom disorder and obsessive-compulsive in the DSM-5.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

The Generalized Anxiety Disorder (GAD-7)

Key secondary outcomes

Quantitative research:
Self-Kindness Subscale and Common Humanity Subscale of the Self-Compassion Scale
State Anxiety Subscale of the State-Trait Anxiety Inventory

Physiological indicators:
Breathing rate, standard deviation of NN intervals, coefficient of variation of R-R interval, high frequency spectra and low frequency spectra/HF.

Qualitative evaluation:
Semi-structured interviews


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Duration:12 weeks
Frequency: Biweekly, 90 minutes per session
Number of therapy sessions: 5 sessions and a follow up session
Intervention : Morita therapy-based group psychotherapy

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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Meet the criteria for Shinkeishitsu (Social anxiety disorder, Panic disorder, Agoraphobia, Generalized anxiety disorder, Somatic symptom disorder and obsessive-compulsive in DSM-5).

Key exclusion criteria

- are self-injurious/harming
- are actively suicidal
- are diagnosed with developmental disabilities
- are Persons with organic disease or history of heart disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name SAKI
Middle name
Last name KANEKO

Organization

Jikei University School of Medicine

Division name

Department of Psychiatry

Zip code

201-8601

Address

4-11-1, Izumi-Honcho, Komae, Tokyo

TEL

03-3480-1151

Email

s.kaneko@jikei.ac.jp


Public contact

Name of contact person

1st name SAKI
Middle name
Last name kANEKO

Organization

Jikei University School of Medicine

Division name

Department of Psychiatry

Zip code

201-8601

Address

4-11-1, Izumi-Honcho, Komae, Tokyo

TEL

03-3480-1151

Homepage URL


Email

s.kaneko@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Mental Health Okamoto Memorial Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jikei University School of Medicine

Address

3-19-18, Nishishimbashi, Minato-ku, Tokyo

Tel

03-3433-1111

Email

rinri@jikei.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

東京慈恵会医科大学第三病院森田療法センター(東京都)


Other administrative information

Date of disclosure of the study information

2023 Year 11 Month 01 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

No longer recruiting

Date of protocol fixation

2023 Year 06 Month 09 Day

Date of IRB

2023 Year 06 Month 09 Day

Anticipated trial start date

2023 Year 07 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 09 Month 30 Day

Date trial data considered complete

2024 Year 09 Month 30 Day

Date analysis concluded

2025 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2023 Year 10 Month 30 Day

Last modified on

2025 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060084