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 |
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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
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
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
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
