UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041277 |
|---|---|
| Receipt number | R000046782 |
| Scientific Title | A randomised controlled trial of outpatient Morita therapy for clients with anxiety |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2025/02/07 21:26:17 |
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Basic information
Public title
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
Acronym
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
Scientific Title
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
Scientific Title:Acronym
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
Region
| Japan |
Condition
Condition
Anxiety disorders, obsessive-compulsive and related disorders in the DSM-5, or patient/client-reported anxiety equivalent to them.
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of outpatient Morita therapy for the treatment of anxiety disorders, obsessive-compulsive and related disorders in the DSM-5, or patient/client-reported anxiety equivalent to them (but not yet been given a formal diagnosis)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Primary outcome measure: The Generalized Anxiety Disorder (GAD-7)
Key secondary outcomes
Secondary outcome measures:
The Patient Health Questionnaire (PHQ)-9
the Japanese General Health Questionnaire (GHQ-12)
Self-Kindness Subscale of the Self-Compassion Scale
the Japanese version of the Sheehan Disability Scale
The Morita Attitudinal Scale for Arugamama (MASA)
The outcome measures will be routinely administered to both treatment and control groups, at the pre- (1st session), mid- (6th session), and post treatment (12th session) time points. Follow-up administrations of the measures will be conducted only with the treatment group at 3, 6, 12 months post-treatment time points.
Qualitative evaluation: Semi-structured interviews will be conducted with both treatment and control groups at the exact same time points as the administrations of the outcome measures. : Interview questions: (a) What are you anxious about at the present moment?, (b) What was it like for you to take actions? (c) What do you think of yourself now?
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention 1: A standardised and protocolised outpatient Morita therapy
Frequency: Weekly
Number of therapy sessions: 12 over 3 months (minimum), up to 4 months
Duration: 50 minutes per session
Interventions/Control_2
Control 1: Treatment as usual (TAU) (e.g., consultations, support and advices as usual, routinely prescribed medications)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who:
- meet the criteria for Shinkeishitsu (Equivalent to anxiety, and obsessive-compulsive and related disorders in DSM-5), or report anxiety equivalent to them (but not yet been given a formal diagnosis)
- have never received outpatient Morita therapy
- are available and able to attend a total of 12 sessions
Key exclusion criteria
Active
Individuals who:
- are self-injurious/harming
- are actively suicidal
- are diagnosed with developmental disabilities
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | mikiko |
| Middle name | |
| Last name | Kubota |
Organization
Hosei University
Division name
Graduate School of Social Well-being Studies
Zip code
194-0298
Address
4342 Aihara-cho, Machida-shi, Tokyo
TEL
042-783-4047
m.kubota@hosei.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
201-0003
Address
4-11-1, Izumi-Honcho, Komae, Tokyo
TEL
03-3480-1151ext.3171
Homepage URL
s.kaneko@jikei.ac.jp
Sponsor or person
Institute
Japanese Society for Morita Therapy
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
Ken Mental Clinic
Morita Therapy Institute/Kitanishi Clinic
Nihon University
Toho University
Simon Fraser University
Yutenji Matsumoto Clinic
Tokoha University
Name of secondary funder(s)
Japanese Society for Morita Therapy
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）
森田療法研究所・北西クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046782
