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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041277
Receipt No. 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 2020/08/01

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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
Email 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
Email s.kaneko@jikei.ac.jp

Sponsor
Institute Japanese Society for Morita Therapy
Institute
Department

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
Hokusho University
Keio University
Nihon University
Toho University
Hijiyama University
Simon Fraser 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
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)
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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 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
2020 Year 08 Month 01 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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