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 2024/02/02 11:08:32

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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 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

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

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 03 Month 31 Day

Date of closure to data entry

2026 Year 03 Month 31 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

2024 Year 02 Month 02 Day



Link to view the page

Value
https://center6.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