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 |
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
A randomised controlled trial of outpatient Morita therapy for clients with anxiety
Japan |
Anxiety disorders, obsessive-compulsive and related disorders in the DSM-5, or patient/client-reported anxiety equivalent to them.
Psychiatry | Adult |
Others
NO
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)
Efficacy
Exploratory
Explanatory
Phase II
Primary outcome measure: The Generalized Anxiety Disorder (GAD-7)
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?
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Behavior,custom |
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
Control 1: Treatment as usual (TAU) (e.g., consultations, support and advices as usual, routinely prescribed medications)
20 | years-old | <= |
65 | years-old | >= |
Male and Female
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
Active
Individuals who:
- are self-injurious/harming
- are actively suicidal
- are diagnosed with developmental disabilities
140
1st name | mikiko |
Middle name | |
Last name | Kubota |
Hosei University
Graduate School of Social Well-being Studies
194-0298
4342 Aihara-cho, Machida-shi, Tokyo
042-783-4047
m.kubota@hosei.ac.jp
1st name | Saki |
Middle name | |
Last name | Kaneko |
Jikei University School of Medicine
Department of Psychiatry
201-0003
4-11-1, Izumi-Honcho, Komae, Tokyo
03-3480-1151ext.3171
s.kaneko@jikei.ac.jp
Japanese Society for Morita Therapy
Mental Health Okamoto Memorial Foundation
Non profit foundation
Japan
Ken Mental Clinic
Morita Therapy Institute/Kitanishi Clinic
Nihon University
Toho University
Simon Fraser University
Yutenji Matsumoto Clinic
Tokoha University
Japanese Society for Morita Therapy
Jikei University School of Medicine
3-19-18, Nishishimbashi, Minato-ku, Tokyo
03-3433-1111
rinri@jikei.ac.jp
NO
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)
2020 | Year | 08 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 05 | Month | 21 | Day |
2020 | Year | 05 | Month | 22 | Day |
2020 | Year | 09 | Month | 01 | Day |
2025 | Year | 05 | Month | 30 | Day |
2025 | Year | 09 | Month | 30 | Day |
2026 | Year | 03 | Month | 31 | Day |
2027 | Year | 03 | Month | 31 | Day |
2020 | Year | 08 | Month | 01 | Day |
2025 | Year | 02 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046782