UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035809
Receipt No. R000040794
Scientific Title An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Acronym An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Scientific Title An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Scientific Title:Acronym An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Region
Japan

Condition
Condition depression, anxiety
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine what are the mechanism variables of eight-week mindfulness group therapy for people who complain of depression and anxiety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Below outcomes after the intervention and at 2-month follow-up
Japanese Version of Beck Depression Inventory-2
Japanese Version of State-Trait Anxiety Inventory
Key secondary outcomes Below outcomes after the intervention and at 2-month follow-up
Japanese Version of Mindful Attention Awareness Scale
Japanese Version of Mind-Wandering Questionnaire
Japanese version of Daydream Frequency Scale
Japanese version of Cognitive Fusion Questionnaire (7-item version)
Japanese version of Acceptance and Action Questionnaire-II

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Eight-week mindfulness program
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

Not applicable
Gender Male and Female
Key inclusion criteria People who complain of depression or anxiety
Key exclusion criteria /being with schizophrenia, ASD, ADHD, OCD, or PTSD
/too severe symptoms to participate in a group therapy, e.g., high suicidal risk
/not permitted to participate by the applicant's attending physician if the participant has an attending physician
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kumano
Organization Waseda University
Division name Faculty of Human Science
Zip code
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113
Email hikumano@waseda.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toru Takahashi
Organization Waseda University
Division name Graduate School of Human Science
Zip code
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113
Homepage URL
Email totakahashi@akane.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 08 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 Completed
Date of protocol fixation
2016 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.