UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031435 |
|---|---|
| Receipt number | R000035892 |
| Scientific Title | Mindfulness for health professionals building resilience and compassion (MHALO program) - randomized control trial |
| Date of disclosure of the study information | 2018/02/23 |
| Last modified on | 2021/04/16 16:10:17 |
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Basic information
Public title
Mindfulness for health professionals building resilience and compassion (MHALO program) - randomized control trial
Acronym
MHALO program
Scientific Title
Mindfulness for health professionals building resilience and compassion (MHALO program) - randomized control trial
Scientific Title:Acronym
MHALO program
Region
| Japan |
Condition
Condition
Psychological stress, compassion and resilience of medical professionals
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test whether Mindfulness for health professionals building resilience and compassion program (MHALO program) raises resilience and compassion and reduces psychological stress among health professionals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Perceived Stress Scale (PSS)
Key secondary outcomes
Maslach Burnout Inventory (BMI)
Five Facet Mindfulness Questionnaire (FFMQ)
Connor-Davidson Resilience Scale (CD-RISC)
Self-Compassion Scale (SCS)
Satisfaction With Life Scale (SWLS)
Profile of Mood States (POMS)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Health Performance Questionnaire (HPQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness for health professionals building resilience and compassion (MHALO program)
Interventions/Control_2
Mindfulness-based program, comprising a two-day workshop and two half-day follow-up sessions after four and eight weeks
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
- Medical professionals who work in the field of oncology and/or palliative care
- Those who will be able to participate/commit in the whole program
- Those who feels psychological distress or difficulty
- No history of psychiatric illness (including with more than two years of remission)
- Submission of written informed consent
Key exclusion criteria
- Who are unable to be followed up for three months
- Past experience of formal mindfulness-based intervention
- Serious physical illness
- Judged by the research team as ineligible
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujisawa |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
160-8582
Address
35 Shinano-machi, Shinjuku, Tokyo
TEL
03-3353-1211
dai_fujisawa@yhoo.co.jp
Public contact
Name of contact person
| 1st name | Sunre |
| Middle name | |
| Last name | Park |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinano-machi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
spak@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
https://journals.lww.com/jporp/Fulltext/2020/06000/Study_protocol_for_evaluating_the_efficacy_of.4.a
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
| 2018 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035892
