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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031435
Receipt No. 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 2018/08/24

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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
Middle name
Last name Daisuke Fujisawa
Organization Keio University
Division name Department of Neuropsychiatry, School of Medicine
Zip code
Address 35 Shinano-machi, Shinjuku, Tokyo
TEL 03-3353-1211
Email dai_fujisawa@yhoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sunre Park
Organization Keio University
Division name Faculty of Nursing and Medical Care
Zip code
Address 35 Shinano-machi, Shinjuku, Tokyo
TEL 03-3353-1211
Homepage URL
Email spak@sfc.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

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
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
2018 Year 02 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 23 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
2018 Year 02 Month 22 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035892

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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