UMIN-CTR Clinical Trial

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
Email	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
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	Keio University School of Medicine, Institutional Review Board
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-3353-1211
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035892