UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of mindfulness for health professionals building resilience and compassion:MHALO program
Title of the study (Brief title)	MHALO program
Region	Japan

Condition
Condition	not condition
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to develop a mindfulness program to improve resilience and improve burnout for healthcare workers involved in palliative care and to examine the possibility of its implementation
Basic objectives2	Others
Basic objectives -Others	0thers
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Maslach Burnout Inventory
Key secondary outcomes	Five Facet Mindfulness Scale Mindfulness Attention Awareness Scale the Connor-Davidson Resilience Scale Self-Compassion Scale Satisfaction With Life Scale Profile of Mood States Perceived Stress Scale Japanese Interpersonal Reactivity Index

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	mindfulness
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Health care workers Those who have no history of mental illness in the past or who have a recovery period of 2 years or more even if there is a past history Those who can be judged by the research director that there is no hindrance to participation in research even if there is a physical disorder
Key exclusion criteria	Those who have obviously difficult follow-up for six months after the start of intervention History of past mindfulness intervention Those who are judged by the person in charge of the practice that there are serious physical disorders and it is difficult to participate in the study
Target sample size	30

Research contact person
Name of lead principal investigator	Daisuke Fujisawa
Organization	Keio University
Division name	Faculty of Medicine
Address	35 Shinanomachi Shinjyukuku Tokyo
TEL	03(3353)1211
Email	dai_fujisawa@yahoo.co.jp

Public contact
Name of contact person	Sunre Park
Organization	Keio University
Division name	Faculty of Nursing and Medicine care
Address	35 Shinanomachi Shinjyukuku Tokyo
TEL	03(3353)1211
Homepage URL
Email	spak@sfc.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	The Yuumi Memotial foundation for Home Health Care
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	2017 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2017 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029252