UMIN-ICDS Clinical Trial

Basic information
Public title	Self-compassion and Mindfulness integrated online program for Living with Eczema - A randomize controlled trial (SMiLE Study)
Acronym	SMiLE Study
Scientific Title	Self-compassion and Mindfulness integrated online program for Living with Eczema - A randomize controlled trial (SMiLE Study)
Scientific Title:Acronym	SMiLE Study
Region	Japan

Condition
Condition	atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study will be conducted to evaluate the effectiveness of the mindfulness and self-compassion integrated online psychoeducation program for people with atopic dermatitis using RCT design.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease specific quality of life, DLQI-J. Outcomes will be measured at baseline, mid-term, post-intervention, 4-week follow-up, and 26-week follow-up (26-week is only for intervention group).
Key secondary outcomes	Patient Oriented Eczema Measure (POEM), Itch related scales, Self-Compassion Scale (SCS-J), Freiburg Mindfulness Inventory, Hospital anxiety and depression scale(HADS) , Internalized Shame Scale, treatment adherence, home practice, and program feedback

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	8-week mindfulness and self-compassion online group sessions once weekly, 90 min per session
Interventions/Control_2	Waitlist
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Fulfilling all of the following inclusion criteria: 1) >=18 yo <65 yo 2) Have been diagnosed with atopic dermatitis 3) Under treatment/observation and feeling itchy skin 4) >=6 score of Dermatology Life Quality Index at baseline 5) Have internet access to participate in online format program 6) Attend all the sessions and home practice 7) Voluntary participation and comprehension of the purpose or risks of this study
Key exclusion criteria	Either: 1) Under Dupixent treatment at enrollment or prior to 4-week follow-up assessment 2) Psychosis, personality disorder, PTSD, acute stress disorder or Developmental disability 3) Under mental health treatment for other diagnosis, and the therapist considers participation would be inappropriate 4) Under psychotherapy treatment at enrollment or prior to 4-week follow-up assessment 5) Have attended mindfulness or compassion programs, or will attend prior to 4-week follow-up assessment 6) Inability to understand Japanese 7) This study's researchers or their family members 8) Individuals whom researchers judge to inappropriate to participate in this study
Target sample size	116

Research contact person
Name of lead principal investigator	1st name Sanae Middle name Last name Kishimoto
Organization	Kyoto University
Division name	Graduate School of Public Health
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	info@smilestudy.jp

Public contact
Name of contact person	1st name Sanae Middle name Last name Kishimoto
Organization	Kyoto University
Division name	Graduate School of Public Health
Zip code	606-8501
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Homepage URL	https://smilestudy.jp
Email	info@smilestudy.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Mental Health Okamoto Memorial Foundation Pfizer Health Research Foundation KDDI Foundation Grant-in-Aid for Scientific Research, Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	2019 Year 03 Month 22 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	No longer recruiting
Date of protocol fixation	2019 Year 01 Month 18 Day
Date of IRB	2019 Year 03 Month 08 Day
Anticipated trial start date	2019 Year 03 Month 22 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 22 Day
Last modified on	2022 Year 10 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041318