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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036277
Receipt No. R000041318
Scientific Title Self-compassion and Mindfulness integrated online program for Living with Eczema - A randomize controlled trial (SMiLE Study)
Date of disclosure of the study information 2019/03/22
Last modified on 2019/06/27

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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
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 Open public 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
2022 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
2019 Year 06 Month 27 Day


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

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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