UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036277 |
|---|---|
| Receipt number | 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 | 2022/10/09 13:05:37 |
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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
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
info@smilestudy.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041318
