UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030484 |
|---|---|
| Receipt number | R000034779 |
| Scientific Title | Self-compassion and Mindfulness Integrated psychoeducation program for Living with Eczema and pruritus (SMILE) |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2019/01/04 11:20:13 |
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Basic information
Public title
Self-compassion and Mindfulness Integrated psychoeducation program for Living with Eczema and pruritus (SMILE)
Acronym
SMILE
Scientific Title
Self-compassion and Mindfulness Integrated psychoeducation program for Living with Eczema and pruritus (SMILE)
Scientific Title:Acronym
SMILE
Region
| Japan |
Condition
Condition
atopic dermatitis and pruritus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will be conducted to investigate the feasibility and effects of the program for people with atopic dermatitis and other itchy skin symptoms.
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 and Skindex-16
Outcomes will be measured at baseline, mid-term, post-intervention, 4-week follow-up, and 12-week follow-up.
Key secondary outcomes
Itch related scales, Patient Oriented-SCORAD (PO-SCORAD), Self-Compassion Scale (SCS-J), Mindfulness attention awareness scale(MAAS), Hospital anxiety and depression scale(HADS) and Adherence
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
8-week mindfulness and self-compassion online group sessions once weekly, 90 min per session
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Fulfilling all of the following inclusion criteria:
1) >=18 yo <60 yo
2) Have been diagnosed with atopic dermatitis or other pruritus
3) Under treatment/observation and feeling itchy skin
4) Have internet access to participate in online format program
5) Attend all the sessions and home practice
6) Voluntary participation and comprehension of the purpose or risks of this study
Key exclusion criteria
Either:
1) Psychosis, personality disorder, PTSD, or acute stress disorder
2) Under psychotherapy treatment
3) Have attended mindfulness or compassion programs
4) Inability to understand Japanese
5) This study's researchers or their family members
6) Individuals whom researchers judge to inappropriate to participate in this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sanae Kishimoto |
Organization
Kyoto University
Division name
Graduate School of Public Health
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
kishimoto.sanae.75w@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sanae Kishimoto |
Organization
Kyoto University
Division name
Graduate School of Public Health
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
Homepage URL
kishimoto.sanae.75w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Mental Health Okamoto Memorial 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
Address
Tel
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 | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034779
