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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030484
Receipt No. 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

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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
Email 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
Email kishimoto.sanae.75w@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034779

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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