UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Self-compassion and Mindfulness Integrated psychoeducation program for Living with Eczema and pruritus (SMILE)
Title of the study (Brief title)	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	Sanae Kishimoto
Organization	Kyoto University
Division name	Graduate School of Public Health
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	Sanae Kishimoto
Organization	Kyoto University
Division name	Graduate School of Public Health
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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