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

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 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


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

Value
https://center6.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