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Self-compassion and Mindfulness integrated online program for Living with Eczema - A randomize controlled trial (SMiLE Study)

Self-compassion and Mindfulness integrated online program for Living with Eczema - A randomize controlled trial (SMiLE Study) - SMiLE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036277
Enrollment
116
Registered
2019-03-22
Start date
2019-03-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis

Interventions

8-week mindfulness and self-compassion online group sessions once weekly, 90 min per session Waitlist

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactSanae Kishimoto

Kyoto University Graduate School of Public Health

info@smilestudy.jp075-753-9491

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026