SMiLE Randomized Trial Supports Incorporating Mindfulness and Self-Compassion Training into the Treatment Plan for Adult Patients with Atopic Dermatitis

1. Online mindfulness and self-compassion training, in addition to usual dermatologic care, improved the quality of life, disease symptoms, and psychological well-being in adult patients with atopic dermatitis (AD).

2. Mindfulness and self-compassion training are effective therapies for adults with AD.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Atopic dermatitis (AD) is a chronic, relapsing, and inflammatory dermatosis. AD is multifactorial, with intense itching being a prominent symptom. Among skin diseases, patient quality of life (QOL) is reported to be the lowest for AD. Mindfulness self-compassion (MSC) training was developed in 2010, after mindfulness-based stress reduction (MBSR) and has been used by general and clinical populations to help in QOL. MBSR focuses on stress management, whereas MSC focuses on patients’ relationships with themselves during suffering. Therefore, this randomized control trial evaluated the QOL outcome of online group mindfulness and self-compassion training for adults with AD. Of the 107 participants, patients in the mindfulness and self-compassion training group had significantly higher DLQI improvement scores than the control waiting list group. Eczema severity, itch- and scratching-related visual analog scales, self-compassion, mindfulness, psychological symptoms, and participant adherence to dermatologist-advised treatments were more advantageous in the intervention group compared to the control. There were few patient dropouts, and there was high internal validity. Some limitations included low external validity (e.g., only Japanese participants applied to the study) and the use of only one therapist. Furthermore, no objective outcomes were evaluated as the trial focused on patient-reported outcomes. The waiting list control group may have contributed to the larger effect size in comparison to using an alternative control such as no treatment or placebo psychotherapy.

Click to read the study in JAMA Dermatology

Relevant Reading: Internet-delivered cognitive behavior therapy for atopic dermatitis: a randomized clinical trial

In-Depth [randomized control trial]: The Self-Compassion and Mindfulness Integrated Online Program for People Living with Eczema (SMiLE) randomized clinical control trial was conducted between March 2019 and October 2022. The QOL outcome following online group mindfulness and self-compassion training for adults with AD was investigated. The primary objective was the Dermatology Life Quality Index (DLQI) change from baseline to week 13. There were six secondary objectives: (1) eczema severity, (2) itch- and scratching-related visual analog scales, (3) self-compassion and all of its subscales, (4) mindfulness, (5) psychological symptoms, and (6) the participant’s adherence to dermatologist-advised treatments. Participants were recruited across Japan outpatient academic medical centres and private practices through social media and study website posts from July 2019 to June 2022. There were six patient inclusion criteria: (1) aged between 18 to 64 years, (2) dermatologist-confirmed AD diagnosis, (3) self-reported criteria of itchy skin and bilateral symmetric eczema with symptoms continuing for greater than 6 months, (4) DLQI > 6, (5) able to access the Internet, and (6) able to attend all sessions and complete home practice. There were seven patient exclusion criteria: (1) administered dupilumab treatment, (2) diagnosed with psychosis, personality disorders, posttraumatic stress disorder, or an acute stress disorder, (3) received psychotherapy during the study, (4) attended other mindfulness or compassion programs, (5) not proficient in Japanese, (6) relative of study researchers, and (7) deemed ineligible to participate by study researchers. Compensation was provided to all participants via online gift cards ($8 for 4-week and 9-week assessments and $16 for the 13-week evaluation). Patients were randomized to the mindfulness and self-compassion group or the waiting list group (1:1 ratio) using block randomization (block size of 4). The block randomization was stratified by sex, age (<30 or ≥ 30 years), and baseline DLQI score (<11 or ≥11 on a 0-30 scale). The therapist and statistician were blinded to the outcome data until trial completion. The mindfulness and self-compassion group was a combination of MBSR and MSC with weekly 9-minute interactive online sessions spanning 8 weeks, an optional 5.5-silent hour meditation retreat (offline or online), and an optional 2-hour Zoom meeting booster session. The 9-minute interactive online sessions were done weekly on the same day and time of the week and included meditation, informal psychoeducation, inquiry, and a short lecture. Furthermore, during COVID-19, the optional retreat was only offered online. The mindfulness and self-compassion training was not solely focused on AD and explored various ways to care for oneself wisely and kindly. All sessions were led by a clinical psychologist with formal MBSR and MSC training and were video-recorded for monitoring facilitation and adherence. Both groups were allowed to continue and receive dermatologic treatment except dupilumab. 1053 patients were assessed for eligibility, 131 consented to participate, and 107 were randomized (mean [SD] age, 36.3 [10.5] years; 85 (79.4%) women, mean [SD] AD duration, 26.6 [11.7] years). The mindfulness and self-compassion group comprised 56 participants, with 55 (98.2%) attending at least 6 of 8 sessions, whereas the waitlist group included 51 participants. Of the 107, 105 participants (98.1%) completed the assessment at 13 weeks. The intervention group had greater DLQI improvement at 13 weeks (between-group difference estimate, −6.34; 95% CI, −8.27 to −4.41; P < .001), with the standardized effect size (Cohen d) at 13 weeks being −1.06 (95% CI, −1.39 to −0.74).  Furthermore, all secondary objectives had greater improvement in the intervention group when compared with the waiting list group. Overall, this randomized clinical trial demonstrated QOL improvement in adults patient with AD after incorporating online mindfulness and self-compassion training into their care management plan.

Image: PD

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