Mind–body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial
Authors: Le Rhun A. , Caillet P. , Lebeaupin M. , Duval M. , Guilmault L. , Anthoine E. , Borghi G. , Leclère B. , Moret L. 
Published: September 2023

Abstract
Background
Effective emotional regulation is recognized as essential to a good mental health of people with chronic diseases, and Mind–body and Art Therapies (MBATs) could have a positive effect on emotional regulation skills in this population. Thus, we aimed to evaluate the effect of MBATs on emotional regulation as measured by the Difficulties in Emotion Regulation Scale (DERS) questionnaire.

Methods
A convergent mixed approach nested in a pragmatic superiority two arms parallel randomized controlled trial was conducted. French speaking adults with one or more chronic somatic illnesses and not suffering from a chronic psychiatric disorder unrelated to one of their chronic somatic illness were included. At inclusion, non-directive interviews were conducted, followed by an initial DERS assessment. The same combination of evaluation was implemented after 6 months of activity (T1). After inclusion, each participant was randomized within either the intervention group (G1) or the control group (G2) following a controlled wait-list design by use of a pregenerated randomization list. Staff and patient were blinded to this list until the initial evaluation was completed, after which the trial was conducted in an open-label fashion. Participants chose 2 mediations: one creativity-focused (art-therapy, writing workshop, theatre of life, vocal workshop) and one mind–body-focused (mindfulness meditation, Pilates, shiatsu, ayurvedic massages). G1 started their mediations immediately after inclusion, while G2 started 6 months later. Primary outcome was the change in means at 6 months in the overall DERS score compared between each group. Non-directive interviews were carried out at the inclusion and after 6 months of MBATs. A continuous inductive analysis was carried out on gathered material in G1 to explore the participants' experiences regarding their disease and their perceived changes associated to the intervention.

Results
A total of 150 patients was randomized (75 per groups) at the end of the study. At T1, 133 patients filled out the final questionnaire (67 in G1 vs 66 in G2) and 112 interviews were analysed (54 in G1 vs 58 in G2). All 150 patients were analysed (intention to treat) using a multiple imputation approach. The mean DERS score at T0 was equal to 82.8 ± 21.1 and 85.0 ± 20.2 in G1 and G2 respectively. On average, at T1, the score decreased in the G1 (Δ = -4.8, SD = 21.3) and in G2 (Δ = -0.11, SD = 17.8). The difference in decrease, however, was not statistically significant (p = 0.13). Qualitative analysis underlined some MBATs benefits on emotional regulation, especially on regulation strategies. No harms related to the intervention has been observed.

Conclusions
This study only partially supports benefits on MBAT on emotional regulation skills enhancement in patients with chronic disease receiving MBATs, as measured by the DERS scale.

Trial registration
The protocol was registered on Clinical Trials (NCT02911207).