A lifestyle modification program (LMP) had little effect during the COVID-19 lockdown among patients with treatment-resistant depression (TRD) relative to mindfulness-based cognitive therapy (MBCT) or a control condition. These findings were published in Psychiatry Research.
This pragmatic, parallel-group, randomized control trial was conducted at the Health Research Institute of the Balearic Islands in Spain between 2020 and 2021. Patients (N=94) with TRD were randomized in a 1:1:1 ratio to receive placebo (n=31), MBCT (n=29), or LMP (n=34). The placebo comprised written advice about best lifestyle practices, the MBCT comprised an 8-week online mindfulness program plus placebo, and LMP comprised an 8-week online lifestyle promotion program plus placebo. The primary outcome was the change in Beck Depression Inventory II (BDI-II) score at 12 months.
The study population comprised patients with a mean age of 48.15 (SD, 13.055) years, 75% were women, with depression onset at 27.2 (SD, 12.56) years of age, the current episode of depression had lasted 43.28 (SD, 36.65) weeks, and the BDI-II score at baseline was 34.90 (SD, 11.27) points.
Compared with placebo, the change in BDI-II scores did not differ for the MBCT group at 2 (P =.252), 6 (P =.511), or 12 (P =.476) months nor did they differ for the LMP group at 2 (P =.092), 6 (P =.315), or 12 (P =.859) months.
For secondary outcomes, the MBCT group had a significantly higher European quality-of-life 5 dimension questionnaire (EQ-5D VAS) score compared with placebo (β, 18.44; 95% CI, 2.21-34.67; P =.027) and the LMP group had a significantly higher EQ-5D VAS score (β, 19.00; 95% CI, 3.55-34.45; P =.017) and Mediterranean diet adherence screener (MEDAS) score (β, 1.52; 95% CI, 0.75-2.28; P <.001) compared with placebo.
During the study, 7 of the placebo, 6 of the MBCT, and 3 of the LMP recipients increased their antidepressant dose (Χ2, 6.63; P =.036).
This study was limited, as the target sample size was not reached due to the COVID-19 pandemic and the lockdowns likely affected the participant’s ability to engage in social and physical activities.
Study authors concluded, “The results of the present study of patients with TRD showed that the group which received LMP as an adjunctive online program did not achieve a better outcome in terms of depressive symptoms than the MBCT or placebo groups. […] The COVID-19 pandemic likely influenced our results, making it necessary to reexamine this topic in the absence of a pandemic lockdown.”
Garcia A, Yáñez AM, Bennasar-Veny M, et al. Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: a randomized controlled trial. Psychiatry Res. 2022;319:114975. doi:10.1016/j.psychres.2022.114975