Effects of Buspirone Combined with Mindfulness-Based Cognitive Therapy on Emotional Improvement, Sleep Quality, and Serum Cortisol Level in Patients with Generalized Anxiety Disorder

Background: Buspirone shows a certain efficacy in patients with generalized anxiety disorder (GAD), but its combination therapy with mindfulness-based cognitive therapy (MBCT) remains unclear. To compare buspirone+MBCT versus buspirone alone for GAD in a retrospective cohort.

Methods: According to the treatment regimens, patients were assigned to the experimental group (n=50) to receive 120 minutes of MBCT sessions per week plus buspirone, or the control group (n=50) to receive buspirone only. Comprehensive evaluations were conducted at 5 time points (baseline (Week 0, W0), W1, W2, W4, and W8), including clinician-rated measures (Hamilton Anxiety Scale [HAMA]), self-reported symptoms (Hospital Anxiety and Depression Scale - Anxiety [HADS-A]), sleep parameters (Pittsburgh Sleep Quality Index [PSQI] and Athens Insomnia Scale [AIS]), and morning serum cortisol levels (enzyme-linked immunosorbent assay; μg/mL). Group-by-time effects were modeled with repeated-measures mixed models; 2-sided α=0.05.

Results: The combination therapy demonstrated superior outcomes across all measures from W1 onward (all P < .05). By W8, the experimental group showed significantly greater reductions in HAMA (6.1 ± 1.5 vs. 10.1 ± 1.8, P < .001), HADS-A (4.2 ± 1.6 vs. 5.6 ± 1.8, P < .001), PSQI (5.1 ± 2.0 vs. 7.2 ± 2.2, P < .001), and AIS (2.6 ± 1.5 vs. 3.9 ± 1.6, P < .001). Cortisol levels decreased more substantially in the combination group (209.8 ± 33.1 μg/dL vs. 264.0 ± 48.5 μg/dL, P < .001). Treatment effects emerged rapidly, with significant differences in HAMA (P < .001) and cortisol (P < .001) evident by W1. Adverse events were mild and comparable.

Conclusion: Adding MBCT to buspirone was associated with faster and greater clinical and biomarker improvements; prospective randomized trials are warranted.

Cite this article as: Ma Y, Ge Z, Wu X. Effects of buspirone combined with mindfulness-based cognitive therapy on emotional improvement, sleep quality, and serum cortisol level in patients with generalized anxiety disorder. Psychiatry Clin Psychopharmacol. Published online November 13, 2025. doi:https://doi.org/10.5152/pcp.2025.251242.