Mindfulness-based intervention for patients with generalized anxiety disorder: a randomized controlled trial.

An 8-week mindfulness-based intervention added to standard medication for generalized anxiety disorder led to greater reductions in anxiety severity and improvements in mindfulness, sleep quality, cognitive bias, and psychosocial functioning compared to medication plus psychoeducation. In a randomized trial of 106 adults on stable pharmacotherapy, the mindfulness group showed significantly lower clinician-rated anxiety scores (18.6 vs. 22.5) and better outcomes on all self-reported measures. The findings suggest that integrating structured mindfulness training into routine care can enhance functional recovery alongside symptom management for medicated GAD patients.

Study at a glance

Abstract

Despite growing interest in mindfulness-based interventions (MBI) for Generalized Anxiety Disorder (GAD), robust evidence for their adjunctive use alongside first-line pharmacotherapy is scarce. This study aimed to evaluate the efficacy of MBI as adjunct to pharmacotherapy in adults with GAD, assessing multidimensional outcomes. In this randomized controlled trial, 106 adults diagnosed with DSM-5 GAD and on stable pharmacotherapy were randomly assigned to intervention group or control group (n=53). The intervention group received an 8-week, group-based MBI adapted from Mindfulness-Based Cognitive Therapy in addition to their ongoing pharmacotherapy. The control group received pharmacotherapy plus an active control condition consisting of structured psychoeducation (n=53). The primary outcome was the change in clinician-rated anxiety severity on the Hamilton Anxiety Rating Scale (HAMA). Secondary outcomes included self-reported anxiety (Self-Rating Anxiety Scale, SAS), mindfulness skills (Five Facet Mindfulness Questionnaire, FFMQ), sleep quality (Pittsburgh Sleep Quality Index, PSQI), negative cognitive bias (Negative Cognitive Processing Bias Questionnaire, NCPBQ), and psychosocial functioning (Global Assessment of Functioning-Modified, GAF-M). Linear mixed-effects model was used for analysis. The intervention group demonstrated a significantly greater reduction in HAMA scores post-intervention compared to the control group (18.6 vs. 22.5; P < 0.05), with a significant group × time interaction (Estimate = -3.68, P < 0.05). Significant between-group improvements favoring the intervention group were also confirmed across all secondary outcomes: SAS (Estimate = -4.29, P < 0.05), FFMQ (Estimate = 20.25, P < 0.05), PSQI (Estimate = -2.36, P < 0.05), NCPBQ (Estimate = -6.75, P < 0.05), and GAF-M (Estimate = 6.98, P < 0.05). An adjunctive, 8-week MBI significantly reduces anxiety and enhances mindfulness, sleep, cognitive function, and psychosocial well-being in medicated GAD patients. These findings support integrating structured MBI into standard care to optimize functional recovery alongside symptom management. The study was registered prior to conducting the research in the Chinese Clinical Trial Registry (https://www.chictr.org.cn) on September 26, 2024 with the trial identification number ChiCTR2400090284.