What question did this study set out to answer?

This study aims to evaluate the efficacy of mindfulness-based interventions as adjunct therapy for adults with generalized anxiety disorder on pharmacotherapy.

April 27, 2026Open Access

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

Key Points

This study aims to evaluate the efficacy of mindfulness-based interventions as adjunct therapy for adults with generalized anxiety disorder on pharmacotherapy.
Randomized controlled trial involving 106 adults diagnosed with GAD on stable pharmacotherapy.
Participants were assigned to an 8-week mindfulness intervention group or a control group receiving psychoeducation.
Primary outcome measured was anxiety severity on the HAMA scale, analyzed using linear mixed-effects models.
The intervention group showed a significant reduction in HAMA scores (18.6 vs. 22.5; P < 0.05).
Secondary outcomes also improved significantly in the intervention group: 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), GAF-M (Estimate = 6.98, P < 0.05).

Abstract

Background 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. Methods 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. Results 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). Conclusion 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. Trial registration 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

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