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Mindfulness-Based Intervention Reduces Anxiety in GAD Patients on Stable Pharmacotherapy

Mindfulness-Based Intervention Reduces Anxiety in GAD Patients on Stable Pharmacotherapy
Photo by Navy Medicine / Unsplash
Key Takeaway
Consider MBI as an adjunct to pharmacotherapy for GAD, but interpret results cautiously due to truncated p-value and unreported effect size.

This randomized controlled trial evaluated the efficacy of an 8-week group-based Mindfulness-Based Intervention (MBI) adapted from Mindfulness-Based Cognitive Therapy as an adjunct to ongoing pharmacotherapy in adults with DSM-5 Generalized Anxiety Disorder (GAD). The study included 106 participants who were on stable pharmacotherapy and compared MBI plus pharmacotherapy to structured psychoeducation plus pharmacotherapy.

The primary outcome was change in clinician-rated anxiety severity on the Hamilton Anxiety Rating Scale (HAMA). The intervention group showed a significantly greater reduction in HAMA scores compared to the control group (absolute numbers: 18.6 vs. 22.5). However, the p-value was reported as truncated, and no effect size was provided, limiting the precision of the finding.

Secondary outcomes included self-reported anxiety (SAS), mindfulness skills (FFMQ), sleep quality (PSQI), negative cognitive bias (NCPBQ), and psychosocial functioning (GAF-M). Results for these outcomes were not reported in the available abstract.

Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported. The study also did not specify the specific pharmacotherapy medications used, and key limitations were not described. The follow-up period was 8 weeks, which is relatively short.

Clinically, this trial suggests that adding a structured MBI may provide additional anxiety reduction for GAD patients already on medication. However, the truncated p-value, unreported effect size, and lack of safety data warrant cautious interpretation. Further research with longer follow-up and complete reporting is needed.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BackgroundDespite 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.MethodsIn 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.ResultsThe intervention group demonstrated a significantly greater reduction in HAMA scores post-intervention compared to the control group (18.6 vs. 22.5; P 
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