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Mindfulness-based intervention for patients with generalized anxiety disorder: a randomized controlled trial
Cancan Zhang1, Jin Zhang1, Lei Sun1
1Psychiatry department, Tianjin Anding Hospital, Tianjin, China.
Frontiers in Psychiatry
|May 11, 2026
Summary
Mindfulness-Based Interventions (MBI) significantly reduced anxiety and improved multiple outcomes in Generalized Anxiety Disorder (GAD) patients receiving pharmacotherapy. This supports MBI integration for enhanced recovery in GAD treatment.
Area of Science:
- Psychiatry and Behavioral Sciences
- Clinical Psychology
- Pharmacological Treatments
Background:
- Generalized Anxiety Disorder (GAD) is a prevalent condition with growing interest in adjunctive treatments.
- Evidence for the efficacy of mindfulness-based interventions (MBI) alongside pharmacotherapy for GAD remains limited.
- This study investigated the effectiveness of MBI as an add-on therapy for adults with GAD.
Purpose of the Study:
- To evaluate the efficacy of an 8-week MBI as an adjunct to pharmacotherapy in adults with GAD.
- To assess the impact of MBI on multidimensional outcomes, including anxiety severity, mindfulness skills, sleep quality, cognitive bias, and psychosocial functioning.
- To determine if MBI offers benefits beyond standard pharmacotherapy for GAD.
Main Methods:
- A randomized controlled trial involving 106 adults diagnosed with DSM-5 GAD on stable pharmacotherapy.
- Participants were assigned to either an 8-week group-based MBI (Mindfulness-Based Cognitive Therapy adapted) plus pharmacotherapy or pharmacotherapy plus a structured psychoeducation control group.
- Outcomes were measured using the Hamilton Anxiety Rating Scale (HAMA), Self-Rating Anxiety Scale (SAS), Five Facet Mindfulness Questionnaire (FFMQ), Pittsburgh Sleep Quality Index (PSQI), Negative Cognitive Processing Bias Questionnaire (NCPBQ), and Global Assessment of Functioning-Modified (GAF-M).
Main Results:
- The MBI group showed significantly greater reductions in clinician-rated anxiety (HAMA) compared to the control group (P < 0.05).
- Significant improvements favoring the MBI group were observed across all secondary outcomes: self-reported anxiety (SAS), mindfulness skills (FFMQ), sleep quality (PSQI), negative cognitive bias (NCPBQ), and psychosocial functioning (GAF-M) (P < 0.05).
- A significant group × time interaction indicated sustained benefits of the MBI intervention.
Conclusions:
- An adjunctive 8-week MBI significantly reduces anxiety symptoms in medicated GAD patients.
- MBI enhances mindfulness, improves sleep quality, modulates negative cognitive bias, and boosts psychosocial well-being in individuals with GAD.
- These findings advocate for the integration of structured MBI into standard GAD care to optimize functional recovery and symptom management.
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01:30Generalized Anxiety Disorder
Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry that persists for at least six months, significantly interfering with daily functioning. Unlike situational anxiety, which arises in response to specific stressors, GAD often occurs without a clear cause. Individuals may experience disproportionate worry about work, health, or relationships. For instance, a person might continuously fear poor health despite normal medical evaluations or...
01:22Behavior Therapy
Behavior therapy incorporates diverse techniques rooted in classical conditioning principles to address maladaptive behaviors and anxiety disorders. These methods aim to reduce avoidance behaviors, foster adaptive coping mechanisms, and alter associations between stimuli and responses, making them effective in a wide range of therapeutic contexts.
Exposure therapy is a cornerstone of behavioral treatment for anxiety disorders. It involves systematic exposure to feared stimuli, either in real...
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01:18Anxiety: Overview
Anxiety is a common mental disorder featuring excessive worry, fear, and apprehension, significantly affecting daily life. People with anxiety disorders experience persistent and intense anxiety, interrupting their everyday functioning.
Individuals with anxiety often experience a range of physical and emotional symptoms, including sweating, trembling, tachycardia, and disturbances in sleep patterns. These symptoms vary in intensity and frequency but are generally disruptive and distressing.
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