This study is a randomized controlled trial designed to investigate the synergistic effects of combining mindfulness-based cognitive therapy (MBCT) with escitalopram hydrobromide versus escitalopram alone on cognitive function, depressive symptoms, and quality of life in older adults diagnosed with treatment-resistant depression (TRD) and cognitive impairment.
Treatment-resistant depression (TRD) in older adults presents a significant clinical challenge, often accompanied by cognitive impairment that affects daily functioning and well-being. While escitalopram is a standard pharmacological treatment, monotherapy may be insufficient for this population. Mindfulness-Based Cognitive Therapy (MBCT) has emerged as a promising psychotherapeutic intervention for depression by promoting awareness and altering negative thought patterns. This study aimed to evaluate if an integrated approach of MBCT plus escitalopram would yield superior outcomes compared to escitalopram alone. A total of 230 older adults with TRD were randomized to either a combined therapy group or a medication-only control group. Assessments of cognitive function (MoCA), depression severity (HAM-D), and quality of life (GQOLI-74) were conducted at baseline, 6 weeks, and 12 weeks to determine the efficacy of the combined intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
230
A group intervention delivered by a psychiatrist and two assistants. Sessions were 120 minutes, once per week, for 12 weeks. Content included mindfulness exercises such as 3-minute breathing space, body scanning, mindfulness walking, meditation, and cognitive therapy techniques to observe connections between thoughts, emotions, and behavior.
Oral administration of escitalopram hydrobromide tablets, 20mg once daily (qd) for the entire 12-week study duration.
Tangshan Gongren Hospital
Tangshan, Hebei, China
Change in Cognitive Function
Measured by the Montreal Cognitive Assessment (MoCA). The scale score ranges from 0-30, with higher scores indicating better cognitive function.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Depression Severity
Measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17). The scale score ranges from 0-52, with lower scores indicating less severe depressive symptoms.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Quality of Life
Measured by the General Quality of Life Index-74 (GQOLI-74). The total score is calculated from 74 items, with higher scores indicating a better quality of life.
Time frame: Baseline, 6 weeks, 12 weeks
Clinical Treatment Efficacy Rate
Categorization of treatment effect as 'Significant', 'Effective', 'Average', or 'Ineffective' based on predefined changes in MoCA, HAM-D, and GQOLI-74 scores. The rate (%) of patients in each category was compared between groups.
Time frame: At 12 weeks
Incidence of Adverse Events
Monitoring and recording of all adverse events (AEs) reported by participants or observed by clinicians throughout the study. AEs were assessed for severity and relationship to the intervention.
Time frame: Baseline, 6 weeks, 12 weeks
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