Combining Mindfulness-Based Cognitive Therapy With Escitalopram for Cognitive and Emotional Recovery in Older Adults With Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 60 and 77 years.
- •Montreal Cognitive Assessment (MoCA) scores ranging from 5 to
- •Diagnosis of persistent and treatment-resistant depression according to DSM-5 criteria.
- •Maintained consistent use of escitalopram hydrobromide for the previous 6 months.
- •Ability to independently perform daily tasks.
- •Provided written informed consent and willing to adhere to study procedures and follow-up.
排除标准
- •Primary diagnosis of schizophrenia, bipolar disorder, or other significant mental health conditions other than depression.
- •Presence of advanced cancer, end-stage heart disease, or severe liver or kidney dysfunction.
- •Recent history (within 12 months) of substance abuse or addiction.
- •Significant visual or hearing impairments that would hinder participation.
- •Participation in mindfulness therapy or similar CBT within the last year.
- •Language comprehension or expression challenges precluding participation.
研究组 & 干预措施
Experimental: MBCT + Escitalopram Group
Participants received mindfulness-based cognitive therapy (MBCT) in weekly 120-minute group sessions for 12 weeks, in addition to daily oral administration of escitalopram hydrobromide (20mg/day).
干预措施: Mindfulness-Based Cognitive Therapy (MBCT) (Behavioral)
Experimental: MBCT + Escitalopram Group
Participants received mindfulness-based cognitive therapy (MBCT) in weekly 120-minute group sessions for 12 weeks, in addition to daily oral administration of escitalopram hydrobromide (20mg/day).
干预措施: Escitalopram Hydrobromide (Drug)
Active Comparator: Escitalopram Alone Group
Participants received daily oral administration of escitalopram hydrobromide (20mg/day) and served as the control group.
干预措施: Escitalopram Hydrobromide (Drug)
结局指标
主要结局
Change in Cognitive Function
时间窗: Baseline, 6 weeks, 12 weeks
Measured by the Montreal Cognitive Assessment (MoCA). The scale score ranges from 0-30, with higher scores indicating better cognitive function.
Change in Depression Severity
时间窗: Baseline, 6 weeks, 12 weeks
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.
Change in Quality of Life
时间窗: Baseline, 6 weeks, 12 weeks
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.
次要结局
- Clinical Treatment Efficacy Rate(At 12 weeks)
- Incidence of Adverse Events(Baseline, 6 weeks, 12 weeks)
研究者
Yun Zhang
Principal investigator
Tangshan Gongren Hospital