The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from Baseline Depression at 8 weeks
研究概览
简要总结
Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms.
A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks.
The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged from 18 and above
- •The Edinburgh Postnatal Depression Scale cut-off score of >=9
- •At least 6 weeks, and up to one and half years after childbirth
- •Cantonese-speaking Chinese
排除标准
- •Severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which yoga may be contraindicated), and seizure disorders.
- •Comorbid substance dependence
- •Women with psychotic depression, severe eating disorders, actively suicidal or obsessive-compulsive disorders
- •Known pregnancy
- •A history of bipolar disorder, schizophrenia, brain trauma or organic brain disease, mental retardation, or antisocial personality disorder
- •Practice of mindfulness (in forms of Tai Chi, Qi gong or yoga etc.) more than twice a week during the previous three months.
研究组 & 干预措施
Mindfulness-based intervention
干预措施: Mindfulness-based program (MBI-p-R) (Behavioral)
Booklet-based psychoeducation group
干预措施: Booklet-based psychoeducation (Behavioral)
结局指标
主要结局
Change from Baseline Depression at 8 weeks
时间窗: Change from baseline to 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from 8 weeks Depression at 3 months
时间窗: Change from 8 weeks to 3 months
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
次要结局
- Change from Baseline Anxiety at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Anxiety at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Stress at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Stress at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Executive Function at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Executive Function at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Attention at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Attention at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Working Memory at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Working Memory at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Role Functioning at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Role Functioning at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Visual-Motor Coordination at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Visual-Motor Coordination at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Quality of Life at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Quality of Life at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Sleep Quality at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Sleep Quality at 3 months(Change from 8 weeks to 3 months)
- Change from Baseline Mindfulness Levels at 8 weeks(Change from baseline to 8 weeks)
- Change from 8 weeks Mindfulness Levels at 3 months(Change from 8 weeks to 3 months)
研究者
Dr. Jingxia Lin
Research Officer
The University of Hong Kong