Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for Late-Life Depression: An RCT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS) score
研究概览
简要总结
Study Design & Recruitment: Phase III randomized controlled trial (RCT) with 100-110 patients. Participants >60 years old, with symptoms of late-life depression (LLD; MADRS score>=10), excluding dementia and other psychiatric comorbidities, will be recruited in Montreal and via social media, across Canada.
Interventions: Mindfulness-based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) for 8-weeks, in addition to treat as usual (TAU). MBCT and HEP will have the same group sizes, meeting frequency, and amount of home practice. HEP is a recognized active control where participants learn about diet and exercise, but not meditation.
详细描述
Late life depression (LLD) affects 5 million American seniors yearly with $1.81 billion in direct health-care costs. Biomarkers of LLD have consistently been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression, ameliorating cognitive deficits and preventing decline in older adults by targeting brain circuits implicated in memory and attention. While preliminary findings are promising, the effects of mindfulness delivered through virtual videoconferencing platforms have not been assessed in older adults with depression. This proposed research aims are:
Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of LLD and quality of life compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1(A): The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls. Hypothesis 1(B): The MBCT group will have higher scores of quality of life (EQ-5D) scores at 8-weeks.
Secondary Objective: To investigate the effects of MBCT on cognitive function in LLD. Hypothesis 2: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks.
Exploratory Objective: To investigate effects of MBCT on scores of anxiety (GAD-7) and mindfulness presence (Five-Factor Mindfulness Questionnaire (FFMQ) Hypothesis 3(A): The MBCT group will have reduced scores in the Generalized Anxiety Disorder 7 (GAD-7) at 8-weeks, compared to HEP controls. Hypothesis 3(B): The MBCT group will have a higher score in mindfulness presence (FFMQ), compared to HEP controls.
One-hundred (n =100) patients with LLD will be recruited at various centres in Montreal and throughout Canada via social media. Participants will undergo stratified randomization to either MBCT or Health Enhancement Program (HEP) intervention groups. The investigators will assess changes in (1) depression symptoms and quality of life, (2) processing speed and executive functioning, (3) anxiety and mindfulness presence, at baseline (0 weeks), post intervention (8 weeks), after baseline. Raters and clinicians will be blinded to group allocation while participants will be blinded to the study hypotheses.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline
- •Ability to provide informed consent (shown as to be able to explain back to the research assistant the purpose of the study as well as voluntary participation, rights, time commitments, etc.)
- •participants who have access to internet and basic digital skills to use their computer/tablet
- •willing and able to attend ≥75% of MBCT or HEP sessions
- •adequate understanding of English or French
- •ability to sit for 90 minutes without discomfort
- •willing to inform if any change is made to their psychotropic medications and dosage for the first 8 weeks of the study
排除标准
- •cognitive deficits at baseline, as defined by MoCA score <19
- •diagnosis of post-traumatic stress disorder, bipolar I or II disorder, primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder), and/or severe personality disorder interfering with ability to function in a group setting intervention on a regular basis
- •substance abuse within the past 6 months
- •high suicide risk (e.g., active suicidal ideation and/or recent intent or plan)
- •significant visual or hearing impairment
- •significant impairments in fine motor skills
- •any medical illnesses that could prevent the participant from engaging in the intervention
- •history of psychiatric hospitalization in the last 3 months
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy
Online group sessions 90minutes/week, for 8 weeks, and amount of home practice (~30 mins/day, 6 days/week), based on the manualized protocol developed by co-I Dr. Segal and will be delivered by social workers (or equivalent) with ≥3 years of experience delivering MBCT and training for official certification from the Center for Mindfulness Studies (Toronto).
干预措施: Mindfulness-Based Cognitive Therapy (Behavioral)
Health Enhancement Program
Online group sessions 90minutes/week for 8 weeks, and amount of home practice (~30 mins/day, 6 days/week). HEP will be delivered by social workers (or equivalent) who have received the official training course from HEP's developers at the University of Wisconsin.
干预措施: Health Enhancement Program (Behavioral)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS) score
时间窗: 8 weeks
Depression Symptoms, score results suggest mild, moderate or sever depression
次要结局
- Quality of Life 5 dimensions(8 weeks)
研究者
Soham Rej MD, MSc
Principal Investigator
Lady Davis Institute