Online Mindfulness-Based Cognitive Therapy vs Health Enhancement Program for Depressive Symptoms in Older Adults: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Depressive symptoms scores
研究概览
简要总结
In Canada, depression affects more than 300,000 adults over the age of 60, which costs the healthcare system an estimated $5 billion each year. Late-life depression (LLD) is associated with more deaths, more physical and mental health problems. LLD is hard to treat, as many people will not respond to treatment and many will stop taking antidepressant medication due to negative side-effects. Unfortunately, common non-medication treatments like cognitive behavioral therapy are often inaccessible because of long (6-12 months) wait times and high costs. In a previous study, we found that an 8-week group mindfulness-based cognitive therapy (MBCT) program improved depressive symptoms more than regular LLD treatment (i.e. antidepressants and/or support counseling). Now, a larger scale study is required to compare MBCT to an active control group. Furthermore, research and clinical experience during and post-Covid pandemic has shown that older adults are nowadays far less likely to participate in in-person intervention studies but appreciate and tolerate Zoom delivery of behavioral interventions. This study will compare the effects of MBCT versus an active control group, Health Enhancement Program (HEP), both delivered by Zoom, to see if it improves symptoms of depression in older adults. The study team plans to recruit approximately 100-120 participants in across Canada, who will be randomly assigned to 8-weeks of either MBCT or HEP, delivered by Zoom. The investigators will observe if these treatments improve depression as well as cognition by conducting in-person cognitive assessments. Currently there is a lack of affordable and accessible non-medication treatments for LLD that can be scaled to reach many people. If successful, Mindfulness may be a potential solution, as it is easily given in groups and is well-tolerated by older adults with LLD.
详细描述
Depression in older adults is associated with increased mortality, physical comorbidity, and neurocognitive decline. Up to 50-80% of patients are resistant to pharmacotherapy. Although psychotherapies such as cognitive behavioral therapy are effective for depression, such treatments are expensive and difficult to access, often with 6-12 month wait lists in Canada. There is a need for innovative non-pharmacological treatments for depression in older adults that are scalable and potentially cost-effective. Mindfulness-Based Cognitive Therapy (MBCT) stands out as a promising solution due to its scalable group format, good tolerability, and growing evidence of its efficacy in treating depression in adults. As well, clinical and research experience since Covid has shown that older adults have been much less likely to participate in in-person behavioral interventions.
Preliminary data in LLD: Our research group completed an 8-week intervention of MBCT (as an adjunct to treatment as usual =TAU) vs. TAU in older adults with depression +/- anxiety symptoms (N=61). MBCT was superior to TAU in improving depression scores (-7.9 (±4.4) vs. -4.0 (±4.7) point change, U = 179.5, p = 0.002), with a large effect size (d = 0.86). Furthermore, the investigators have conducted a number of pilot studies, which have established that older adults can feasibly use and enjoy behavioral interventions via teleconferencing. This study is the next step for a properly powered Phase III RCT (n=100-120) with an active comparator (HEP: Health Education Program) to establish the effectiveness of this novel intervention for LLD.
Research Aims:
Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of depressive symptoms scores compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1A: The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls.
Secondary Objective: To investigate the effects of MBCT on cognitive function in older adults experiencing depression. Hypothesis 2A: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks. Hypothesis 2B: The MBCT group will have higher scores of quality of life (EQ-5D) scores at 8-weeks.
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)
盲法说明
The Investigator and outcome assessors will not be aware of allocation. Randomization and allocation will be conducted by an independent statistician.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
- •MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline.
- •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 T-MoCA score <
- •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
结局指标
主要结局
Depressive symptoms scores
时间窗: 8 weeks
as measured by the Montgomery Asberg Depression Rating Scale
次要结局
- Quality of Life scores(8 weeks)
- Processing Speed(8 weeks)
- Executive Functioning(8 weeks)
研究者
Soham Rej MD, MSc
Professor, Geriatric Psychiatrist, Principal Investigator
Lady Davis Institute