跳至主要内容
临床试验/NCT04450147
NCT04450147已完成不适用

Efficacy of Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder: A Pilot Randomized Controlled Trial With an Active Control

Lady Davis Institute1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Change in Depression

研究概览

简要总结

It is expected that by 2030, the percentage of patients with bipolar disorder (BD) in Canada over 60 years of age will exceed 50%. In this population, poor cognition and persistent sub-threshold depressive symptoms are particularly common, difficult to treat, associated with increased mood episodes, and poor daily functioning. Mind-body interventions have increasingly been found to be effective in treating several psychiatric condition including BD. A few pilot studies examining mindfulness-based intervention in younger adult BD have been promising for depressive symptoms, but some pilot research suggest that patients with older age bipolar disorder (OABD) may benefit more from moving mindfulness. The investigators will conduct a 12-week randomized controlled trial to assess whether tai-chi/qigong will be associated with 1) greater reduction in depressive symptoms, and 2) greater improved cognition, in comparison to a light exercise active control condition, 12- and 24-weeks from baseline, in BD patients aged 40+.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged greater than or equal to 40 years
  • •history of diagnosis of bipolar I or II disorder
  • •access to a computer with a functioning camera, microphone, and ability to run Zoom software
  • •English or French speaking
  • •ability to give informed consent

排除标准

  • •Young Mania Rating Scale score > 5
  • •current clinician diagnosis of substance abuse, unless currently in complete remission
  • •risk of suicide as assessed by a score above 3 on item 10 of Montgomery Asberg Depression Rating Scale
  • •participation or plan to participate in any other concurrent psychosocial group program during course of study
  • •unstable psychiatric medication (less than 4-weeks since commencement)

研究组 & 干预措施

Tai Chi and Qigong

Experimental

50mins x 12 weeks of virtually-delivered group tai chi/qigong

干预措施: Tai Chi/Qigong vs. Walking/Stretching (Behavioral)

Walking and Stretching

Active Comparator

50mins x 12 weeks of virtually-delivered group walking and stretching

干预措施: Tai Chi/Qigong vs. Walking/Stretching (Behavioral)

结局指标

主要结局

Change in Depression

时间窗: Baseline, 12-weeks, 24-weeks

Level of depression as measured by the Montgomery-Asberg Depression Rating Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome

次要结局

  • Change in Processing Speed(Baseline, 12-weeks, 24-weeks)

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soham Rej MD, MSc

Geriatric Psychiatrist, Assistant Professor, Principle Investigator

Lady Davis Institute

研究点 (1)

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