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临床试验/NCT02954250
NCT02954250已完成早期 1 期

Modified Mindfulness Based Cognitive Therapy for the Treatment of Depressive Symptoms and Cognitive Inhibition in Patients at Risk for Suicide: A Pilot Randomized Controlled Trial

Lady Davis Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Fulfillment of initial recruitment goals (first 20 patients)

研究概览

简要总结

Background: According to the World Health Organization, one million people die by suicide each year worldwide and the rate of attempted suicide is ten times greater. A less known fact is that suicide is 3 times more frequent in elderly adults compared to younger counterpart. Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly in particular, remain difficult. Clinical, biological and genetic data suggests that SB may be best understood according to a stress-vulnerability model where, more vulnerable individuals are at increased risk of committing a suicidal act when experiencing (mostly social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.

Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many psychiatric symptoms in many different populations, given that this therapy reduces cognitive creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified Mindfulness Based Cognitive Therapy (MMBCT).

Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people with SB, but also, effective to treat depressive symptoms and suicidal ideation. Additionally, we will explore the changes in cognitive testing.

Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The primary outcomes will examine feasibility and acceptability of the treatment. The secondary outcome measures will scores in HAM-D and we will control for any important covariates differing between groups, (e.g. age, sex, # medical illnesses).

Perspectives: Implementation of these interventions could potentially prevent many consultations to psychiatry/mental health professionals. Increase quality of life, decrease medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging population, this could translate to substantial savings in health costs.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current major depressive episode, major depressive disorder (DSM-V) as per the HAM-D-21 ≥ 10;
  • With no recent psychotropic modifications;
  • History of suicidal ideation and/or personal history of suicide attempt;
  • Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test).

排除标准

  • Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)[48]
  • Acute psychotic symptoms
  • Acute Suicidal intent (within 48-72 hours)
  • Hearing impairment not improved with hearing aids and/or sound amplification
  • Unable to engage in a group meditation for physical or practical reasons
  • Ongoing Active Psychotherapy (e.g. a course of CBT psychotherapy)

结局指标

主要结局

Fulfillment of initial recruitment goals (first 20 patients)

时间窗: within 12 months

次要结局

  • Improvement in the Stroop task performances(over 8-weeks period)
  • Decreases in HAM-D Scale(over 8-weeks period)

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

Dr. Karl Looper

Psychiatrist-in-Chief, Jewish General Hospital; Associate Professor, Dept. of Psychiatry, McGill University; Co-Lead, Geri-PARTy Research Group

Lady Davis Institute

研究点 (2)

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