A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- Beck Depression Inventory - II
研究概览
简要总结
The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury.
The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.
详细描述
Major depression is a significant chronic problem for people with traumatic brain injury (TBI), and its treatment is difficult. A promising approach to treat depression is mindfulness-based cognitive therapy (MBCT), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (MBSR) and cognitive behavioural therapy (CBT). This multi-site, randomized, controlled trial of a MBCT intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with TBI. MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic brain injury suffered more than one year ago but less than five
- •Evidence of depression post-traumatic brain injury (Beck Depression Inventory-II score of 16 or greater)
- •Ability to speak and read English
- •Age 18 or more
排除标准
- •Inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (California Verbal Learning Test, Digit Span subsection of Wechsler Adult Intelligence Scale); verbal fluency and executive functioning (Controlled Oral Word Association Test); verbal abstract reasoning (Similarities subsection of Wechsler Adult Intelligence Scale); and executive functioning (Trail Making Test).
- •Evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (Beck Depression Inventory-II and Symptom Checklist-90-R will supplement the decision-making process of study clinicians).
结局指标
主要结局
Beck Depression Inventory - II
时间窗: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.
次要结局
- Philadelphia Mindfulness Scale (Awareness Subscale)(Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
- Symptom Checklist-90 Revised (Depression Subscale)(Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
- Philadelphia Mindfulness Scale (Acceptance Subscale)(Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
- Patient Health Questionnaire (PHQ-9)(Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)