Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline on the combined Quick Inventory of Depressive Symptomatology-clinician rated and the Hamilton Rating Scale for Depression (QIDS-C16/HRDS17), at week 8.
研究概览
简要总结
The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a psychological and neurobiological level. For this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. Moreover this study involves optional fMRI scans of the brain and blood measures before and after the intervention.
Main hypotheses:
- The MBCT training will be a feasible intervention in patients with chronic pain and co-morbid depression as defined by no occurrence of serious adverse events related to the intervention and a retention rate of more than 70% in the subjects assigned to the MBCT arm.
- Patients who have completed the MBCT training will demonstrate a significant decrease in depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology - Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17) (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure), compared to the control group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of Chronic Pain, which has persisted for at least 3 months.
- •Meets criteria of Major Depressive Disorder, Dysthymic Disorder or Depressive disorder NOS as defined by DSM-IV criteria.
- •Have a minimum score of depressive symptoms of > 10 as rated on the QIDS-C, administered during the screen.
- •Able to provide written informed consent.
- •Adults 18 years or older
- •English-language literacy.
排除标准
- •Serious suicide or homicide risk, as assessed by evaluating clinician.
- •Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease for which hospitalization is likely to be required within the next half year.
- •The following DSM-IV disorders: any bipolar disorder (current or past), current psychotic symptoms, or a primary psychotic disorder (current or past). Entry of patients with anxiety disorder will be permitted if the depressive disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
- •Active diagnosis of substance abuse or dependence disorders within the last 3 months.
结局指标
主要结局
Change from Baseline on the combined Quick Inventory of Depressive Symptomatology-clinician rated and the Hamilton Rating Scale for Depression (QIDS-C16/HRDS17), at week 8.
时间窗: week 8
次要结局
- Response according to the Beck Anxiety Inventory, 21 items (BAI).(Baseline, week 8, 6 months, 12 months)
- Response according to Short Form Health Survey, 36 items (SF-36).(Baseline, week 8, 6 months, 12 months)
- Response according to Brief Pain Inventory (BPI-sf).(Baseline, week 4, week 8, 6 months, 12 months)
研究者
Heidi Ashih
Principal Investigator, Clinical Instructor
Massachusetts General Hospital