The Efficacy of a Mindfulness Based Intervention for Depressive Symptoms in Patients With Multiple Sclerosis and Their Caregivers. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- depression score
研究概览
简要总结
Multiple Sclerosis has a great impact on psychological functioning of patients and can be associated with various psychological disorders and symptoms. The most prevalent one is depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a relatively brief and cost-effective program that has been studied in patients with several diseases.
Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on correlated symptoms of MS patients and their caregivers.
Methods. The study design is a randomized controlled clinical trial. The subjects of the study are 88 patients with MS and depressive symptoms that will be pre-screened from among a catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88 patients will subsequently be randomized into two groups (44 in the experimental group and 44 in the active control group). The psychological assessment, independent and blind to treatment, will be performed with the same timing and tools: at baseline (T0), after treatment (T1), and 6 months after the end of the group intervention (T2). The assessment will encompass the administration of the clinical interview and other self-report questionnaires.
The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better tailor it on the needs of people with MS suffering from depressive symptoms. The active control group is designed to control for the non-specific elements of the MBI treatment and will follow the same structure as the MBI. It will be based on a psycho-educational framework and will include relaxation techniques.
Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2 that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the improvement of FAMS scores for the six primary aspects of QoL.
详细描述
Multiple Sclerosis (MS) can be associated with various psychological disorders and symptoms. Depression is present in about 15-47% of MS patients, and it is estimated to be three times greater than the general population.
Anxiety and depression are closely associated, both independently and in interaction, with fatigue. Mohr et al. (2003) have shown that improvements of depressive symptoms are closely associated with a decrease in the severity of fatigue. These symptoms represents the most disabling symptoms that have heavy psychosocial consequences for patients, for example affecting relationships, leisure activities and employment. Given also the young age at which MS occurs it is important that these symptoms be adequately recognized and treated to prevent their chronicity.
A recent study on psychological treatment of depressive symptoms in patients with medical disorders stated that treating comorbid depression should be one of the priorities in medical care settings. Feinstein (2011) highlighted that treatments for depression in public health care services may also be adjusted according to the availability of resources and access to them. Thereby it is essential to establish brief and cost-effective interventions to reduce depression symptoms and the psychological burden and to improve the Quality of Life (QoL) of these patients.
Mindfulness-based interventions have been proven effective in improving depressive symptoms and in enhancing QoL in many different chronic conditions and recently also in MS patients.
Mindfulness could be defined as a nonjudgmental awareness and acceptance of one's moment-to-moment experience. As described by Bishop et al. (2004), mindfulness consist of two main component: the self- regulation of attention and a particular orientation toward the experience. Self-regulation of attention concern the nonjudgmental observation and awareness of physical sensations, affective states and thoughts as they arise. Orientation to experience refers to the attitude of acceptance and curiosity toward one's experience. Mindfulness has an effect on the distressing tendencies to escape from or to over-engage with one's disturbing feelings and thoughts.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite diagnosis of MS (Mc Donald Criteria) evaluated by a neurologist at least six months prior the beginning of the study;
- •relapsing-remitting and secondary progressive disease;
- •age 18-65 years old;
- •clinically inactive phase of the disease ;
- •a score >13 on the Beck Depression Inventory-II (according to Goldman Consensus Group, 2005);
- •an Expanded Disability Status Scale (EDSS) score of =6;
- •fluent Italian speaker;
- •legal capacity to consent to the treatment;
- •willingness to abstain from or to suspend all concomitant psychological treatment;
- •suspension of all psychotropic medications at least one month before the treatment or maintenance at baseline level throughout the study.
排除标准
- •current severe Major Depressive Disorder;
- •severe suicidality, including ideation, plan, and intent;
- •current serious psychological and psychiatric disorders, including psychotic disorders, bipolar disorders, active substance abuse (as assessed by the SCID);
- •presence of overt dementia;
- •corticosteroid treatment during the previous 30 days;
- •other serious medical disorders in addition to MS;
- •pregnancy.
研究组 & 干预措施
Mindulness Based Intervention
intervention with group-based Mindfulness Based Intervention
干预措施: Mindfulness (Behavioral)
Active Control
intervention with group-based Psychoeducation and Relaxation
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
depression score
时间窗: 6 months follow-up
the proportion of participants at T2 that do not have a BDI-II score greater than 13
次要结局
- QoL(6 months follow-up)
- mood disorder(6 months follow-up)
研究者
luca ostacoli
Dr.
University of Turin, Italy