跳至主要内容
临床试验/NCT03972020
NCT03972020Unknown不适用

Mindful-life: a Randomized Clinical Trial to Evaluate the Efficacy of a Mindfulness Based Intervention as Compared to Cognitive Behavioral Therapy for Depressive Symptoms and Quality of Life in Patients With Breast Cancer

University of Turin, Italy0 个研究点目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
changes in depression symptoms

研究概览

简要总结

Breast cancer is the most common cancer pathology among women worldwide and represents a complex psychological challenge for those affected. Diagnosis and subsequent treatments can have a significant impact not only on the physical well-being of people, but also on their psychological well-being. Tumor-related distress is described as an "unpleasant emotional multifactorial experience of a psychological, social and / or spiritual nature that can interfere with the ability to effectively cope with cancer, physical symptoms and treatment" from the National Comprehensive Cancer Network.Studies have shown that from one third to half of breast cancer patients can experience psychological distress. The psychological distress, understood as symptoms of anxiety, depression and stress, is related to a lower quality of life, a lower compliance related to a lower efficacy of the treatments, a higher mortality and a higher risk of suicide, so much so that this discomfort it is recognized as the sixth vital sign in cancer treatment. Both the diagnosis of cancer and the treatments related to the disease, can lead to the alternation of depressive phases and in some cases even to the presence of major depression: it is estimated that the levels of depression reach thresholds that oscillate between 5 and 25% between women suffering from breast cancer.

In reference to what are the interventions aimed at reducing depressive symptomatology in patients with breast cancer, in this study we refer in particular to 2 treatments, of which several studies attest to their effectiveness: interventions based on Mindfulness (MBI) and interventions based on cognitive behavioral therapy (CBT).

Cognitive-behavioral therapy (CBT) is an empirically supported treatment for depression. Numerous studies have shown that CBT is both effective in treating acute depression and preventing subsequent relapses and relapses after the end of active treatment.

MBI-based interventions have been widely disseminated both at the clinical and research level as short, cost-effective interventions.

Several systematic reviews have shown the effectiveness of MBIs in improving anxiety and depressive symptoms, sleep, fatigue, disease adaptation and stress reduction, with coping and well-being improved in patients with chronic illnesses including also the oncological pathologies. In particular, a meta-analysis of studies conducted on women with breast cancer confirmed the effectiveness of MBI in reducing symptoms of anxiety, depression and stress, suggesting the importance of these treatments in improving the mental health of these women. In addition, studies have shown that the improvements achieved are stable even at long-term follow-up.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • breast cancer;
  • understanding of the Italian language;
  • interruption of all psychotropic drugs at least one month before treatment and maintenance of interruption throughout the study or maintenance at baseline level;
  • legal capacity to express consent to the processing;
  • completion of all treatments except hormone therapy or trastuzumab at least 1 month before;
  • score> of 13 and <of 30 at the BDI (Beck Depression Inventory (BDI);
  • the ability to use at least e-mail management applications.

排除标准

  • presence of serious psychological or psychiatric disorder, (eg severe major depressive disorder, psychotic disorder and bipolar disorder or abuse of active substances);
  • severe suicidal tendency;
  • presence of overt dementia;
  • previous participation in groups of Mindfulness Based Intervention and Cognitive Behavioral Therapy groups.

结局指标

主要结局

changes in depression symptoms

时间窗: week 0, week 8, week 20, week 44

Beck Depression Inventory (BDI)

changes in depression and anxiety symptoms

时间窗: week 0, week 8, week 20, week 44

Depression Anxiety Stress Scale

changes in HRV

时间窗: week 0, week 8, week 20, week 44

Heart Rate Variability evaluation during practice

次要结局

  • changes in brest cancer quality of life(week 0, week 8, week 20, week 44)
  • changes in fatigue(week 0, week 8, week 20, week 44)
  • changes in self compassion(week 0, week 8, week 20, week 44)
  • changes in sleep quality(week 0, week 8, week 20, week 44)
  • changes in attention and self awareness(week 0, week 8, week 20, week 44)
  • changes in trauma sypmtoms(week 0, week 8, week 20, week 44)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

luca ostacoli

Associate professor of clinical psychology

University of Turin, Italy

相似试验