Clinical trial NCT03972020: Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Depressive Symptoms
Keywords: breast cancer
mindfulness based intervention
cognitive behavioral therapy
depressive symptoms
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: changes in depression symptoms
timeFrame: week 0, week 8, week 20, week 44
measure: changes in depression and anxiety symptoms
timeFrame: week 0, week 8, week 20, week 44
measure: changes in HRV
timeFrame: week 0, week 8, week 20, week 44
Secondary outcomes:
measure: changes in brest cancer quality of life
timeFrame: week 0, week 8, week 20, week 44
measure: changes in fatigue
timeFrame: week 0, week 8, week 20, week 44
measure: changes in self compassion
timeFrame: week 0, week 8, week 20, week 44
measure: changes in sleep quality
timeFrame: week 0, week 8, week 20, week 44
measure: changes in attention and self awareness
timeFrame: week 0, week 8, week 20, week 44
measure: changes in trauma sypmtoms
timeFrame: week 0, week 8, week 20, week 44
Other outcomes:
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