An interventional study of Mindfulness Based Intervention and Cognitive Behavioral Therapy in Breast Cancer and Depressive Symptoms, sponsored by University of Turin, Italy. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by University of Turin, Italy · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
8 group sessions lasting 2.5 hours each, on a weekly basis.
Behavioral: Mindfulness Based Intervention
8 group sessions lasting 2.5 hours each, on a weekly basis.
Behavioral: Cognitive Behavioral Therapy
The MBI used in this study is called body-affective mindfulness (BAM); BAM is based on: (1) awareness practices such as body scan, breath meditation, walking meditation and yoga exercises; (2) mindfulness in relationship practices such as loving kindness, enriching listening to nature and persons and self-compassion; (3) sensorimotor psychotherapy Sensorimotor psychotherapy emphasizes the use of somatic resources to attain and sustain a mindful disposition and integrates the concept of a stress response with the concept of a "window of tolerance" in order to maximize the clinical utility of the intervention and tailor it to breast cancer patients.
Also known as: MBI; BAM
Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
Also known as: CBT
changes in depression symptoms
Beck Depression Inventory (BDI)
Time frame: week 0, week 8, week 20, week 44
changes in depression and anxiety symptoms
Depression Anxiety Stress Scale
Time frame: week 0, week 8, week 20, week 44
changes in HRV
Heart Rate Variability evaluation during practice
Time frame: week 0, week 8, week 20, week 44
changes in brest cancer quality of life
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: week 0, week 8, week 20, week 44
changes in fatigue
Additional Concern Subscale of the Functional Assessment of Illness Therapy - Fatigue subscale (FACIT-F)
Time frame: week 0, week 8, week 20, week 44
changes in self compassion
Self-Compassion Scale-forma breve (SCS-SF)
Time frame: week 0, week 8, week 20, week 44
changes in sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 0, week 8, week 20, week 44
changes in attention and self awareness
Mindfulness Awareness Attention Scale (MAAS)
Time frame: week 0, week 8, week 20, week 44
changes in trauma sypmtoms
Impact of Event Scale - Revised (IES-R)
Time frame: week 0, week 8, week 20, week 44
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Turin, Italy