Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2022
Shorter than P25 for not_applicable breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 2, 2020
June 1, 2020
9 months
February 11, 2019
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
changes in depression symptoms
Beck Depression Inventory (BDI)
week 0, week 8, week 20, week 44
changes in depression and anxiety symptoms
Depression Anxiety Stress Scale
week 0, week 8, week 20, week 44
changes in HRV
Heart Rate Variability evaluation during practice
week 0, week 8, week 20, week 44
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Mindfulness Based Intervention
EXPERIMENTAL8 group sessions lasting 2.5 hours each, on a weekly basis.
Cognitive Behavioral Therapy
ACTIVE COMPARATOR8 group sessions lasting 2.5 hours each, on a weekly basis.
Interventions
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.
Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of clinical psychology
Study Record Dates
First Submitted
February 11, 2019
First Posted
June 3, 2019
Study Start
January 1, 2022
Primary Completion
September 30, 2022
Study Completion
December 31, 2022
Last Updated
July 2, 2020
Record last verified: 2020-06