Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
Primary Purpose
Breast Cancer, Depressive Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, mindfulness based intervention, cognitive behavioral therapy, depressive symptoms
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Based Intervention
Cognitive Behavioral Therapy
Arm Description
8 group sessions lasting 2.5 hours each, on a weekly basis.
8 group sessions lasting 2.5 hours each, on a weekly basis.
Outcomes
Primary Outcome Measures
changes in depression symptoms
Beck Depression Inventory (BDI)
changes in depression and anxiety symptoms
Depression Anxiety Stress Scale
changes in HRV
Heart Rate Variability evaluation during practice
Secondary Outcome Measures
changes in brest cancer quality of life
Functional Assessment of Cancer Therapy - Breast (FACT-B)
changes in fatigue
Additional Concern Subscale of the Functional Assessment of Illness Therapy - Fatigue subscale (FACIT-F)
changes in self compassion
Self-Compassion Scale-forma breve (SCS-SF)
changes in sleep quality
Pittsburgh Sleep Quality Index (PSQI)
changes in attention and self awareness
Mindfulness Awareness Attention Scale (MAAS)
changes in trauma sypmtoms
Impact of Event Scale - Revised (IES-R)
Full Information
NCT ID
NCT03972020
First Posted
February 11, 2019
Last Updated
June 30, 2020
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT03972020
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Depressive Symptoms
Keywords
breast cancer, mindfulness based intervention, cognitive behavioral therapy, depressive symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Intervention
Arm Type
Experimental
Arm Description
8 group sessions lasting 2.5 hours each, on a weekly basis.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
8 group sessions lasting 2.5 hours each, on a weekly basis.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Intervention
Other Intervention Name(s)
MBI; BAM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
Primary Outcome Measure Information:
Title
changes in depression symptoms
Description
Beck Depression Inventory (BDI)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in depression and anxiety symptoms
Description
Depression Anxiety Stress Scale
Time Frame
week 0, week 8, week 20, week 44
Title
changes in HRV
Description
Heart Rate Variability evaluation during practice
Time Frame
week 0, week 8, week 20, week 44
Secondary Outcome Measure Information:
Title
changes in brest cancer quality of life
Description
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in fatigue
Description
Additional Concern Subscale of the Functional Assessment of Illness Therapy - Fatigue subscale (FACIT-F)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in self compassion
Description
Self-Compassion Scale-forma breve (SCS-SF)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in attention and self awareness
Description
Mindfulness Awareness Attention Scale (MAAS)
Time Frame
week 0, week 8, week 20, week 44
Title
changes in trauma sypmtoms
Description
Impact of Event Scale - Revised (IES-R)
Time Frame
week 0, week 8, week 20, week 44
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ostacoli, Associate Prof.
Phone
3335613155
Email
luca.ostacoli@unito.it
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Malandrone, research ass.
Phone
3335613155
Email
francesca.malandrone@unito.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer
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