Mindful-life: Mindfulness Based Intervention vs Cognitive Behavioral Therapy in Patients With Breast Cancer

June 30, 2020 updated by: luca ostacoli, University of Turin, Italy

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Based Intervention
8 group sessions lasting 2.5 hours each, on a weekly basis.
Behavioral: Mindfulness Based Intervention

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.

Other Names:
  • MBI; BAM
Active Comparator: Cognitive Behavioral Therapy
8 group sessions lasting 2.5 hours each, on a weekly basis.
Behavioral: Cognitive Behavioral Therapy
Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
Other Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in depression symptoms
Time Frame: week 0, week 8, week 20, week 44
Beck Depression Inventory (BDI)
week 0, week 8, week 20, week 44
changes in depression and anxiety symptoms
Time Frame: week 0, week 8, week 20, week 44
Depression Anxiety Stress Scale
week 0, week 8, week 20, week 44
changes in HRV
Time Frame: week 0, week 8, week 20, week 44
Heart Rate Variability evaluation during practice
week 0, week 8, week 20, week 44

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in brest cancer quality of life
Time Frame: week 0, week 8, week 20, week 44
Functional Assessment of Cancer Therapy - Breast (FACT-B)
week 0, week 8, week 20, week 44
changes in fatigue
Time Frame: week 0, week 8, week 20, week 44
Additional Concern Subscale of the Functional Assessment of Illness Therapy - Fatigue subscale (FACIT-F)
week 0, week 8, week 20, week 44
changes in self compassion
Time Frame: week 0, week 8, week 20, week 44
Self-Compassion Scale-forma breve (SCS-SF)
week 0, week 8, week 20, week 44
changes in sleep quality
Time Frame: week 0, week 8, week 20, week 44
Pittsburgh Sleep Quality Index (PSQI)
week 0, week 8, week 20, week 44
changes in attention and self awareness
Time Frame: week 0, week 8, week 20, week 44
Mindfulness Awareness Attention Scale (MAAS)
week 0, week 8, week 20, week 44
changes in trauma sypmtoms
Time Frame: week 0, week 8, week 20, week 44
Impact of Event Scale - Revised (IES-R)
week 0, week 8, week 20, week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OstacoliMIND&BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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