To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
20 mg tablet one or twice daily for 12 weeks
One session weekly for 12 weeks
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, Spain
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
The BDI is a validated, self-reported instrument assessing the severity of depression. Scoring range 0-9 indicates minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Time frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Change from Baseline in quality of life on the European Quality of Life Scale Five Dimensions and Three Levels (EQ-5D-3L) at week 12.
The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.
Time frame: Baseline and week 12.
Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
Number of days off work.
Time frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Age of patients.
Measured in years.
Time frame: Baseline.
Marital status.
Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.
Time frame: Baseline.
Cancer treatment received.
Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.
Time frame: Baseline.
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Breast cancer stage.
Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.
Time frame: Baseline.
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.
Time frame: fMRI at baseline.
Change from baseline in emotional processing on the Dot-Probe Task (DPT).
The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.
Time frame: DPT at baseline and week 12.
Cost-effectiveness ratio differences between pharmacological treatment with citalopram and psychological treatment in patients in our environment with breast cancer (BC) and major depression (MD).
Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).
Time frame: At week 12.
Number and severity of secondary side effects related to the consumption of pharmacological treatment with citalopram according to the side effects rating scale Udvalg für Kliniske Undersogelser (UKU).
The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).
Time frame: At week 3, 6, 9 and 12.