Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
- Conditions
- Breast CancerMajor Depressive Episode
- Interventions
- Behavioral: Psychotherapy
- Registration Number
- NCT05063604
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 40
- Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).
- Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.
- Informed Consent Form Signature
- Women who are pregnant or breastfeeding.
- Suicide risk.
- Metastatic brain disease.
- Personal History of oncological disease.
- Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
- Personal History of organic brain disorder, substance abuse/dependence.
- Personal History of psychotic disorder, bipolar disorder and/or mental retardation.
- Contraindications of citalopram treatment.
- Taking antidepressants after the breast cancer diagnosis.
- Psychotherapy treatment after breast cancer diagnosis .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychotherapy Psychotherapy Participants received one psychotherapy session weekly for 12 weeks. Citalopram 20-40 mg Citalopram Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12. Every three weeks from baseline to the end of the study at week 12 (5 assessments in total). 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.
- Secondary Outcome Measures
Name Time Method Cancer treatment received. Baseline. Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.
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). At week 3, 6, 9 and 12. 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).
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. Baseline and 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.
Change from Baseline in social-labor adaptation measured by number of days off work at week 12. Every three weeks from baseline to the end of the study at week 12 (5 assessments in total). Number of days off work.
Marital status. Baseline. Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.
Breast cancer stage. Baseline. 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.
Age of patients. Baseline. Measured in years.
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI). fMRI at baseline. 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.
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). At week 12. 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).
Change from baseline in emotional processing on the Dot-Probe Task (DPT). DPT at baseline and week 12. 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.
Trial Locations
- Locations (1)
Catalan Institute of Oncology
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain