Depressive disorder in patients with breast cancer Mental and Behavioural Disorders Reaction to severe stress and adjustment disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Breast cancer, curative treatment intent 2. Elevated score (greater than or equal to 8) of depression on the Hospital Anxiety and Depression Scale (HADS) and diagnosis of depression (International Classification of Diseases [ICD-10] diagnoses depressive episode [F32], recurrent depressive disorder [F33], dysthymia [F34.1], adjustment disorders [F43.21]) according to the Structured Interview for Diagnostic and Statistical Manual of Mental Disorders - fourth edition (SCID-I-DSMIV) 3. Aged 18 - 70 years, females
Exclusion criteria
Exclusion criteria: 1. Severe medical conditions (metastases, cognitive impairments) 2. Severe psychiatric disorders (psychotic disorder, risk of self-harm, acute substance-related disorder, personality disorders except for cluster C, organic mental disorder) 3. Concurrent psychotherapeutic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission of depression: 1. HADS: decrease of at least 2 points 2. SCID-I: no diagnosis of depressive disorder Timepoints: Screening = T0 = 0 months Baseline = T1 = 0 months End of treatment = T2 = ca. 6 months after baseline diagnsotics Follow-up = T3 = ca. 12 months after baseline diagnostics | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of quality of life. Timepoints: Baseline = T1 = 0 months End of treatment = T2 = ca. 6 months after baseline diagnsotics Follow-up = T3 = ca. 12 months after baseline diagnostics | — |
Countries
Germany