Psychotherapy of depression in patients with breast cancer

Not Applicable

Completed

Conditions: Depressive disorder in patients with breast cancer
Mental and Behavioural Disorders
Reaction to severe stress and adjustment disorders

Registration Number: ISRCTN96793588

Lead Sponsor: German Cancer Aid (Deutsche Krebshilfe) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 180

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission of depression:<br>1. HADS: decrease of at least 2 points<br>2. SCID-I: no diagnosis of depressive disorder<br><br>Timepoints:<br>Screening = T0 = 0 months <br>Baseline = T1 = 0 months <br>End of treatment = T2 = ca. 6 months after baseline diagnsotics <br>Follow-up = T3 = ca. 12 months after baseline diagnostics

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of life.<br><br>Timepoints:<br>Baseline = T1 = 0 months <br>End of treatment = T2 = ca. 6 months after baseline diagnsotics <br>Follow-up = T3 = ca. 12 months after baseline diagnostics