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Psychotherapy of depression in patients with breast cancer
ISRCTN ISRCTN96793588
DOI 10.1186/ISRCTN96793588
ClinicalTrials.gov identifier
EudraCT number
Public title Psychotherapy of depression in patients with breast cancer
Scientific title Effectiveness of psychodynamic short-term psychotherapy of depression in patients with breast cancer
Acronym N/A
Serial number at source 107457 & 109379 (Mainz) and 107870 & 109381 (Leipzig)
Study hypothesis In this study we evaluate a manualised supportive-expressive psychodynamic short-term psychotherapy for patients with breast-cancer, with hypotheses as follows:
1. The probability of remission of the depression is higher in breast cancer patients treated by psychodynamic short-term psychotherapy than in the 'treatment as usual' control group
2. Six months after the end of treatment a lower rate of depression and a higher quality of life exists among the 'psychotherapy group' compared to the 'treatment as usual group'

On 31/08/2012 the anticipated end date of this trial was changed from 30/09/2010 to 31/12/2012.
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of the Landesärztekammer Rheinland Pfalz (Medical association of Rhineland-Palatinate), Mainz, 29/11/2006, ref: 837.90.06 (5478)
Study design Multicentre randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Depressive disorder in patients with breast cancer
Participants - 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
Participants - 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
Anticipated start date 01/10/2007
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions Because this is a multicentre study there are two study centres (University of Mainz and University of Leipzig). Each study centre inserts half of the targeted number of patients (N = 90 Mainz and N = 90 Leipzig) within an identical study protocol:

Manualised short-term psychotherapy for patients with breast cancer (based on 'Supportive-Expressive Psychotherapy (SET)' versus treatment as usual (TAU). Short-term psychotherapy will consist of 25 sessions; each session 50 minutes long, frequency one session/week for sessions 1 - 18 and one session/two weeks for sessions 19 and 20.

Follow up will be 6 months after finishing SET in the intervention group and approximately 6 months after baseline diagnostics in the control group.

Principal Investigator of the Leipzig site:
Professor E. Brähler
Department for Medical Psychology and Medical Sociology,
University Leipzig Philipp-Rosenthal-Str. 55
04103 Leipzig
Tel. (00) +49 341 9718800
Fax (00) +49 341 9718809
Email: elmar.braehler@medizin.uni-leipzig.de
Website: http://medpsy.uniklinikum-leipzig.de/
Primary outcome measure(s) 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 outcome measure(s) 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
Sources of funding German Cancer Aid (Deutsche Krebshilfe) (Germany) - support programme 'Psychosocial Oncology' (ref: 107457)
Trial website
Publications 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23217093
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24347520
Contact name Prof  Manfred E.  Beutel
  Address Clinic for Psychosomatic Medicine and Psychotherapy
University of Mainz
Untere Zahlbacher Str. 8
  City/town Mainz
  Zip/Postcode D-55131
  Country Germany
  Email manfred.beutel@unimedizin-mainz.de
Sponsor German Cancer Aid (Deutsche Krebshilfe) (Germany)
  Address Buschstr. 32
  City/town Bonn
  Zip/Postcode D-53004
  Country Germany
  Email deutsche@krebshilfe.de
  Sponsor website: http://www.krebshilfe.de
Date applied 01/07/2008
Last edited 03/07/2014
Date ISRCTN assigned 07/08/2008
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