Psychotherapy of depression in patients with breast cancer

ISRCTN	ISRCTN96793588
DOI	https://doi.org/10.1186/ISRCTN96793588
Secondary identifying numbers	107457 & 109379 (Mainz) and 107870 & 109381 (Leipzig)

Submission date: 01/07/2008
Registration date: 07/08/2008
Last edited: 17/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Manfred E. Beutel
Scientific

Clinic for Psychosomatic Medicine and Psychotherapy
University of Mainz
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany

Email	manfred.beutel@unimedizin-mainz.de

Prof Elmar Brähler
Scientific

Department for Medical Psychology and Medical Sociology
University Leipzig
Philipp-Rosenthal-Str. 55
Leipzig
04103
Germany

Phone	+49 (0)341 971 8800
Email	elmar.braehler@medizin.uni-leipzig.de

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effectiveness of psychodynamic short-term psychotherapy of depression in patients with breast cancer
Study objectives	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 overall trial end date was changed from 30/09/2010 to 31/12/2012.
Ethics approval(s)	Ethics Committee of the Landesärztekammer Rheinland Pfalz (Medical association of Rhineland-Palatinate), Mainz, 29/11/2006, ref: 837.90.06 (5478)
Health condition(s) or problem(s) studied	Depressive disorder in patients with breast cancer
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	01/10/2007
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	180
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Germany

Study participating centres

University of Mainz

Mainz
D-55131
Germany

University of Leipzig

Leipzig
04103
Germany

Sponsor information

German Cancer Aid (Deutsche Krebshilfe) (Germany)
Research organisation

Buschstr. 32
Bonn
D-53004
Germany

Email	deutsche@krebshilfe.de
Website	http://www.krebshilfe.de
"ROR"	https://ror.org/01wxdd722

Funders

Funder type

Research organisation

Deutsche Krebshilfe
Private sector organisation / Other non-profit organizations

Alternative name(s): Stiftung Deutsche Krebshilfe, German Cancer Aid
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/12/2012	Yes	No
Results article	results	01/02/2014	Yes	No
Results article	results	01/08/2015	Yes	No