Condition category
Mental and Behavioural Disorders
Date applied
01/07/2008
Date assigned
07/08/2008
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Manfred E. Beutel

ORCID ID

Contact details

Clinic for Psychosomatic Medicine and Psychotherapy
University of Mainz
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany
-
manfred.beutel@unimedizin-mainz.de

Type

Scientific

Additional contact

Prof Elmar Brähler

ORCID ID

Contact details

Department for Medical Psychology and Medical Sociology
University Leipzig
Philipp-Rosenthal-Str. 55
Leipzig
04103
Germany
+49 (0)341 971 8800
elmar.braehler@medizin.uni-leipzig.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

107457 & 109379 (Mainz) and 107870 & 109381 (Leipzig)

Study information

Scientific title

Effectiveness of psychodynamic short-term psychotherapy of depression in patients with breast cancer

Acronym

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 overall trial end date was changed from 30/09/2010 to 31/12/2012.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant 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

Recruitment start date

01/10/2007

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University of Mainz
Mainz
D-55131
Germany

Trial participating centre

University of Leipzig
Leipzig
04103
Germany

Sponsor information

Organisation

German Cancer Aid (Deutsche Krebshilfe) (Germany)

Sponsor details

Buschstr. 32
Bonn
D-53004
Germany
-
deutsche@krebshilfe.de

Sponsor type

Research organisation

Website

http://www.krebshilfe.de

Funders

Funder type

Research organisation

Funder name

Deutsche Krebshilfe

Alternative name(s)

German Cancer Aid

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23217093
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24347520
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26163828

Publication citations

  1. Protocol

    Zwerenz R, Beutel ME, Imruck BH, Wiltink J, Haselbacher A, Ruckes C, Schmidberger H, Hoffmann G, Schmidt M, Köhler U, Langanke D, Kortmann RD, Kuhnt S, Weissflog G, Barthel Y, Leuteritz K, Brähler E, Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial., BMC Cancer, 2012, 12, 578, doi: 10.1186/1471-2407-12-578.

  2. Results

    Beutel ME, Weißflog G, Leuteritz K, Wiltink J, Haselbacher A, Ruckes C, Kuhnt S, Barthel Y, Imruck BH, Zwerenz R, Brähler E, Efficacy of short-term psychodynamic psychotherapy (STPP) with depressed breast cancer patients: results of a randomized controlled multicenter trial., Ann. Oncol., 2014, 25, 2, 378-384, doi: 10.1093/annonc/mdt526.

  3. Results

    Weißflog G, Brähler E, Leuteritz K, Barthel Y, Kuhnt S, Wiltink J, Zwerenz R, Beutel ME, Does psychodynamic short-term psychotherapy for depressed breast cancer patients also improve fatigue? Results from a randomized controlled trial, Breast Cancer Res Treat, 2015 .

Additional files

Editorial Notes