Effects of a psychotherapy intervention in depressed patients with coronary artery disease

ISRCTN ISRCTN76240576
DOI https://doi.org/10.1186/ISRCTN76240576
Secondary identifying numbers ZKSK-371
Submission date
26/02/2008
Registration date
27/03/2008
Last edited
12/11/2021
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 Christoph Herrmann-Lingen
Scientific

University of Göttingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
Göttingen
D-37075
Germany

Phone +49 (0)551 39 67 07
Email cherrma@gwdg.de

Study information

Study designRandomised controlled multi-centre clinical trial with masked evaluation (observer)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a randomised controlled trial (SPIRR-CAD)
Study acronymSPIRR-CAD
Study objectivesTo determine the effects of a psychotherapy intervention on symptoms of depression in depressed patients with coronary artery disease.
Ethics approval(s)Ethics Committee of University of Göttingen, 25/10/2007, ref: 5/10/07
Health condition(s) or problem(s) studiedDepressive symptoms in patients with coronary artery disease
InterventionExperimental intervention: Stepwise, manualised individual and group psychotherapy in addition to usual cardiological care. Patients randomised in the intervention group receive 3 sessions of individual psychotherapy (50 minutes per session, 1 session per week). Only those patients with persisting symptoms of depression receive additional 25 sessions of group psychotherapy (90 minutes per session) over 10 months (first 20 sessions on a weekly basis, then 5 sessions once a month).

Control intervention: Usual cardiological care including one psychosocial information session
Intervention typeOther
Primary outcome measureAmended as of 24/01/2011:
Changes from baseline to 18 months in depressive symptoms (HADS-D)

Initial information at time of registration:
Changes from baseline to year 1 in depressive symptoms (HADS-D)
Secondary outcome measuresAmended as of 24/01/2011:
The following will be monitored up to 24 months:
1. Remission of depressive disorder (Structured Clinical Interview [SCID]) at baseline and 18 months
2. Type D pattern, assessed by a self rating questionnaire (DS-14) at baseline, 1, 6, 12, 18 and 24 months
3. Health-related quality of life, evaluated by the self rating questionnaires the 36-item Short Form health survey (SF-36) and EuroQuol-5D at baseline, 6, 12, 18 and 24 months
4. Cardiovascular risk profile
5. Neuroendocrine and immunological activation
6. Coagulation
7. Heart rate variability
8. Cardiac events
9. Health care utilisation and costs

Initial information at time of registration:
The following will be monitored up to 24 months:
1. Remission of depressive disorder (Structured Clinical Interview [SCID]) at baseline and 12 months
2. Type D pattern, assessed by a self rating questionnaire (DS-14) at baseline, 1, 6, 12, and 24 months
3. Health-related quality of life, evaluated by the self rating questionnaires the 36-item Short Form health survey (SF-36) and EuroQuol-5D at baseline, 6, 12, and 24 months
4. Cardiovascular risk profile
5. Neuroendocrine and immunological activation
6. Coagulation
7. Heart rate variability
8. Cardiac events
9. Health care utilisation and costs
Overall study start date01/11/2008
Completion date30/09/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants569
Total final enrolment570
Key inclusion criteriaAmended as of 24/01/2011:
1. Gender: both
2. Minimum age: 18, maximum age: 75
3. Patients with any manifestation of coronary heart disease with recent (less than 3 months old) coronary angiograms and elevated questionnaire scores for depression (Hospital Anxiety and Depression Scale [HADS] depression subscale greater than or equal to 8)

Initial information at time of registration:
1. Gender: both
2. Minimum age: 18, maximum age: 75
3. Patients hospitalised for any manifestation of coronary heart disease with recent (less than 3 months old) coronary angiograms and elevated questionnaire scores for depression (Hospital Anxiety and Depression Scale [HADS] depression subscale greater than or equal to 8)
Key exclusion criteria1. Severe heart failure or other acutely life-threatening conditions
2. Severe chronic inflammatory disease
3. Current suicidal tendency
4. Severe depressive episode or other severe mental illness
Date of first enrolment01/11/2008
Date of final enrolment30/09/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Göttingen
Göttingen
D-37075
Germany

Sponsor information

University of Göttingen (Germany)
University/education

c/o Prof. Dr. Christoph Herrmann-Lingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
Göttingen
D-37075
Germany

Phone +49 (0)551 39 67 07
Email cherrma@gwdg.de
Website http://www.med.uni-goettingen.de
ROR logo "ROR" https://ror.org/01y9bpm73

Funders

Funder type

Government

Deutsche Forschungsgemeinschaft
Government organisation / National government
Alternative name(s)
German Research Association, German Research Foundation, DFG
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/10/2011 Yes No
Results article results 01/07/2016 Yes No
Results article results 01/01/2017 Yes No
Results article results 01/02/2018 Yes No
Other publications secondary analysis 01/05/2018 Yes No
Results article gender differences results 01/10/2018 Yes No
Other publications secondary analysis 04/02/2019 Yes No
Results article results 01/08/2019 05/08/2019 Yes No
Results article Secondary analysis in participants with depression 28/10/2021 12/11/2021 Yes No

Editorial Notes

12/11/2021: Publication reference added.
05/08/2019: Publication reference and total final enrolment added.
06/02/2019: Publication reference added.
10/09/2018: Publication reference added.
03/04/2018: Publication reference added.
31/01/2018: Publication reference added.
30/10/2017: Publication reference added.
19/05/2016: Publication reference added.
24/01/2011: The overall trial start date was changed from 01/10/2008 to 01/11/2008.