Effects of a psychotherapy intervention in depressed patients with coronary artery disease
ISRCTN | ISRCTN76240576 |
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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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
---|---|
cherrma@gwdg.de |
Study information
Study design | Randomised controlled multi-centre clinical trial with masked evaluation (observer) |
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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 to request a patient information sheet |
Scientific title | A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a randomised controlled trial (SPIRR-CAD) |
Study acronym | SPIRR-CAD |
Study objectives | To 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) studied | Depressive symptoms in patients with coronary artery disease |
Intervention | Experimental 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 type | Other |
Primary outcome measure | Amended 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 measures | Amended 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 date | 01/11/2008 |
Completion date | 30/09/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 569 |
Total final enrolment | 570 |
Key inclusion criteria | Amended 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 criteria | 1. 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 enrolment | 01/11/2008 |
Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
D-37075
Germany
Sponsor information
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 |
---|---|
cherrma@gwdg.de | |
Website | http://www.med.uni-goettingen.de |
https://ror.org/01y9bpm73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
Intention to publish date | |
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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 | Not 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.