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

ISRCTN	ISRCTN76240576
DOI	https://doi.org/10.1186/ISRCTN76240576
Protocol serial number	ZKSK-371
Sponsor	University of Göttingen (Germany)
Funder	Deutsche Forschungsgemeinschaft

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

Primary study design	Interventional
Study design	Randomised controlled multi-centre clinical trial with masked evaluation (observer)
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

University of Göttingen

Göttingen
D-37075
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016		Yes	No
Results article	results	01/01/2017		Yes	No
Results article	results	01/02/2018		Yes	No
Results article	gender differences results	01/10/2018		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
Protocol article	protocol	01/10/2011		Yes	No
Other publications	secondary analysis	01/05/2018		Yes	No
Other publications	secondary analysis	04/02/2019		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.