Contact information
Type
Scientific
Primary contact
Prof Christoph Herrmann-Lingen
ORCID ID
Contact details
University of Göttingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
Göttingen
D-37075
Germany
+49 (0)551 39 67 07
cherrma@gwdg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZKSK-371
Study information
Scientific title
A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a randomised controlled trial (SPIRR-CAD)
Acronym
SPIRR-CAD
Study hypothesis
To determine the effects of a psychotherapy intervention on symptoms of depression in depressed patients with coronary artery disease.
Ethics approval
Ethics Committee of University of Göttingen, 25/10/2007, ref: 5/10/07
Study design
Randomised controlled multi-centre clinical trial with masked evaluation (observer)
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 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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2008
Overall trial end date
30/09/2013
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
569
Participant 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
Recruitment start date
01/11/2008
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Germany
Trial participating centre
University of Göttingen
Göttingen
D-37075
Germany
Sponsor information
Organisation
University of Göttingen (Germany)
Sponsor details
c/o Prof. Dr. Christoph Herrmann-Lingen
Department of Psychosomatic Medicine and Psychotherapy
von-Siebold-Str. 5
Göttingen
D-37075
Germany
+49 551 39 67 07
cherrma@gwdg.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Deutsche Forschungsgemeinschaft
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
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
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21911098
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27187851
Publication citations
-
Protocol
Albus C, Beutel ME, Deter HC, Fritzsche K, Hellmich M, Jordan J, Juenger J, Krauth C, Ladwig KH, Michal M, Mueck-Weymann M, Petrowski K, Pieske B, Ronel J, Soellner W, Waller C, Weber C, Herrmann-Lingen C, A stepwise psychotherapy intervention for reducing risk in coronary artery disease (SPIRR-CAD) - rationale and design of a multicenter, randomized trial in depressed patients with CAD., J Psychosom Res, 2011, 71, 4, 215-222, doi: 10.1016/j.jpsychores.2011.02.013.
-
Results
Herrmann-Lingen C, Beutel ME, Bosbach A, Deter HC, Fritzsche K, Hellmich M, Jordan J, Jünger J, Ladwig KH, Michal M, Petrowski K, Pieske B, Ronel J, Söllner W, Stöhr A, Weber C, de Zwaan M, Albus C; SPIRR-CAD Study Group, Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease: Results of an Observer-Blinded, Multicenter, Randomized Trial in Depressed Patients With Coronary Artery Disease, Psychosom Med, 2016.