Condition category
Mental and Behavioural Disorders
Date applied
26/02/2008
Date assigned
27/03/2008
Last edited
19/05/2016
Prospective/Retrospective
Prospectively 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 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

http://www.med.uni-goettingen.de

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

19/05/2016: Publication reference added. 24/01/2011: the overall trial start date was changed from 01/10/2008 to 01/11/2008.