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

A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a randomised controlled trial (SPIRR-CAD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76240576
Enrollment
569
Registered
2008-03-27
Start date
2008-11-01
Completion date
Unknown
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive symptoms in patients with coronary artery disease Mental and Behavioural Disorders Depression

Interventions

Experimental intervention: Stepwise, manualised individual and group psychotherapy in addition to usual cardiological care. Patients randomised in the intervention group receive 3 sessions of individu

Sponsors

University of Göttingen (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026