Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.

Official Title
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A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

Conditions
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Depression, Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Psychotherapy
* Behavioral: Information session
* Other: Usual cardiological care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with coronary artery disease German speaking men and women Recent coronary angiogram (<= 3 months old) Depression score (HADS-D) >= 8 Written informed consent Exclusion Criteria: Severe heart failure Other acutely life- threatening conditions Severe chronic inflammatory disease Current suicidal tendency Severe depressive episode Other severe mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care. | Behavioral: Psychotherapy<br>* Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.<br>* Other names: Stepwise manualized psychotherapy;Other: Usual cardiological care<br>* Usual cardiological care<br>|
| Active Comparator: 2<br>Usual cardiological care including one information session. | Behavioral: Information session<br>* One information session about living with heart disease.<br>Other: Usual cardiological care<br>* Usual cardiological care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to 18 months in depressive symptoms (HADS-D) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D) |  | 18 months | 
| Health-related quality of life (SF36, EuroQuol-5D) |  | 18 months | 
| cardiovascular risk profile |  | 18 months | 
| neuroendocrine and immunological activation |  | 18 months | 
| coagulation |  | 18 months | 
| heart rate variability |  | 18 months | 
| cardiac events |  | 18 months | 
| health care utilisation and costs |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, depression, psychotherapy, randomized controlled trial