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
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Christian Albus1, Manfred E Beutel, Hans-Christian Deter
1Dept. of Psychosomatics and Psychotherapy, University of Cologne, Germany. christian.albus@uk-koeln.de
Insights
This study investigated a stepwise psychotherapy for coronary artery disease (CAD) patients with depression and Type D personality. The approach aims to improve depressive symptoms and quality of life in cardiac patients.
Area of Science:
- Cardiology
- Psychiatry
- Psychotherapy Research
Background:
- Depressive symptoms significantly impact quality of life, health behaviors, and prognosis in coronary artery disease (CAD) patients.
- Previous psychotherapy trials for depressed CAD patients showed limited effects on depression and no impact on cardiac events.
- The Type D pattern, characterized by negative affectivity and social inhibition, is common in CAD patients.
Purpose of the Study:
- To evaluate the efficacy of a stepwise psychotherapy intervention for treating depressive symptoms and the Type D pattern in patients with CAD.
- To assess the impact of the intervention on cardiac events, remission of depressive disorder, and health-related quality of life.
Main Methods:
- A multicentre randomized controlled trial involving 569 CAD patients with depression (Hospital Anxiety and Depression Scale [HADS] score ≥ 8).
- Patients were randomized (1:1) to receive either a stepwise psychotherapy intervention or a single psychosocial counseling session (control group).
- The intervention group received initial supportive individual psychotherapy, followed by combined psychodynamic and cognitive-behavioral group therapy for persistent symptoms.
Main Results:
- The primary efficacy variable is the change in HADS depression scores from baseline to 18 months.
- Secondary endpoints include cardiac events, remission of depressive disorder and Type D pattern, quality of life, cardiovascular risk profile, and health care utilization up to 24 months.
Conclusions:
- The study aims to provide evidence for an effective psychotherapy approach for comorbid depression and Type D personality in CAD patients.
- Findings are expected to inform clinical practice and improve outcomes for this vulnerable patient population.
Objective:
Depressive symptoms are highly relevant for the quality of life, health behavior, and prognosis in patients with coronary artery disease (CAD). However, previous psychotherapy trials in depressed CAD patients produced small to moderate effects on depression, and null effects on cardiac events. In this multicentre psychotherapy trial, symptoms of depression are treated together with the Type D pattern (negative affectivity and social inhibition) in a stepwise approach.
Methods:
Men and women (N=569, age 18-75 years) with any manifestation of CAD and depression scores ≥ 8 on the Hospital Anxiety and Depression Scale (HADS), will be randomized (allocation ratio 1:1) into the intervention or control group. Patients with severe heart failure, acutely life-threatening conditions, chronic inflammatory disease, severe depressive episodes or other severe mental illness are excluded. Both groups receive usual medical care. Patients in the intervention group receive three initial sessions of supportive individual psychotherapy. After re-evaluation of depression (weeks 4-8), patients with persisting symptoms receive an additional 25 sessions of combined psychodynamic and cognitive-behavioral group therapy. The control group receives one psychosocial counseling session. Primary efficacy variable is the change of depressive symptoms (HADS) from baseline to 18 months. Secondary endpoints include cardiac events, remission of depressive disorder (SCID) and Type D pattern, health-related quality of life, cardiovascular risk profile, neuroendocrine and immunological activation, heart rate variability, and health care utilization, up to 24 months of follow-up (ISRCTN: 76240576; NCT00705965). Funded by the German Research Foundation.
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