Psychodynamic Motivation and Training Program

Study Overview
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Brief Summary
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The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.

Detailed Description
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Nonpharmacological secondary prevention of coronary heart disease is considered to be a safe and effective measure for reducing mortality substantially. Major targets are the improvement of physical activity and dietary habits, smoking cessation and stress reduction. Despite the effectiveness of life style changes, the compliance rate of patients is very low. To improve compliance with life style change programs psychotherapeutic interventions appear to have significant potential. Against this background our study aims to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) in addition to one session of advice in exercise training based on the results of spiroergometry (+EX) and usual cardiological care (TAU). PMT will be compared with +Ex and TAU. N = 90 patients with stable coronary artery disease class, low physical activity, class I to III angina pectoris will be randomly assigned to the three treatment conditions. The Primary efficacy endpoint is change in the anaerobic threshold from baseline to 6 month follow-up. The results of the study will 1) help to determine the effectiveness of a psychodynamic life style change programs for the secondary prevention of cardiovascular disease and 2) will help to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.

Official Title
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Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease

Conditions
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Coronary Heart Disease, Physical Activity

Intervention / Treatment
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* Behavioral: Psychodynamic Motivation and Training Program (PMT)
* Behavioral: Advice in Exercise Training (+Ex)
* Other: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable coronary heart disease with CCS functional classification of angina class I-III Low self rated physical activity Condition after percutaneous coronary intervention > 4 weeks until < 26 weeks or > 52 weeks after index percutaneous coronary intervention Residence < 50 km radius of Mainz If treatment with betablockers or ivabradine then stable > 4 weeks Exclusion Criteria: Acute coronary sydnrome or myocardial infarction < 8 weeks Coronary stenosis of the dominant vessel > 25% or high grade stenosis of the left coronary artery Heart failure with left ventricular ejection fraction < 40% NYHA III-IV Severe heart valve disorder Insulin dependent diabetes Orthopedic disorders or other disorders, which preclude regular physical activity Coronary artery bypass surgery < 6 months before index PCI Severe obesity (BMI ≥ 40) Need for systemic immunosuppression with cortisone or methotrexate Kidney failure with need for dialysis Intake of nitrates < 12 hours

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: Psychodynamic Motivation and Training Program (PMT)<br> | Behavioral: Psychodynamic Motivation and Training Program (PMT)<br>* The Psychodynamic Motivation and Training Program (PMT) is a psychodynamic stepped care approach. Depending on the individual needs PMT consists of 3 to 8 sessions of individual psychodynamic psychotherapy. If appropriate session 4 - 8 may be conducted by a nurse. PMT targets the mental and external barriers to improve physical activity by focusing on affects, interpersonal relations and maladaptive self- and other representations. PMT will be offered in addition to +Ex.<br>|
| Active Comparator: Advice in Exercise Training<br>One session of advice in exercise training based on the results of spiroergometry | Behavioral: Advice in Exercise Training (+Ex)<br>* Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.<br>|
| Other: Treatment as usual (TAU)<br>Usual care by family doctor and cardiologist | Other: Treatment as usual (TAU)<br>* Usual care by family doctor, cardiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in individual anaerobic threshold according to lactate kinetics during spiroergometry |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life according to the EQ-5D |  | 6 months | 
| Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire |  | 6 Months | 
| Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire |  | 6 months | 
| Change in endothelial function according to the flow mediated dilatation |  | 6 months | 
| Change in high density lipoprotein levels |  | 6 months | 
| Change in biomarkers of inflammation and oxidative burst |  | 6 months | 
| Change in fatigue according to the Maastricht Questionnaire |  | 6 months | 
| Change in illness perception | (Illness perception as measured with the Brief Illness Perception Questionnaire) | 6 months | 
| Change in maximal aerobic capacity (VO2 max) |  | 6 months | 
| Change in body mass index | (BMI kg/m²) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychodynamic psychotherapy, coronary heart disease, physical activity, secondary prevention