Psychodynamic Motivation and Training Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

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.

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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.

Conditions

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Coronary Heart Disease Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Psychodynamic Motivation and Training Program (PMT)

Group Type EXPERIMENTAL

Psychodynamic Motivation and Training Program (PMT)

Intervention Type BEHAVIORAL

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.

Advice in Exercise Training

One session of advice in exercise training based on the results of spiroergometry

Group Type ACTIVE_COMPARATOR

Advice in Exercise Training (+Ex)

Intervention Type BEHAVIORAL

Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.

Treatment as usual (TAU)

Usual care by family doctor and cardiologist

Group Type OTHER

Treatment as usual (TAU)

Intervention Type OTHER

Usual care by family doctor, cardiologist

Interventions

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Psychodynamic Motivation and Training Program (PMT)

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.

Intervention Type BEHAVIORAL

Advice in Exercise Training (+Ex)

Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

Usual care by family doctor, cardiologist

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No