Psychodynamic Motivation and Training Program (PMT)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Psychodynamic Motivation and Training Program (PMT); Behavioral: Advice in Exercise Training (+Ex); Other: Treatment as usual (TAU)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • University Medical Center Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychodynamic Motivation and Training Program (PMT)	Behavioral: 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.
Active Comparator: Advice in Exercise Training; One session of advice in exercise training based on the results of spiroergometry	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.
Other: Treatment as usual (TAU); Usual care by family doctor and cardiologist	Other: Treatment as usual (TAU); Usual care by family doctor, cardiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Matthias Michal, PD Dr. med., University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy

Publications and helpful links

General Publications

• Michal M, Simon P, Gori T, Konig J, Wild PS, Wiltink J, Tug S, Sterzing B, Unterrainer J, Munzel T, Beutel ME. Psychodynamic Motivation and Training program (PMT) for the secondary prevention in patients with stable coronary heart disease: study protocol for a randomized controlled trial of feasibility and effects. Trials. 2013 Sep 25;14:314. doi: 10.1186/1745-6215-14-314.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; secondary prevention; coronary heart disease; psychodynamic psychotherapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IRB 837.274.11 (7816)