Psychodynamic Motivation and Training Program (PMT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Johannes Gutenberg University Mainz.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Matthias Michal, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01445808
First received: September 30, 2011
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Physical Activity
Behavioral: Psychodynamic Motivation and Training Program (PMT)
Behavioral: Advice in Exercise Training (+Ex)
Other: Treatment as usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Change in individual anaerobic threshold according to lactate kinetics during spiroergometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life according to the EQ-5D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in endothelial function according to the flow mediated dilatation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in high density lipoprotein levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in biomarkers of inflammation and oxidative burst [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in fatigue according to the Maastricht Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in illness perception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    (Illness perception as measured with the Brief Illness Perception Questionnaire)

  • Change in maximal aerobic capacity (VO2 max) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    (BMI kg/m²)


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Treatment as usual (TAU)
Usual care by family doctor and cardiologist
Other: Treatment as usual (TAU)
Usual care by family doctor, cardiologist

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445808

Contacts
Contact: Matthias Michal 00496131173567 michal@uni-mainz.de

Locations
Germany
University Medical Center Mainz Recruiting
Mainz, Germany, 55131
Contact: Matthias Michal    00496131173567    michal@uni-mainz.de   
Sub-Investigator: Manfred E Beutel, Prof. Dr.         
Sub-Investigator: Tommaso Gori, Dr.         
Sub-Investigator: Perikles Simon, Prof. Dr. Dr.         
Sub-Investigator: Thomas Münzel, Prof. Dr.         
Sub-Investigator: Jörg Wiltink, Dr.         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Matthias Michal, PD Dr. med. University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
  More Information

No publications provided by Johannes Gutenberg University Mainz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthias Michal, PD Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01445808     History of Changes
Other Study ID Numbers: IRB 837.274.11 (7816)
Study First Received: September 30, 2011
Last Updated: March 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
psychodynamic psychotherapy
coronary heart disease
physical activity
secondary prevention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014