Psychodynamic Motivation and Training Program (PMT)
Primary Purpose
Coronary Heart Disease, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Psychodynamic Motivation and Training Program (PMT)
Advice in Exercise Training (+Ex)
Treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring psychodynamic psychotherapy, coronary heart disease, physical activity, secondary prevention
Eligibility 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
Sites / Locations
- University Medical Center Mainz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Psychodynamic Motivation and Training Program (PMT)
Advice in Exercise Training
Treatment as usual (TAU)
Arm Description
One session of advice in exercise training based on the results of spiroergometry
Usual care by family doctor and cardiologist
Outcomes
Primary Outcome Measures
Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
Secondary Outcome Measures
Change in quality of life according to the EQ-5D
Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire
Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire
Change in endothelial function according to the flow mediated dilatation
Change in high density lipoprotein levels
Change in biomarkers of inflammation and oxidative burst
Change in fatigue according to the Maastricht Questionnaire
Change in illness perception
(Illness perception as measured with the Brief Illness Perception Questionnaire)
Change in maximal aerobic capacity (VO2 max)
Change in body mass index
(BMI kg/m²)
Full Information
NCT ID
NCT01445808
First Posted
September 30, 2011
Last Updated
February 25, 2016
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT01445808
Brief Title
Psychodynamic Motivation and Training Program
Acronym
PMT
Official Title
Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Physical Activity
Keywords
psychodynamic psychotherapy, coronary heart disease, physical activity, secondary prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychodynamic Motivation and Training Program (PMT)
Arm Type
Experimental
Arm Title
Advice in Exercise Training
Arm Type
Active Comparator
Arm Description
One session of advice in exercise training based on the results of spiroergometry
Arm Title
Treatment as usual (TAU)
Arm Type
Other
Arm Description
Usual care by family doctor and cardiologist
Intervention Type
Behavioral
Intervention Name(s)
Psychodynamic Motivation and Training Program (PMT)
Intervention Description
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
Intervention Name(s)
Advice in Exercise Training (+Ex)
Intervention Description
Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Usual care by family doctor, cardiologist
Primary Outcome Measure Information:
Title
Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in quality of life according to the EQ-5D
Time Frame
6 months
Title
Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire
Time Frame
6 Months
Title
Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire
Time Frame
6 months
Title
Change in endothelial function according to the flow mediated dilatation
Time Frame
6 months
Title
Change in high density lipoprotein levels
Time Frame
6 months
Title
Change in biomarkers of inflammation and oxidative burst
Time Frame
6 months
Title
Change in fatigue according to the Maastricht Questionnaire
Time Frame
6 months
Title
Change in illness perception
Description
(Illness perception as measured with the Brief Illness Perception Questionnaire)
Time Frame
6 months
Title
Change in maximal aerobic capacity (VO2 max)
Time Frame
6 months
Title
Change in body mass index
Description
(BMI kg/m²)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Michal, PD Dr. med.
Organizational Affiliation
University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24066805
Citation
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.
Results Reference
derived
Learn more about this trial
Psychodynamic Motivation and Training Program
We'll reach out to this number within 24 hrs