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.
BACKGROUND
Nonpharmacological secondary prevention of coronary heart disease is considered a safe and effective measure to substantially reduce mortality. Despite the effectiveness of lifestyle changes, the compliance rate of patients is very low mainly due to psychosocial barriers. Psychotherapeutic approaches that address how persons think about themselves and their behaviors appear to have a significant potential for improving health behavior.


METHODS
Against this background, our study aims to examine the feasibility and effects of a Psychodynamic Motivation and Training program (PMT) as compared to one session of advice in exercise training (EX) and treatment as usual (TAU). For that purpose, 90 patients with stable coronary heart disease and a physically inactive lifestyle will be randomly assigned to the three groups (each with n = 30). The primary outcome is the change in the individual anaerobic threshold as determined by spiroergometry from baseline to six month follow-up. Secondary endpoints include change in endothelial function, biomarkers of inflammation and oxidative stress, quality of life, symptoms of fatigue, illness perception and feasibility of the treatment approach. We hypothesize that physical fitness will improve more in PMT than in EX and TAU, with PMT and EX more than TAU, and that the effects will be more pronounced for participants with current mental or psychosocial distress.


CONCLUSIONS
The results of the study will help to determine the effectiveness of a psychodynamic lifestyle change approach and to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.


BACKGROUND
ClinicalTrials.gov Identifier: NCT01445808.
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Untere Zahlbacher Strasse 8, Mainz 55131, Germany. michal@uni-mainz.de.
Matthias
M
Michal
Perikles
P
Simon
Tommaso
T
Gori
Jochem
J
König
Philipp S
PS
Wild
Jörg
J
Wiltink
Suzan
S
Tug
Björn
B
Sterzing
Josef
J
Unterrainer
Thomas
T
Münzel
Manfred E
ME
Beutel
D015415:Biomarkers / Q000097:blood; D003071:Cognition; D003327:Coronary Disease / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D004730:Endothelium, Vascular / Q000378:metabolism / Q000503:physiopathology; D005081:Exercise Therapy; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005858:Germany; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009042:Motivation; D010349:Patient Compliance; D064889:Psychotherapy, Psychodynamic; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D040242:Risk Reduction Behavior; D055502:Secondary Prevention / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers