Psychodynamic Motivation and Training Program

NCT01445808 | Completed

• 1 other identifier: IRB 837.274.11 (7816)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Physical Activity

Keywords

psychodynamic psychotherapy; coronary heart disease; physical activity; secondary prevention

Outcome Measures

Primary Outcomes (1)

• Change in individual anaerobic threshold according to lactate kinetics during spiroergometry

  6 months

Secondary Outcomes (10)

• 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

Study Arms (3)

Psychodynamic Motivation and Training Program (PMT)

EXPERIMENTAL

Behavioral: Psychodynamic Motivation and Training Program (PMT)

Advice in Exercise Training

ACTIVE COMPARATOR

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

Behavioral: Advice in Exercise Training (+Ex)

Treatment as usual (TAU)

OTHER

Usual care by family doctor and cardiologist

Other: Treatment as usual (TAU)

Interventions

Psychodynamic Motivation and Training Program (PMT) 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.

Psychodynamic Motivation and Training Program (PMT)

Advice in Exercise Training (+Ex) BEHAVIORAL

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

Advice in Exercise Training

Treatment as usual (TAU) OTHER

Usual care by family doctor, cardiologist

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center Mainz

Mainz, 55131, Germany

Location

Related Publications (1)

• 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.

  PMID: 24066805 DERIVED

MeSH Terms

Conditions

Coronary Disease; Motor Activity

Interventions

Counseling; Exercise; Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthias Michal, PD Dr. med.

  University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 4, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

DE (1)