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Coronary Heart DiseasePMTNCT01445808

Psychodynamic Motivation and Training Program

A study testing Psychodynamic Motivation and Training Program (PMT), Advice in Exercise Training (+Ex) and Treatment as usual (TAU) in people with Coronary Heart Disease and Physical Activity, run by Johannes Gutenberg University Mainz at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Heart Disease, Physical Activity
What is being tested?
Psychodynamic Motivation and Training Program (PMT), Advice in Exercise Training (+Ex) and Treatment as usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteGermany
Study dates
Oct 2011to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Mainz

    Mainz, 55131

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Psychodynamic Motivation and Training Program (PMT), Advice in Exercise Training (+Ex), Treatment as usual (TAU)
Keywords
psychodynamic psychotherapy, coronary heart disease, physical activity, secondary prevention
Medical subject headings
Coronary Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychodynamic Motivation and Training Program (PMT)Behavioural

    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.

  • Advice in Exercise Training (+Ex)Behavioural

    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)Other

    Usual care by family doctor, cardiologist

Study groups in NCT01445808
Study groupRoleWhat they receive
Psychodynamic Motivation and Training Program (PMT)ExperimentalNot described
Receives: Behavioral: Psychodynamic Motivation and Training Program (PMT)
Advice in Exercise TrainingActive comparatorOne session of advice in exercise training based on the results of spiroergometry
Receives: Behavioral: Advice in Exercise Training (+Ex)
Treatment as usual (TAU)OtherUsual care by family doctor and cardiologist
Receives: Other: Treatment as usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in individual anaerobic threshold according to lactate kinetics during spiroergometry

    Measured: 6 months

Secondary outcomes (10)

  1. Change in quality of life according to the EQ-5D

    Measured: 6 months

  2. Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire

    Measured: 6 Months

  3. Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire

    Measured: 6 months

  4. Change in endothelial function according to the flow mediated dilatation

    Measured: 6 months

  5. Change in high density lipoprotein levels

    Measured: 6 months

  6. Change in biomarkers of inflammation and oxidative burst

    Measured: 6 months

  7. Change in fatigue according to the Maastricht Questionnaire

    Measured: 6 months

  8. Change in illness perception

    (Illness perception as measured with the Brief Illness Perception Questionnaire)

    Measured: 6 months

  9. Change in maximal aerobic capacity (VO2 max)

    Measured: 6 months

  10. Change in body mass index

    (BMI kg/m²)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01445808
Sponsor's protocol ID
IRB 837.274.11 (7816)
Acronym
PMT
Status last verified
Feb 2016
First submitted
30 Sep 2011
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 24066805

Questions about this trial

What is this clinical trial studying?

A study testing Psychodynamic Motivation and Training Program (PMT), Advice in Exercise Training (+Ex) and Treatment as usual (TAU) in people with Coronary Heart Disease and Physical Activity, run by Johannes Gutenberg University Mainz at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in individual anaerobic threshold according to lactate kinetics during spiroergometry (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01445808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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