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Completed

NCT Number: NCT00705965

Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease

In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with coronary artery disease
  • German speaking men and women
  • Recent coronary angiogram (<= 3 months old)
  • Depression score (HADS-D) >= 8
  • Written informed consent

Exclusion criteria

  • Severe heart failure
  • Other acutely life- threatening conditions
  • Severe chronic inflammatory disease
  • Current suicidal tendency
  • Severe depressive episode
  • Other severe mental illness.

Treatment and study plan

Psychotherapy

Behavioral

Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.

Other names: Stepwise manualized psychotherapy

Information session

Behavioral

One information session about living with heart disease.

Usual cardiological care

Other

Usual cardiological care

Primary outcomes

  1. Changes from baseline to 18 months in depressive symptoms (HADS-D)

    Time frame: 18 months

Secondary outcomes

  1. Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)

    Time frame: 18 months

  2. Health-related quality of life (SF36, EuroQuol-5D)

    Time frame: 18 months

  3. cardiovascular risk profile

    Time frame: 18 months

  4. neuroendocrine and immunological activation

    Time frame: 18 months

  5. coagulation

    Time frame: 18 months

  6. heart rate variability

    Time frame: 18 months

  7. cardiac events

    Time frame: 18 months

  8. health care utilisation and costs

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • German Research Foundation
  • Hannover Medical School
  • Heidelberg University
  • Humboldt-Universität zu Berlin
  • Johannes Gutenberg University Mainz
  • Kerckhoff Rehabilitation Center Bad Nauheim
  • Medical University of Graz
  • Nuremberg General Hospital
  • Technical University of Munich
  • Technische Universität Dresden
  • The Clinical Trials Centre Cologne
  • University Hospital Freiburg
  • University of Cologne

Registry information

Official study title

A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

Acronym: SPIRR-CAD

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2008
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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