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DepressionSPIRR-CADNCT00705965

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

A study testing Psychotherapy, Information session and Usual cardiological care in people with Depression and Coronary Artery Disease, run by University of Göttingen at 10 sites 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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression, Coronary Artery Disease
What is being tested?
Psychotherapy, Information session and Usual cardiological care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
10 sitesGermany
Study dates
Nov 2008to Apr 2013
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

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

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

    Berlin, D-12200

  • University of Cologne, Dept. Psychosomatics and Psychotherapy

    Cologne, D-50931

  • Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics

    Dresden, D-01307

  • University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy

    Freiburg im Breisgau, D-79104

  • University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy

    Göttingen, D-37075

  • Hannover Medical School, Dept. of Psychosomatics and Psychotherapy

    Hanover, D-30625

  • University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine

    Heidelberg, D-69120

  • University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy

    Mainz, D-55131

  • Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology

    München, D- 81675

  • Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy

    Nuremberg, D-90419

Other trials in Germany

About this study

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

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.

Being tested
Psychotherapy, Information session, Usual cardiological care
Keywords
Coronary artery disease, depression, psychotherapy, randomized controlled trial
Medical subject headings
Depression, Coronary Artery Disease

What participants receive

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

  • PsychotherapyBehavioural

    Also called Stepwise manualized psychotherapy

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

  • Information sessionBehavioural

    One information session about living with heart disease.

  • Usual cardiological careOther

    Usual cardiological care

Study groups in NCT00705965
Study groupRoleWhat they receive
1ExperimentalStepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
Receives: Behavioral: Psychotherapy; Other: Usual cardiological care
2Active comparatorUsual cardiological care including one information session.
Receives: Behavioral: Information session; Other: Usual cardiological care

What is being measured

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

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

    Measured: 18 months

Secondary outcomes (8)

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

    Measured: 18 months

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

    Measured: 18 months

  3. cardiovascular risk profile

    Measured: 18 months

  4. neuroendocrine and immunological activation

    Measured: 18 months

  5. coagulation

    Measured: 18 months

  6. heart rate variability

    Measured: 18 months

  7. cardiac events

    Measured: 18 months

  8. health care utilisation and costs

    Measured: 18 months

Timeline

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

  1. First posted27 Jun 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2013
  4. Study completionApr 2013

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
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00705965
Sponsor's protocol ID
ZKSK-371
Acronym
SPIRR-CAD
Status last verified
Aug 2016
First submitted
25 Jun 2008
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Albus C, Beutel ME, Deter HC, Fritzsche K, Hellmich M, Jordan J, Juenger J, Krauth C, Ladwig KH, Michal M, Mueck-Weymann M, Petrowski K, Pieske B, Ronel J, Soellner W, Waller C, Weber C, Herrmann-Lingen C. A stepwise psychotherapy intervention for reducing risk in coronary artery disease (SPIRR-CAD) - rationale and design of a multicenter, randomized trial in depressed patients with CAD. J Psychosom Res. 2011 Oct;71(4):215-22. doi: 10.1016/j.jpsychores.2011.02.013. Epub 2011 Apr 15.

    PubMed 21911098

  • Herrmann-Lingen C, Beutel ME, Bosbach A, Deter HC, Fritzsche K, Hellmich M, Jordan J, Junger J, Ladwig KH, Michal M, Petrowski K, Pieske B, Ronel J, Sollner W, Stohr A, Weber C, de Zwaan M, Albus C; SPIRR-CAD Study Group. A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD): Results of an Observer-Blinded, Multicenter, Randomized Trial in Depressed Patients With Coronary Artery Disease. Psychosom Med. 2016 Jul-Aug;78(6):704-15. doi: 10.1097/PSY.0000000000000332.

    PubMed 27187851

  • Fangauf SV, Meyer T, Albus C, Binder L, Deter HC, Ladwig KH, Michal M, Ronel J, Rothenberger A, Sollner W, Wachter R, Weber CS, Herrmann-Lingen C; SPIRR-CAD group. Longitudinal relationship between B-type natriuretic peptide and anxiety in coronary heart disease patients with depression. J Psychosom Res. 2019 Aug;123:109728. doi: 10.1016/j.jpsychores.2019.05.006. Epub 2019 May 21.

    PubMed 31376874

  • Vitinius F, Escherich S, Deter HC, Hellmich M, Junger J, Petrowski K, Ladwig KH, Lambertus F, Michal M, Weber C, de Zwaan M, Herrmann-Lingen C, Ronel J, Albus C. Somatic and sociodemographic predictors of depression outcome among depressed patients with coronary artery disease - a secondary analysis of the SPIRR-CAD study. BMC Psychiatry. 2019 Feb 4;19(1):57. doi: 10.1186/s12888-019-2026-6.

    PubMed 30717711

  • Sollner W, Muller MM, Albus C, Behnisch R, Beutel ME, de Zwaan M, Fritzsche K, Habermeier A, Hellmich M, Jordan J, Junger J, Ladwig KH, Michal M, Petrowski K, Ronel J, Stein B, Weber C, Weber R, Herrmann-Lingen C. The relationship between attachment orientations and the course of depression in coronary artery disease patients: A secondary analysis of the SPIRR-CAD trial. J Psychosom Res. 2018 May;108:39-46. doi: 10.1016/j.jpsychores.2018.02.014. Epub 2018 Feb 24.

    PubMed 29602324

  • Orth-Gomer K, Deter HC, Grun AS, Herrmann-Lingen C, Albus C, Bosbach A, Ladwig KH, Ronel J, Sollner W, de Zwaan M, Petrowski K, Weber C; SPIRR-CAD Study Group. Socioeconomic factors in coronary artery disease - Results from the SPIRR-CAD study. J Psychosom Res. 2018 Feb;105:125-131. doi: 10.1016/j.jpsychores.2017.12.005. Epub 2017 Dec 5.

    PubMed 29332628

  • Lambertus F, Herrmann-Lingen C, Fritzsche K, Hamacher S, Hellmich M, Junger J, Ladwig KH, Michal M, Ronel J, Schultz JH, Vitinius F, Weber C, Albus C. Prevalence of mental disorders among depressed coronary patients with and without Type D personality. Results of the multi-center SPIRR-CAD trial. Gen Hosp Psychiatry. 2018 Jan-Feb;50:69-75. doi: 10.1016/j.genhosppsych.2017.10.001. Epub 2017 Oct 7.

    PubMed 29078170

Questions about this trial

What is this clinical trial studying?

A study testing Psychotherapy, Information session and Usual cardiological care in people with Depression and Coronary Artery Disease, run by University of Göttingen at 10 sites 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 6 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Changes from baseline to 18 months in depressive symptoms (HADS-D) (time frame: 18 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 NCT00705965, which also lists 7 linked publications.

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 30 Aug 2016.

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