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Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction

Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00769366
Acronym
STEP-IN-AMI
Enrollment
101
Registered
2008-10-09
Start date
2005-06-02
Completion date
2016-11-01
Last updated
2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Brief summary

Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy. The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.

Interventions

BEHAVIORALPsychotherapy

humanistic-existential psychotherapy conducted in individual and group meetings

DRUGMedical therapy

Optimal medical therapy after Acute myocardial infarction

Sponsors

San Filippo Neri General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients admitted to San Filippo Neri Hospital for AMI and treated with primary or urgent PCI. * Primary PTCA is performed up to 12 hours after the beginning of chest pain in cases of STEMI, while patients with NSTEMI are enrolled if urgent PTCA is being performed within 48 hours of the onset of chest pain. * Only patients in whom complete revascularization is achieved are being enrolled in the study.

Exclusion criteria

* Patients with psychiatric disorders or disability, cognitive impairment, or other life-threatening conditions are being excluded from the study.

Design outcomes

Primary

MeasureTime frame
The cumulative incidence of new cardiological events and the occurrence of new medical pathologies5 years

Secondary

MeasureTime frame
Incidence of re-hospitalisations5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026