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intErnet-based iNterventions FOR Cardiac arrEst suRvivors (ENFORCER)

A

Azienda Usl di Bologna

Status

Enrolling

Conditions

Cognitive Impairment
Quality of Life
Depression, Anxiety
Sexual Dysfunction
Social Functioning
Cardiac Arrest

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06395558
ENFORCER

Details and patient eligibility

About

Anxiety, depression and cognitive impairment symptoms are common among cardiac arrest survivors. This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster anxiety and depression symptoms in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms

Enrollment

137 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
  • HADS anxiety or depression ≥ 8 and/or TICS ≤ 31
  • Informed consent for participation in the study
  • Native Italian speaker or adequate understanding of the Italian language
  • Adequate ability to use the web to guarantee access to the contents

Exclusion criteria

  • Previous cognitive dysfunction
  • Previous psychiatric disease
  • Previous episode of out-of-hospital cardiac arrest

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

137 participants in 2 patient groups

Lifestyle intervention
Experimental group
Treatment:
Behavioral: Lifestyle intervention
Control
No Intervention group

Trial contacts and locations

2

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Central trial contact

Pamela Salucci, MD; Lorenzo Gamberini, MD

Data sourced from clinicaltrials.gov

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