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Completed

NCT Number: NCT02739022

Feasibility Trial of the Early Psychological Support for the Critically Ill

This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)

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Key information

Conditions

PICS

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

critically ill adults admitted to the medical intensive care unit (ICU) and expected to stay >48 hours

Inclusion criteria

-mechanically ventilated patients receiving vasopressors

Exclusion criteria

  • history of dementia
  • mental retardation
  • suicide attempt
  • psychotic disorders such as schizophrenia
  • patients on comfort care non-English speaking.

Treatment and study plan

Early Psychological Support for the Critically Ill (EPSCI)

Behavioral

early psychological support based on positive therapeutic suggestion

Primary outcomes

  1. Impact of Events Scale-Revised (IES-R) score

    Time frame: 1 year

    rate of PTSD following ICU stay

Secondary outcomes

  1. feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)

    Time frame: 1 year

    how much time therapy takes, how many interruptions, feedback from staff/family/patient

  2. Hospital Anxiety and Depression Scale (HADS) score

    Time frame: 1 year

    rate of anxiety and depression following intensive care unit (ICU) stay

  3. Montreal Cognitive Assessment-Blind (MoCA-blind) score

    Time frame: 1 year

    rate of cognitive dysfunction following ICU stay

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Mar 1, 2023

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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