Feasibility Trial of the Early Psychological Support for the Critically Ill

February 27, 2023 updated by: Lioudmila Karnatovskaia, Mayo Clinic
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Psychological Support for the Critically Ill (EPSCI)
patients will receive EPSCI in parallel with medical treatment
Behavioral: Early Psychological Support for the Critically Ill (EPSCI)
early psychological support based on positive therapeutic suggestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Events Scale-Revised (IES-R) score
Time Frame: 1 year
rate of PTSD following ICU stay
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
Hospital Anxiety and Depression Scale (HADS) score
Time Frame: 1 year
rate of anxiety and depression following intensive care unit (ICU) stay
1 year
Montreal Cognitive Assessment-Blind (MoCA-blind) score
Time Frame: 1 year
rate of cognitive dysfunction following ICU stay
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Lioudmila V Karnatovskaia, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-000145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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