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Feasibility Trial of the Early Psychological Support for the Critically Ill

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ClinicalTrials.gov Identifier: NCT02739022
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lioudmila Karnatovskaia, Mayo Clinic

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
PICS Behavioral: Early Psychological Support for the Critically Ill (EPSCI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility Trial of the Early Psychological Support for the Critically Ill
Actual Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

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



Primary Outcome Measures :
  1. Impact of Events Scale-Revised (IES-R) score [ Time Frame: 1 year ]
    rate of PTSD following ICU stay


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739022


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lioudmila Karnatovskaia, MD    507-266-3958      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Lioudmila V Karnatovskaia Mayo Clinic

Responsible Party: Lioudmila Karnatovskaia, M.D., Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02739022     History of Changes
Other Study ID Numbers: 16-000145
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes