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Feasibility Trial of the Early Psychological Support for the Critically Ill

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by Lioudmila Karnatovskaia, Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Lioudmila Karnatovskaia, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02739022
First received: March 16, 2016
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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 Intervention
PICS
Behavioral: Early Psychological Support for the Critically Ill (EPSCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Trial of the Early Psychological Support for the Critically Ill

Further study details as provided by Lioudmila Karnatovskaia, Mayo Clinic:

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


Secondary Outcome Measures:
  • 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

  • Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: 1 year ]
    rate of anxiety and depression following intensive care unit (ICU) stay

  • Montreal Cognitive Assessment-Blind (MoCA-blind) score [ Time Frame: 1 year ]
    rate of cognitive dysfunction following ICU stay


Estimated Enrollment: 15
Study Start Date: April 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02739022

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Lioudmila V Karnatovskaia Mayo Clinic
  More Information

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
Study First Received: March 16, 2016
Last Updated: April 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2017