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Feasibility Trial of the Early Psychological Support for the Critically Ill

Primary Purpose

PICS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Psychological Support for the Critically Ill (EPSCI)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PICS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early Psychological Support for the Critically Ill (EPSCI)

Arm Description

patients will receive EPSCI in parallel with medical treatment

Outcomes

Primary Outcome Measures

Impact of Events Scale-Revised (IES-R) score
rate of PTSD following ICU stay

Secondary Outcome Measures

feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)
how much time therapy takes, how many interruptions, feedback from staff/family/patient
Hospital Anxiety and Depression Scale (HADS) score
rate of anxiety and depression following intensive care unit (ICU) stay
Montreal Cognitive Assessment-Blind (MoCA-blind) score
rate of cognitive dysfunction following ICU stay

Full Information

First Posted
March 16, 2016
Last Updated
February 27, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02739022
Brief Title
Feasibility Trial of the Early Psychological Support for the Critically Ill
Official Title
Feasibility Trial of the Early Psychological Support for the Critically Ill
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PICS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Psychological Support for the Critically Ill (EPSCI)
Arm Type
Experimental
Arm Description
patients will receive EPSCI in parallel with medical treatment
Intervention Type
Behavioral
Intervention Name(s)
Early Psychological Support for the Critically Ill (EPSCI)
Intervention Description
early psychological support based on positive therapeutic suggestion
Primary Outcome Measure Information:
Title
Impact of Events Scale-Revised (IES-R) score
Description
rate of PTSD following ICU stay
Time Frame
1 year
Secondary Outcome Measure Information:
Title
feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)
Description
how much time therapy takes, how many interruptions, feedback from staff/family/patient
Time Frame
1 year
Title
Hospital Anxiety and Depression Scale (HADS) score
Description
rate of anxiety and depression following intensive care unit (ICU) stay
Time Frame
1 year
Title
Montreal Cognitive Assessment-Blind (MoCA-blind) score
Description
rate of cognitive dysfunction following ICU stay
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lioudmila V Karnatovskaia
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32730136
Citation
Tan Y, Gajic O, Schulte PJ, Clark MM, Philbrick KL, Karnatovskaia LV. Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Int J Clin Exp Hypn. 2020 Oct-Dec;68(4):419-432. doi: 10.1080/00207144.2020.1795663. Epub 2020 Jul 30.
Results Reference
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Feasibility Trial of the Early Psychological Support for the Critically Ill

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