Feasibility Trial of the Early Psychological Support for the Critically Ill

PICS Clinical Trial

Official title:

Feasibility Trial of the Early Psychological Support for the Critically Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739022
• Other study ID #: 16-000145
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• PICS

Intervention

Behavioral:
• Early Psychological Support for the Critically Ill (EPSCI)
early psychological support based on positive therapeutic suggestion

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Events Scale-Revised (IES-R) score	rate of PTSD following ICU stay	1 year
Secondary	feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)	how much time therapy takes, how many interruptions, feedback from staff/family/patient	1 year
Secondary	Hospital Anxiety and Depression Scale (HADS) score	rate of anxiety and depression following intensive care unit (ICU) stay	1 year
Secondary	Montreal Cognitive Assessment-Blind (MoCA-blind) score	rate of cognitive dysfunction following ICU stay	1 year