NCT02739022

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

March 16, 2016

Last Update Submit

February 27, 2023

Conditions

PICS

Outcome Measures

Primary Outcomes (1)

  • Impact of Events Scale-Revised (IES-R) score

    rate of PTSD following ICU stay

    1 year

Secondary Outcomes (3)

  • feasibility of administering Early Psychological Support for the Critically Ill (EPSCI)

    1 year

  • Hospital Anxiety and Depression Scale (HADS) score

    1 year

  • Montreal Cognitive Assessment-Blind (MoCA-blind) score

    1 year

Study Arms (1)

Early Psychological Support for the Critically Ill (EPSCI)

EXPERIMENTAL

patients will receive EPSCI in parallel with medical treatment

Behavioral: Early Psychological Support for the Critically Ill (EPSCI)

Interventions

Early Psychological Support for the Critically Ill (EPSCI)BEHAVIORAL

early psychological support based on positive therapeutic suggestion

Early Psychological Support for the Critically Ill (EPSCI)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanically ventilated patients receiving vasopressors

You may not qualify if:

  • history of dementia
  • mental retardation
  • suicide attempt
  • psychotic disorders such as schizophrenia
  • patients on comfort care non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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.

    PMID: 32730136BACKGROUND

Study Officials

  • Lioudmila V Karnatovskaia

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Assistant Professor of Medicine

Study Record Dates

First Submitted

March 16, 2016

First Posted

April 14, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)