Feasibility Trial of the Early Psychological Support for the Critically Ill

NCT ID: NCT02739022

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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PICS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early Psychological Support for the Critically Ill (EPSCI)

patients will receive EPSCI in parallel with medical treatment

Group Type EXPERIMENTAL

Early Psychological Support for the Critically Ill (EPSCI)

Intervention Type BEHAVIORAL

early psychological support based on positive therapeutic suggestion

Interventions

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Early Psychological Support for the Critically Ill (EPSCI)

early psychological support based on positive therapeutic suggestion

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lioudmila Karnatovskaia

M.D., Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lioudmila V Karnatovskaia

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32730136 (View on PubMed)

Other Identifiers

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16-000145

Identifier Type: -

Identifier Source: org_study_id

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