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NCT03736954 · ClinicalTrials.gov registry record · NA

ICU Doulas Providing Psychological Support

A NA study, sponsored by Mayo Clinic.

Completed
Registry status
NA
Development phase
42
Enrollment target

NCT03736954: Completed NA study, sponsored by Mayo Clinic.

NCT03736954 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03736954, a NA study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target

Study Summary

Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. Research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. This means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the ICU. The Researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. However, providing consistent psychological support intervention is a challenge for busy ICU clinicians. It is not feasible to hire behavioral medicine trained psychologists to become permanent ICU staff nationwide. Doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. Given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU. This will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback

Interventions

  • BEHAVIORAL positive suggestion

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2018-11-12
Est. Completion 2021-12-31
Phase NA

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT03736954

The ClinicalTrials.gov registry entry for NCT03736954 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which positive suggestion is the first listed.

NCT03736954 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03736954 about?

NCT03736954 is a clinical study titled "ICU Doulas Providing Psychological Support". Many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (PTSD) after leaving the intensive care unit (ICU). Memories of frightening and delusional experiences in the ICU appear to be the strongest potentially modifiable risk factor. R...

What is the current status of trial NCT03736954?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2018-11-12. Estimated completion is 2021-12-31.

What interventions are being tested in trial NCT03736954?

The interventions under investigation include: positive suggestion (BEHAVIORAL).

Who is sponsoring clinical trial NCT03736954?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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