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Clinical Trials/NCT03736954
NCT03736954
Completed
Not Applicable

Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness

Mayo Clinic1 site in 1 country42 target enrollmentNovember 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Illness, Critical
Sponsor
Mayo Clinic
Enrollment
42
Locations
1
Primary Endpoint
feasibility of integration of trained doulas into the ICU
Status
Completed
Last Updated
4 years ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
November 12, 2018
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lioudmila Karnatovskaia

assistant professor

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • adults (age \>18) admitted to the ICU requiring intubation or vasopressors and expected to stay \>48 hours.

Exclusion Criteria

  • history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy;
  • patients on comfort care;
  • patients not expected to survive the hospital stay
  • non-English speaking, deaf or mute
  • prisoners

Outcomes

Primary Outcomes

feasibility of integration of trained doulas into the ICU

Time Frame: 6 months

pilot feasibility study. Feasibility defined as ICU doulas being able to perform study intervention on 30 recruited patients for at least 10 minutes daily throughout patient's ICU course.

Secondary Outcomes

  • Patient scores on Impact of Events Scale - Revised(6 months)
  • Patient scores on Hospital Anxiety and Depression Scale(6 months)
  • Patient scores on Montreal Cognitive Assessment-blind(6 months)
  • Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients(6 months)

Study Sites (1)

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