ICU Doulas Providing Psychological Support

NCT ID: NCT03736954

Last Updated: 2022-03-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Illness, Critical Anxiety Depression Post Traumatic Stress Disorder Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

pilot study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU doulas intervention

specially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis

Group Type EXPERIMENTAL

positive suggestion

Intervention Type BEHAVIORAL

humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

positive suggestion

humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lioudmila Karnatovskaia

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lioudmila V Karnatovskaia

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Karnatovskaia LV, Varga K, Niven AS, Schulte PJ, Mujic M, Gajic O, Bauer BA, Clark MM, Benzo RP, Philbrick KL. A pilot study of trained ICU doulas providing early psychological support to critically ill patients. Crit Care. 2021 Dec 20;25(1):446. doi: 10.1186/s13054-021-03856-3.

Reference Type BACKGROUND
PMID: 34930440 (View on PubMed)

Karnatovskaia LV, Schultz JM, Niven AS, Steele AJ, Baker BA, Philbrick KL, Del Valle KT, Johnson KR, Gajic O, Varga K. System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Crit Care Explor. 2021 Apr 26;3(4):e0403. doi: 10.1097/CCE.0000000000000403. eCollection 2021 Apr.

Reference Type BACKGROUND
PMID: 33912833 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-008755

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Deep Brain Stimulation for Treatment Refractory PTSD
NCT03416894 ACTIVE_NOT_RECRUITING NA
ICU-VR Prior to ICU Admission
NCT06642636 RECRUITING NA