NCT03736954

ICU Doulas Providing Psychological Support

Completed NA Last updated 8 March 2022

What this trial tests

NA trial testing positive suggestion in Illness, Critical in 42 participants. Completed in 31 December 2021.

Timeline

12 November 2018

Primary endpoint
9 May 2019

31 December 2021

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	42
Start date	12 November 2018
Primary completion	9 May 2019
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• positive suggestion

Conditions studied

• Illness, Critical — all drugs for Illness, Critical →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →
• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Illness, Critical or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A pilot study of trained ICU doulas providing early psychological support to critically ill patients.
   Karnatovskaia LV, Varga K, Niven AS, Schulte PJ, et al · · 2021 · cited 6× · PMID 34930440 · DOI 10.1186/s13054-021-03856-3
2. System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas.
   Karnatovskaia LV, Schultz JM, Niven AS, Steele AJ, et al · · 2021 · cited 5× · PMID 33912833 · DOI 10.1097/cce.0000000000000403