Clinical trial NCT03736954: ICU Doulas Providing Psychological Support
Official title: Pilot Study of ICU Doulas Providing Psychological Support Based on Positive Suggestions to Mitigate Psychological and Cognitive Sequelae of Critical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Illness, Critical
Anxiety
Depression
Post Traumatic Stress Disorder
Cognitive Impairment
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot study
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: feasibility of integration of trained doulas into the ICU
timeFrame: 6 months
Secondary outcomes:
measure: Patient scores on Hospital Anxiety and Depression Scale
timeFrame: 6 months
measure: Patient scores on Impact of Events Scale - Revised
timeFrame: 6 months
measure: Patient scores on Montreal Cognitive Assessment-blind
timeFrame: 6 months
measure: Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lioudmila V Karnatovskaia
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.