ICU Doulas Providing Psychological Support

NCT03736954 | Completed

• 1 other identifier: 17-008755
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Illness, Critical; Anxiety; Depression; Post Traumatic Stress Disorder; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• feasibility of integration of trained doulas into the ICU

  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.

  6 months

Secondary Outcomes (4)

• Patient scores on Hospital Anxiety and Depression Scale

  6 months

• Patient scores on Impact of Events Scale - Revised

  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 Arms (1)

ICU doulas intervention

EXPERIMENTAL

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

Behavioral: positive suggestion

Interventions

positive suggestion BEHAVIORAL

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

ICU doulas intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 34930440 BACKGROUND

• 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.

  PMID: 33912833 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Critical Illness; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Lioudmila V Karnatovskaia

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: pilot study

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: November 9, 2018
• Study Start: November 12, 2018
• Primary Completion: May 9, 2019
• Study Completion: December 31, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

US (1)