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Completed

NCT Number: NCT03736954

ICU Doulas Providing Psychological Support

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

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Key information

Conditions

Illness, Critical Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Critical Illness Depression Disease Attributes Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

positive suggestion

Behavioral

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

Primary outcomes

  1. 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

  1. Patient scores on Hospital Anxiety and Depression Scale

    Time frame: 6 months

    quantitative. Study patients will complete follow-up questionnaires measuring symptoms of anxiety and depression following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.

  2. Patient scores on Impact of Events Scale - Revised

    Time frame: 6 months

    quantitative. Study patients will complete follow-up questionnaires measuring symptoms of acute stress following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.

  3. Patient scores on Montreal Cognitive Assessment-blind

    Time frame: 6 months

    quantitative. Study patients will complete follow-up questionnaires measuring cognitive function following ICU discharge but prior to hospital discharge. Patient's scores on these questionnaires will be compared to propensity-matched historic cohort.

  4. Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients

    Time frame: 6 months

    We will use an "interpretive description approach" to qualitative research, which creates an interpretive account of a clinical phenomenon for the purpose of informing clinical practice. We aim to understand the changes in experiences of critically ill patients, their family members, and providers through the interviews. This allows us to explore patient and key stakeholders' perspectives and to refine PSBPS based on the areas of highest priority, focusing on elements that are deemed by patients to be of highest acceptability. Following patient ICU discharge, interviews will be conducted on a one-on-one basis by the candidate or a trained qualitative interviewer who is not directly involved in the patient's clinical care; participants will be assured that interview transcripts will be confidential. Interviews will last approximately 15 minutes and will be conducted in person.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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