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Behavioural Intervention
Psychological Support for Critical Illness
N/A
Recruiting
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Critically ill adult patients (age >18) requiring non-invasive ventilation, high flow O2 or mechanical ventilation and expected to stay >48 hours.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 96 hours after icu discharge and 3 months after hospital discharge
Awards & highlights
Study Summary
This trial is testing whether a daily psychotherapeutic approach can help critically ill patients.
Who is the study for?
This trial is for critically ill adults over 18 who need breathing support like non-invasive ventilation or mechanical ventilation and will likely stay in the ICU for more than 48 hours. It's not for those with dementia, severe brain dysfunction due to liver problems, on end-of-life care, unlikely to survive their hospital stay, don't speak English, have a history of serious mental illness or substance issues.Check my eligibility
What is being tested?
The study tests a psychological support method using positive suggestions given daily in the ICU. The goal is to see if this approach helps improve mental health and cognitive function in patients facing critical illnesses.See study design
What are the potential side effects?
Since this intervention involves psychological support rather than medication, traditional side effects are not expected. However, there may be emotional responses or discomfort related to discussing one’s condition and receiving reassurance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult in critical condition needing breathing support and expected to stay in care for more than 48 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 96 hours after icu discharge and 3 months after hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 96 hours after icu discharge and 3 months after hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
minimal important change in hospital anxiety and depression scale - Anxiety
Secondary outcome measures
minimal important change in hospital anxiety and depression scale-Depression
Other outcome measures
EQ-5D-3L
minimal important change in Impact of Event Scale-Revised
statistically significant improvement in MoCA-blind
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DoulaExperimental Treatment1 Intervention
Group II: No InterventionActive Control1 Intervention
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,901 Total Patients Enrolled
17 Trials studying Critical Illness
42,530 Patients Enrolled for Critical Illness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving care focused on my comfort.I have been diagnosed with a psychotic disorder like schizophrenia.You have an intellectual disability.You have a history of memory loss or forgetfulness.You are currently experiencing the effects of drugs or alcohol, or are going through withdrawal.You have attempted to harm yourself in the past.I am an adult in critical condition needing breathing support and expected to stay in care for more than 48 hours.I have a severe brain disorder due to a metabolic problem.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: No Intervention
- Group 2: Doula
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has enrollment been maximized for this clinical experiment?
"Affirmative. The information hosted on clinicaltrials.gov certifies that this trial is open to enrolling participants, initially posted on August 30th 2019 and most recently updated on October 11th 2022. 182 individuals will be accepted from a single site."
Answered by AI
Are elderly individuals being included in this experiment?
"This clinical trial is recruiting individuals who are aged 18 and below, up to the age of 99."
Answered by AI
Are there any available vacancies for individuals to participate in this research program?
"Affirmative, the clinicaltrials.gov website confirms that this medical trial is recruiting patients. The initial post was made on August 30th 2019 and it has been revised as of October 11th 2022. 182 participants from one location are required for successful completion of the study."
Answered by AI
May I apply to take part in this experiment?
"Prerequisites for entering this clinical trial include being of adult age (18 - 99) and having a critical diagnosis. 182 people are sought for the experiment in total."
Answered by AI
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