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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 below
Select...
I am an adult in critical condition needing breathing support and expected to stay in care for more than 48 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 96 hours after icu discharge and 3 months after hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 96 hours after icu discharge and 3 months after hospital discharge for reporting.

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,270 Total Patients Enrolled
17 Trials studying Critical Illness
42,530 Patients Enrolled for Critical Illness

Media Library

Psychological Support Based on Positive Suggestions (PSBPS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04045210 — N/A
Critical Illness Research Study Groups: No Intervention, Doula
Critical Illness Clinical Trial 2023: Psychological Support Based on Positive Suggestions (PSBPS) Highlights & Side Effects. Trial Name: NCT04045210 — N/A
Psychological Support Based on Positive Suggestions (PSBPS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04045210 — N/A
~31 spots leftby Jun 2025
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