An interventional study of positive suggestion in Illness, Critical, Anxiety and Depression, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
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
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's enrollment of 42 is below the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
specially trained ICU doulas will provide critically ill intubated patients with early psychological support on a daily basis
Behavioral: positive suggestion
humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants
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.
Time frame: 6 months
Patient scores on Hospital Anxiety and Depression Scale
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.
Time frame: 6 months
Patient scores on Impact of Events Scale - Revised
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.
Time frame: 6 months
Patient scores on Montreal Cognitive Assessment-blind
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.
Time frame: 6 months
Qualitative interviews of patients, their family members, physicians and nurses caring for the study patients
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.
Time frame: 6 months
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.