A Study of a Psychotherapeutic Approach Applied to Those Who are Critically Ill to Provide Patients with Psychological Support
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-008755
NCT ID: NCT03736954
Sponsor Protocol Number: 17-008755
About this study
The objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the ICU.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults (age >18) admitted to the ICU and expected to stay >48 hours.
- Critically ill adult patients requiring vasopressor support or mechanical ventilation.
- Patients with respiratory distress and on BiPAP/CPAP/High flow oxygen.
- Willing patient’s family member; critical care nurses taking care of patients receiving EPSCI.
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 or non-English speaking.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
-
Over a third of critical illness survivors suffer from mental health problems following hospitalization. Memories of delusional experiences are a major risk factor. In this project, ICU doulas delivered a unique positive suggestion intervention targeting the vulnerable time period during critical illness when these memories are formed.
Read More on PubMed
-
Surviving critical illness often creates a lasting psychological impact, including depression, anxiety, and post-traumatic stress. Memories of frightening and delusional experiences are the largest potentially modifiable risk factor, but currently, there is no proven intervention to improve these inciting factors. Psychological support based on positive suggestion is a psychotherapeutic approach that can be provided even to patients in altered cognitive states and is therefore a viable psychotherapy intervention throughout the ICU stay. Traditional ICU care team members have limited time and training to provide such psychological support to patients. Doulas are trained supportive companions who have been effectively used to provide patient advocacy and emotional support in other clinical settings and may address this need. Our aim was to train and implement a psychological support based on positive suggestion program for the critically ill using doulas, and measure acceptance of this intervention through stakeholder feedback.
Read More on PubMed