Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function

NACompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

August 30, 2019

Primary Completion Date

January 31, 2025

Study Completion Date

March 15, 2025

Conditions
Critical Illness
Interventions
OTHER

Psychological Support Based on Positive Suggestions

Eligible patients will be randomized at the earliest possible time after meeting inclusion criteria. Patients will be randomized 1:1 to intervention by ICU doulas or a non-intervention arms stratified by ICU location. Both intervention and controls will receive standard medical care at the discretion of the ICU team. The intervention arm will receive PSBPS as soon as feasible and continue on a daily basis. Doulas will also liaise with family, the team, and with the nursing staff. Both intervention and standard of care arms will complete follow-up questionnaires measuring symptoms of anxiety, depression, acute stress and cognitive function after ICU discharge and at 3 months follow up by phone. All the patients randomized to the intervention arm will receive the same intervention.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT04045210 - Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function | Biotech Hunter | Biotech Hunter