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COMPLETED
NCT04045210
NA

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

The Researchers are trying to evaluate efficacy of a psychotherapeutic approach that can be applied to those who are critically ill. The daily approach in the Intensive Care Unit (ICU) is designed to provide patients with psychological support, reassurance, and explanations of where they are and what is happening to them.

Official title: Randomized Controlled Trial to Evaluate Efficacy of Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive Function

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2019-08-30

Completion Date

2025-03-15

Last Updated

2026-08-21

Healthy Volunteers

No

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 6 months follow up by phone. All the patients randomized to the intervention arm will receive the same intervention.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States