MedTrace Logo

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

NCT04045210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-05-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2025-01-31
Completion
2025-03-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045210 on ClinicalTrials.gov