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

NCT04045210 | Completed

• 1 other identifier: 19-004660
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• minimal important change in hospital anxiety and depression scale - Anxiety

  This outcome will be evaluated using Hospital Anxiety and Depression Scale (HADS). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained from the control group and the two intervention groups within 96 hours after ICU discharge and at 6 months follow up

  within 96 hours after ICU discharge and 3 months after hospital discharge

Secondary Outcomes (1)

• minimal important change in hospital anxiety and depression scale-Depression

  within 96 hours after ICU discharge and 3 months after hospital discharge

Other Outcomes (3)

• minimal important change in Impact of Event Scale-Revised

  within 96 hours after ICU discharge and 3 months after hospital discharge

• statistically significant improvement in MoCA-blind

  within 96 hours after ICU discharge and 3 months after hospital discharge

• EQ-5D-3L

  within 96 hours after ICU discharge and 3 months after hospital discharge

Study Arms (2)

No Intervention

NO INTERVENTION

Doula

EXPERIMENTAL

Other: Psychological Support Based on Positive Suggestions

Interventions

Psychological Support Based on Positive Suggestions OTHER

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.

Doula

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Critically ill adult patients (age \>18) requiring non-invasive ventilation, high flow O2 or mechanical ventilation and expected to stay \>48 hours.

You may not qualify if:

• history of dementia
• intellectual disability
• 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
• Non-English speaking.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a tho arm single-center, prospective, randomized, controlled trial comparing the effect of PSBPS vs. no PSBPS on psychological and clinical outcomes in the critically ill population. PSBPS will be administered by trained ICU doulas to eligible patients

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 5, 2019
• Study Start: August 30, 2019
• Primary Completion: January 31, 2025
• Study Completion: March 15, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)