Positive Suggestions Via MP3 Messages

NCT04437095 | Completed

• 1 other identifier: 20-003735
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.

Conditions

Post Intensive Care Unit Syndrome; Psychological Trauma; Anxiety; Depression; PTSD

Keywords

Post traumatic stress syndrome; Anxiety; Depression; PICS

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS) - Anxiety

  A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \> 11: Abnormal. Total questions: 14 Anxiety 7 Depression 7 A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \> 11: Abnormal. TL questions: 14: Anxiety 7, Depression 7

  within 96 hours of ICU discharge

Secondary Outcomes (9)

• Impact of Events Scale-Revised

  within 96 hours of ICU discharge

• Montreal Cognitive Assessment-Blind (MoCA-blind)

  within 96 hours of ICU discharge

• EQ-5D

  within 96 hours of ICU discharge

• Hospital Anxiety and Depression Scale (HADS) - Depression

  within 96 hours of ICU discharge

• Hospital Anxiety and Depression Scale (HADS) - Depression

  6 months following ICU discharge

Study Arms (2)

PSBPS Audiorecording

EXPERIMENTAL

Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones

Other: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message

Control

NO INTERVENTION

Standard of care

Interventions

Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message OTHER

Daily administration of audiorecording

PSBPS Audiorecording

Eligibility Criteria

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

You may qualify if:

• Acute respiratory failure and/or requiring vasopressors
• Admitted to the ICU
• Expected to stay \>48 hours in the ICU

You may not qualify if:

• History of dementia
• History of mental retardation
• History of suicide attempt
• History of 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
• Those with hearing impairment
• Non-English speaking.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Psychological Trauma; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lioudmila Karnatovskaia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: Patients will be randomized 1:1 to intervention vs standard care. Using data from our prior observational study, mean (SD) HADS-Anxiety subscale was 7.3 (4.1) among these subjects (coefficient of variation = 4.1/7.3 = 0.56). A total 300 subjects will be enrolled and randomized until 100 subjects per arm recruitment target is reached to allow for mortality and dropout. The analysis will compare 6 month HADS-A by treatment arms using ANCOVA. The analysis will be conducted under a modified intention to treat principle, with subjects analyzed according to randomized arm, but excluding patients who die before follow up. Additional outcomes including HADS-D, MoCA-blind, and EQ-5D will be analyzed similarly using ANCOVA, and IES-R subscore\>1.6 will be analyzed by Chi-square test.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: August 17, 2020
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)