Skip to main content
OpenTrials
Completed

NCT Number: NCT04437095

Positive Suggestions Via MP3 Messages

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Intensive Care Unit Syndrome Anxiety Anxiety Disorders Behavior Behavioral Symptoms Combat Disorders Depression Mental Disorders PTSD Psychological Trauma Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Following screening and consenting processes, patients will be randomized to enroll in interventional or control groups. The interventional group will listen to an audio recording of psychological support based on positive suggestion for about 30 min each day via headphones. At the time of ICU discharge, patients will be administered validated questionnaires to screen for symptoms of anxiety/depression (HADS), PTSD (IES-r), cognitive dysfunction (MOCA-blind), as well as evaluation of health status (EQ-5D). Six months post ICU discharge, patients will again be contacted and repeat the assessment with above questionnaires. Scores on the questionnaires will be compared between the groups at the two times points. Patient demographic data will also be obtained and assessed to contextualize study findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other

Daily administration of audiorecording

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS) - Anxiety

    Time frame: within 96 hours of ICU discharge

    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

Secondary outcomes

  1. Impact of Events Scale-Revised

    Time frame: within 96 hours of ICU discharge

    A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7

  2. Montreal Cognitive Assessment-Blind (MoCA-blind)

    Time frame: within 96 hours of ICU discharge

    A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1

  3. EQ-5D

    Time frame: within 96 hours of ICU discharge

    A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1

  4. Hospital Anxiety and Depression Scale (HADS) - Depression

    Time frame: within 96 hours of ICU discharge

    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

  5. Hospital Anxiety and Depression Scale (HADS) - Depression

    Time frame: 6 months following ICU discharge

    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

  6. Hospital Anxiety and Depression Scale (HADS) - Anxiety

    Time frame: 6 months following ICU discharge

    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

  7. Impact of Events Scale-Revised

    Time frame: 6 months following ICU discharge

    A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7

  8. Montreal Cognitive Assessment-Blind (MoCA-blind)

    Time frame: 6 months following ICU discharge

    A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1

  9. EQ-5D

    Time frame: 6 months following ICU discharge

    A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.