- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437095
Positive Suggestions Via MP3 Messages
March 12, 2024 updated by: Lioudmila Karnatovskaia, Mayo Clinic
Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lioudmila V Karnatovskaia, MD
- Phone Number: 507 284-2511
- Email: Karnatovskaia.Lioudmila@mayo.edu
Study Contact Backup
- Name: Kimberly R Johnson, MD
- Phone Number: 507 284-2511
- Email: johnson.kimberly5@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Standard of care
|
|
Experimental: PSBPS Audiorecording
Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones
|
Daily administration of audiorecording
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 96 hours of ICU discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 96 hours of ICU discharge
|
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
|
within 96 hours of ICU discharge
|
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
|
within 96 hours of ICU discharge
|
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
|
within 96 hours of ICU discharge
|
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 months following ICU discharge
|
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
|
6 months following ICU discharge
|
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
|
6 months following ICU discharge
|
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
|
6 months following ICU discharge
|
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
|
6 months following ICU discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lioudmila Karnatovskaia, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2020
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
June 17, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-003735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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