Positive Suggestions Via MP3 Messages

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04437095
• Other study ID #: 20-003735
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Lioudmila V Karnatovskaia, MD
• Phone: 507 284-2511
• Email: Karnatovskaia.Lioudmila[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message
Daily administration of audiorecording

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of Events Scale-Revised	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
Secondary	Montreal Cognitive Assessment-Blind (MoCA-blind)	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
Secondary	EQ-5D	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
Secondary	Hospital Anxiety and Depression Scale (HADS) - Depression	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
Secondary	Hospital Anxiety and Depression Scale (HADS) - Depression	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
Secondary	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	6 months following ICU discharge
Secondary	Impact of Events Scale-Revised	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
Secondary	Montreal Cognitive Assessment-Blind (MoCA-blind)	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
Secondary	EQ-5D	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