Positive Suggestions Via MP3 Messages

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04437095
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Intensive Care Unit Syndrome; Psychological Trauma; Anxiety; Depression; PTSD	Other: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 sample size of 25 per arm provides 90% power to detect a 40% decrease in mean HADS-A, assuming a two-sided t-test with unequal variances at alpha level 0.05 and conservatively assuming a coefficient of variation of 0.6. A total 62 subjects will be enrolled and randomized to allow for 20% 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.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 sample size of 25 per arm provides 90% power to detect a 40% decrease in mean HADS-A, assuming a two-sided t-test with unequal variances at alpha level 0.05 and conservatively assuming a coefficient of variation of 0.6. A total 62 subjects will be enrolled and randomized to allow for 20% 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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes
• Actual Study Start Date: Aug 17, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PSBPS Audiorecording 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; Daily administration of audiorecording
No Intervention: Control Standard of care

Outcome Measures

Primary Outcome Measures

1. Hospital Anxiety and Depression Scale (HADS) - Anxiety [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 Outcome Measures

1. Impact of Events Scale-Revised [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) [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 [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 [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 [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 [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 [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) [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Lioudmila Karnatovskaia, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Lioudmila Karnatovskaia, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04437095
• Other Study ID Numbers: 20-003735
• First Posted: Jun 18, 2020
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lioudmila Karnatovskaia, Principal Investigator, Mayo Clinic: Post traumatic stress syndrome; Anxiety; Depression; PICS
• Additional relevant MeSH terms: Depression; Psychological Trauma

Study Results

No Results Posted as of Aug 11, 2022