Post Intensive Care Unit SyndromeNCT04437095
Positive Suggestions Via MP3 Messages
A study testing Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message in people with Post Intensive Care Unit Syndrome and Psychological Trauma, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Unit Syndrome, Psychological Trauma, Anxiety
- What is being tested?
- Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute respiratory failure and/or requiring vasopressors
- Admitted to the ICU
- Expected to stay >48 hours in the ICU
Who cannot join
- 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
Show all 10Show fewer
- Patients on comfort care
- Patients not expected to survive the hospital stay
- Those with hearing impairment
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message
- Keywords
- Post traumatic stress syndrome, Anxiety, Depression, PICS
- Medical subject headings
- Psychological Trauma, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 messageOther
Daily administration of audiorecording
| Study group | Role | What they receive |
|---|---|---|
| PSBPS Audiorecording | Experimental | Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones Receives: Other: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 96 hours of ICU discharge
Secondary outcomes (9)
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
Measured: within 96 hours of ICU discharge
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
Measured: within 96 hours of ICU discharge
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
Measured: within 96 hours of ICU discharge
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
Measured: within 96 hours of ICU discharge
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
Measured: 6 months following ICU discharge
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
Measured: 6 months following ICU discharge
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
Measured: 6 months following ICU discharge
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
Measured: 6 months following ICU discharge
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
Measured: 6 months following ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start17 Aug 2020
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 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.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lioudmila Karnatovskaia, Mayo Clinic
- Investigators
- Lioudmila Karnatovskaia, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437095
- Sponsor's protocol ID
- 20-003735
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT04437095
- Acronym / sponsor ID
- 20-003735
- Keywords
- Post traumatic stress syndrome, Anxiety, Depression, PICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| PSBPS Audiorecording | Experimental | Other: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 messageThirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute respiratory failure and/or requiring vasopressors
- Admitted to the ICU
- Expected to stay >48 hours in the ICU
Key exclusion criteria (10 listed)
- History of dementia
- History of mental retardation
- History of suicide attempt
- History of psychotic disorders such as schizophrenia
- Acute alcohol/substance intoxication or withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 messageDaily administration of audiorecording | Other | PSBPS Audiorecording |
Primary outcome
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
9 secondary outcomes
Impact of Events Scale-Revised
Time frame: within 96 hours of ICU discharge
Montreal Cognitive Assessment-Blind (MoCA-blind)
Time frame: within 96 hours of ICU discharge
EQ-5D
Time frame: within 96 hours of ICU discharge
Hospital Anxiety and Depression Scale (HADS) - Depression
Time frame: within 96 hours of ICU discharge
Hospital Anxiety and Depression Scale (HADS) - Depression
Time frame: 6 months following ICU discharge
Hospital Anxiety and Depression Scale (HADS) - Anxiety
Time frame: 6 months following ICU discharge
Impact of Events Scale-Revised
Time frame: 6 months following ICU discharge
Montreal Cognitive Assessment-Blind (MoCA-blind)
Time frame: 6 months following ICU discharge
EQ-5D
Time frame: 6 months following ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lioudmila Karnatovskaia, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message in people with Post Intensive Care Unit Syndrome and Psychological Trauma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) - Anxiety (time frame: within 96 hours of ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.