Positive Suggestions Via MP3 Messages
- Conditions
- PTSDPsychological TraumaAnxietyDepressionPost Intensive Care Unit Syndrome
- Interventions
- Other: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message
- Registration Number
- NCT04437095
- Lead Sponsor
- Mayo Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Acute respiratory failure and/or requiring vasopressors
- Admitted to the ICU
- Expected to stay >48 hours in the ICU
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PSBPS Audiorecording Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States