Clinical trial NCT04437095: Positive Suggestions Via MP3 Messages
Official title: Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Intensive Care Unit Syndrome
Psychological Trauma
Anxiety
Depression
PTSD
Keywords: Post traumatic stress syndrome
Anxiety
Depression
PICS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety
timeFrame: within 96 hours of ICU discharge
Secondary outcomes:
measure: Impact of Events Scale-Revised
timeFrame: within 96 hours of ICU discharge
measure: Montreal Cognitive Assessment-Blind (MoCA-blind)
timeFrame: within 96 hours of ICU discharge
measure: EQ-5D
timeFrame: within 96 hours of ICU discharge
measure: Hospital Anxiety and Depression Scale (HADS) - Depression
timeFrame: within 96 hours of ICU discharge
measure: Hospital Anxiety and Depression Scale (HADS) - Depression
timeFrame: 6 months following ICU discharge
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety
timeFrame: 6 months following ICU discharge
measure: Impact of Events Scale-Revised
timeFrame: 6 months following ICU discharge
measure: Montreal Cognitive Assessment-Blind (MoCA-blind)
timeFrame: 6 months following ICU discharge
measure: EQ-5D
timeFrame: 6 months following ICU discharge
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lioudmila Karnatovskaia, MD
role: PRINCIPAL_INVESTIGATOR
References: