Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
NCT Number: NCT04305353
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New Orleans, Louisiana, 70112, United States
The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Hospital Anxiety and Depression Scale (HADS), range of 0-21 for either anxiety or depression subscores, with higher scores corresponding to worse outcomes. Scores of 0-7 are normal, 8-10 are borderline abnormal (mild depression or anxiety), and 11-21 correspond to severe symptoms of anxiety or depression.
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Patient Health Questionnaire (PHQ-8), score ranges 0-24, as higher scores correspond to worse depression symptoms. Scores of 5-10 represent mild symptoms of depression, 10-15 signal moderate symptoms, and 15-24 correspond to severe symptoms.
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Generalized Anxiety Disorder 7-item scores (GAD-7) range from 0 to 21, with higher scores corresponding to worse anxiety symptoms. Scores of 0-4 indicate minimal anxiety, 5-9 correspond to mild anxiety, 10-14 signal moderate anxiety, and 15-21 represent severe anxiety.
Tulane University School of Medicine
Other
Implementing an Intensive Care Unit (ICU) Diary Program at a Large Academic Medical Center: Results From a Randomized Control Trial Evaluating Psychological Morbidity Associated With Critical Illness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06403449
Mental Disorders, PTSD
Linxia, Gansu, China
View Trial DetailsNCT04523922
Alcohol Use Disorder, Alcohol-Related Disorders
Charleston, South Carolina, United States
View Trial DetailsNCT06868446
Mental Disorders, PTSD
Tallahassee, Florida, United States
View Trial DetailsNCT03778307
Endothelial Dysfunction, Mental Disorders
Los Angeles, California, United States
View Trial Details