Intensive Care Unit (ICU) Diary Project
- Conditions
- PTSDPost ICU Syndrome
- Interventions
- Other: PTSD psycho-education aloneOther: Diary (blank journal) plus PTSD psycho-education
- Registration Number
- NCT04305353
- Lead Sponsor
- Tulane University School of Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- admitted to the intensive care unit for at least 72 hours
- sedated and mechanically ventilated for at least 24 hours.
- available over-the-phone, up to 6 months post-ICU discharge
- any patients who do not voluntarily agree to participate
- not fluent in the English language
- patients who have stayed in the ICU for less than 72 hours
- patients who have been sedated and mechanically ventilated for less than 24 hours
- patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
- patients with no phone number or reliable contact information for the sake of follow-up
- prisoners
- pregnant patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTSD Education-only Group PTSD psycho-education alone Control Group: patients randomized to this group only receive PTSD education ICU Diary Group Diary (blank journal) plus PTSD psycho-education Patients randomized to this group receive the ICU diary, along with PTSD education ICU Diary Group PTSD psycho-education alone Patients randomized to this group receive the ICU diary, along with PTSD education
- Primary Outcome Measures
Name Time Method Change in PTSD symptoms 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.
- Secondary Outcome Measures
Name Time Method Change in Hospital-associated Depression and Anxiety symptoms 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.
Change in Depression symptoms 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.
Change in Anxiety symptoms 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.
Trial Locations
- Locations (1)
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States