About this trial
Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
ICU Admission was due to a primary addiction diagnosis (eg alcohol withdrawal or delirium tremens requiring ICU care)
Serious Mental Illness such as Schizophrenia, psychotic disorder, acute mania
Late Stage Dementia or Cognitive Impairment
Limited English or Spanish Proficiency
Trial design
Parallel
Treatments tested in this trial
Behavioral Health Collaborative Care Model
Behavioralbehavioral health collaborative care model in ICU recovery patients and families
Treatment groups
Trial outcomes
Primary outcomes
Depression
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of depression (PHQ-9: Patient Health Questionnaire-9).
Anxiety
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of anxiety (GAD-7: Generalized Anxiety Disorder 7)
Post-Traumatic Stress
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of post-traumatic stress (PCL-5:Patient Health Questionnaire-9).
Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
Health Resources and Services Administration (HRSA)
Collaborator