Medical University of South Carolina
Charleston, South Carolina, 29407, United States
Location status: Recruiting
NCT Number: NCT07372586
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29407, United States
Location status: Recruiting
Patients seen in the MUSC ICU Recovery Clinic will be approached for consent for enrollment. Patients that consent will be randomized to an attention control group or an intervention group.
The intervention group receive BH CoCM. They will have access to NeuroFlow platform, which has been specifically designed to support delivery of a BH CoCM. They will utilize Neuroflow for 6 months. They will undergo assessments for anxiety, depression, post-traumatic stress. A behavioral manager will monitor their needs and provide behavioral health coaching and psychiatric support as needed.
The attention control group will undergo assessments for anxiety, depression, post-traumatic stress.
Investigators will look at changes over six months in intervention group compared to attention control group for patients in terms of symptoms of depression, anxiety, post-traumatic stress. Investigators will also look at adherence, BH CoCM implementation metrics, type and amount of guided content accessed in NeuroFlow. Investigators will perform qualitative surveys to understand better what patients thought about the intervention and ways in which it could be improved.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
behavioral health collaborative care model in ICU recovery patients and families
Time frame: Enrollment to 6 months
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).
Time frame: enrollment to six months
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)
Time frame: enrollment to six months
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).
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic
Acronym: BeColM
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.
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