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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Attention Control | |
| Interventional | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Health Collaborative Care Model | Behavioral | behavioral health collaborative care model in ICU recovery patients and families |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Enrollment to 6 months |
| 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) | enrollment to six months |
| 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). | enrollment to six months |
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Inclusion Criteria:
- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rita Bakhru, MD | Contact | 8437924148 | bakhru@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rita Bakhru, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29407 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D016638 | Critical Illness |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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