Behavioral health collaborative care for people recovering after ICU
Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic
This trial will test whether a coordinated behavioral health program using a digital app, coaching, and psychiatric support helps ICU survivors reduce anxiety, depression, and PTSD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07372586 on ClinicalTrials.gov |
What this trial studies
This single-site randomized controlled trial at the Medical University of South Carolina will enroll about 150 patients seen in the MUSC ICU Recovery Clinic and randomize them to a behavioral health Collaborative Care Model (BH CoCM) or an attention control group. The BH CoCM arm receives access to the NeuroFlow digital platform for six months plus behavioral health manager–led coaching and psychiatric support as needed, while the control arm receives regular assessments only. Investigators will measure changes in symptoms of anxiety, depression, and post-traumatic stress over six months, along with adherence, implementation metrics, and types of content used in NeuroFlow. Qualitative surveys will also be used to gather patient feedback on acceptability and ways to improve the intervention.
Who should consider this trial
Good fit: Adults seen in the MUSC ICU Recovery Clinic within 180 days of hospital discharge who have regular access to a smartphone, tablet, or computer and do not have excluded serious psychiatric or cognitive conditions are ideal candidates.
Not a fit: Patients with primary ICU admissions for addiction, serious mental illness (e.g., schizophrenia, acute mania), late-stage dementia, limited English or Spanish proficiency, or no regular internet-capable device are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce symptoms of anxiety, depression, and PTSD and improve emotional recovery after critical illness.
How similar studies have performed: Collaborative Care Models have demonstrated effectiveness for depression and anxiety in other medical settings, but applying BH CoCM specifically to post-ICU recovery is relatively novel with limited prior randomized evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital Exclusion Criteria: * 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 * Lack of regular access to a computer, tablet or mobile device with internet access
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rita Bakhru, MD — Medical University of South Carolina
- Study coordinator: Rita Bakhru, MD
- Email: bakhru@musc.edu
- Phone: 8437924148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.