Behavioral Health Collaborative Care Model in an ICU Recovery Clinic (BeColM)

Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Critical Illness; Anxiety; Collaborative Care; PICS; Depression - Major Depressive Disorder; Behavioral Health Concerns; Critical Illness Recovery; Post-Traumatic Stress
• Intervention / Treatment: Behavioral: Behavioral Health Collaborative Care Model

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rita Bakhru, MD; Phone Number: 8437924148; Email: bakhru@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Recruiting
      • Medical University of South Carolina
      • Contact: Dr. Bakhru; Phone Number: 8437924148; Email: bakhru@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional	Behavioral: Behavioral Health Collaborative Care Model; behavioral health collaborative care model in ICU recovery patients and families
No Intervention: Control; Attention Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Rita Bakhru, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; depression; anxiety; critical illness; behavioral health; PICS; post-ICU; collaborative care model
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Disease Attributes; Behavioral Symptoms; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Behavior; Anxiety Disorders; Depression; Critical Illness; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Pro00145295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No