Behavioral Health Collaborative Care Model in an ICU Recovery Clinic

NCT07372586 | Recruiting

• 1 other identifier: Pro00145295
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PICS; Anxiety; Depression - Major Depressive Disorder; Post-Traumatic Stress; PTSD; Critical Illness Recovery; Critical Illness; Collaborative Care; Behavioral Health Concerns

Keywords

critical illness; post-ICU; PICS; anxiety; depression; PTSD; collaborative care model; behavioral health

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Attention Control

Interventional

EXPERIMENTAL

Behavioral: Behavioral Health Collaborative Care Model

Interventions

Behavioral Health Collaborative Care Model BEHAVIORAL

behavioral health collaborative care model in ICU recovery patients and families

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Critical Illness; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Rita Bakhru, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Bakhru, MD

CONTACT

8437924148; bakhru@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)