Recruiting

BH CoCM

Sponsor:

Medical University of South Carolina

Code:

NCT07372586

Conditions

PICS

Anxiety

Depression - Major Depressive Disorder

Post-Traumatic Stress

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Health Collaborative Care Model

Study Details

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

Study ID

NCT07372586

Start date

Jan 30, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Attention Control

experimental: Interventional

Interventions

Behavioral Health Collaborative Care Model

behavioral health collaborative care model in ICU recovery patients and families

Primary outcome measure

  • Depression [ Time Frame: Enrollment to 6 months ]
  • Anxiety [ Time Frame: enrollment to six months ]
  • Post-Traumatic Stress [ Time Frame: enrollment to six months ]

Central Contacts and Locations

Central contacts

Rita Bakhru, MD

8437924148bakhru@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Dr. Bakhru

8437924148bakhru@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-12.