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

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Not yet enrolling

Conditions

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

Treatments

Behavioral: Behavioral Health Collaborative Care Model

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT07372586
Pro00145295

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Control
No Intervention group
Description:
Attention Control
Interventional
Experimental group
Treatment:
Behavioral: Behavioral Health Collaborative Care Model

Trial contacts and locations

1

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Central trial contact

Rita Bakhru, MD

Data sourced from clinicaltrials.gov

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