PICSBeColMNCT07372586
Behavioral Health Collaborative Care Model in an ICU Recovery Clinic
A study testing Behavioral Health Collaborative Care Model in people with PICS and Anxiety, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PICS, Anxiety, Depression - Major Depressive Disorder
- What is being tested?
- Behavioral Health Collaborative Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29407
Dr. Bakhru, 8437924148, bakhru@musc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- PICS, Anxiety, Depression - Major Depressive Disorder, Post-Traumatic Stress, PTSD, Critical Illness Recovery
- Being tested
- Behavioral Health Collaborative Care Model
- Keywords
- critical illness, post-ICU, PICS, anxiety, depression, PTSD, collaborative care model, behavioral health
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Critical Illness, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Health Collaborative Care ModelBehavioural
behavioral health collaborative care model in ICU recovery patients and families
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Attention Control |
| Interventional | Experimental | Not described Receives: Behavioral: Behavioral Health Collaborative Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: enrollment to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start30 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PICSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Rita Bakhru, Medical University of South Carolina
- Investigators
- Rita Bakhru, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372586
- Sponsor's protocol ID
- Pro00145295
- Acronym
- BeColM
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No