Critical Illness RecoveryNCT07390786
Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot
A study testing Behavioral Treatment in people with Critical Illness Recovery and Behavioral Health Concerns, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This pilot study evaluates the feasibility and acceptability of implementing a Behavioral Health Collaborative Care Model (BH CoCM) for family members of ICU survivors. The intervention includes telehealth-enabled behavioral health assessments and access to the NeuroFlow platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Recovery, Behavioral Health Concerns, Anxiety
- What is being tested?
- Behavioral Treatment
- 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
- Are there results?
- Not yet: the study is under way
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
- Family member of ICU Recovery Clinic patient enrolled in parent BH CoCM study
Who cannot join
- Serious mental illness (e.g., schizophrenia, mania)
- Late-stage dementia or cognitive impairment
- Limited English proficiency
- No internet-enabled device
- Prisoners
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
Rita Bakhru, MD, bakhru@musc.edu
About this study
Official title: Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic-Pilot for Families
This pilot study evaluates the feasibility and acceptability of implementing a Behavioral Health Collaborative Care Model (BH CoCM) for family members of ICU survivors. The intervention includes telehealth-enabled behavioral health assessments and access to the NeuroFlow platform. A subset of participants will undergo qualitative interviews.
Read the detailed description
Patients seen in the MUSC ICU Recovery Clinic will be approached for consent for care through our Behavioral Health Collaborative Care Model. Patients and their families that consent will be randomized to an attention control group or an intervention group.
The intervention group 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 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
- Critical Illness Recovery, Behavioral Health Concerns, Anxiety, Depression - Major Depressive Disorder, PTSD, Critical Care, Intensive Care
- Being tested
- Behavioral Treatment
- Keywords
- Critical Ilness, critical care recovery, Post-Intensive Care Syndrome, Post-ICU care, behavioral health, mental health, anxiety, depression, PTSD, PICS-F
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, postintensive care syndrome, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
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 Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
Investigators will assess the consent rate
Measured: Baseline
Study Completion Rate
We will assess the completion rate of all enrolled family members
Measured: enrollment to 6 months
Secondary outcomes (3)
Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)
Rate of completion of scheduled monthly assessment: PHQ9
Measured: Enrollment to 6 months
Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)
Rate of completion of scheduled monthly assessment: GAD7
Measured: baseline to 6 months
Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5)
Rate of Completion of scheduled monthly assessment: PCL5
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 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 Critical Illness RecoveryStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- NCT07390786
- Sponsor's protocol ID
- Pro00145594
- 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: De-identified data may be used for future research without additional consent.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic-Pilot for Families
- ClinicalTrials.gov ID
- NCT07390786
- Acronym / sponsor ID
- Pro00145594
- Conditions
- Critical Illness Recovery, Behavioral Health Concerns, Anxiety, Depression - Major Depressive Disorder, PTSD, Critical Care, Intensive Care
- Keywords
- Critical Ilness, critical care recovery, Post-Intensive Care Syndrome, Post-ICU care, behavioral health, mental health, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study evaluates the feasibility and acceptability of implementing a Behavioral Health Collaborative Care Model (BH CoCM) for family members of ICU survivors. The intervention includes telehealth-enabled behavioral health assessments and access to the NeuroFlow platform. A subset of participants will undergo qualitative interviews.
Detailed description
Patients seen in the MUSC ICU Recovery Clinic will be approached for consent for care through our Behavioral Health Collaborative Care Model. Patients and their families that consent will be randomized to an attention control group or an intervention group.
The intervention group 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Attention Control. |
| Interventional | Experimental | Behavioral: Behavioral Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family member of ICU Recovery Clinic patient enrolled in parent BH CoCM study
Key exclusion criteria (5 listed)
- Serious mental illness (e.g., schizophrenia, mania)
- Late-stage dementia or cognitive impairment
- Limited English proficiency
- No internet-enabled device
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Treatmentbehavioral health collaborative care model in ICU recovery patients and families | Behavioural | Interventional |
Primary outcome
Consent Rate
Time frame: Baseline
Investigators will assess the consent rate
Study Completion Rate
Time frame: enrollment to 6 months
We will assess the completion rate of all enrolled family members
3 secondary outcomes
Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)
Time frame: Enrollment to 6 months
Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)
Time frame: baseline to 6 months
Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5)
Time frame: baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No. De-identified data may be used for future research without additional consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Bakhru, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment in people with Critical Illness Recovery and Behavioral Health Concerns, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Bakhru, MD (8437920965, recruitment@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.