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Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot

Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic-Pilot for Families

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07390786
Enrollment
150
Registered
2026-02-05
Start date
2026-01-30
Completion date
2028-06-30
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Behavioral Health Concerns, Critical Care, Intensive Care, Critical Illness Recovery, Depression - Major Depressive Disorder, PICS-F, PTSD

Keywords

Critical Ilness, critical care recovery, Post-Intensive Care Syndrome, Post-ICU care, behavioral health, mental health, anxiety, depression, PTSD, PICS-F

Brief 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. 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.

Interventions

BEHAVIORALBehavioral Treatment

behavioral health collaborative care model in ICU recovery patients and families

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
Health Resources and Services Administration (HRSA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Family member of ICU Recovery Clinic patient enrolled in parent BH CoCM study

Exclusion criteria

* Serious mental illness (e.g., schizophrenia, mania) * Late-stage dementia or cognitive impairment * Limited English proficiency * No internet-enabled device * Prisoners

Design outcomes

Primary

MeasureTime frameDescription
Consent RateBaselineInvestigators will assess the consent rate
Study Completion Rateenrollment to 6 monthsWe will assess the completion rate of all enrolled family members

Secondary

MeasureTime frameDescription
Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)Enrollment to 6 monthsRate of completion of scheduled monthly assessment: PHQ9
Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)baseline to 6 monthsRate of completion of scheduled monthly assessment: GAD7
Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5)baseline to 6 monthsRate of Completion of scheduled monthly assessment: PCL5

Countries

United States

Contacts

CONTACTRita Bakhru, MD
recruitment@musc.edu8437920965
PRINCIPAL_INVESTIGATORRita Bakhru, MD

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026