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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Anxiety; Critical Care, Intensive Care; Depression - Major Depressive Disorder; Behavioral Health Concerns; Critical Illness Recovery; PICS-F
• Intervention / Treatment: Behavioral: Behavioral Treatment

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rita Bakhru, MD; Phone Number: 8437920965; Email: recruitment@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Recruiting
      • Medical University of South Carolina
      • Contact: Rita Bakhru, MD; Email: bakhru@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional	Behavioral: Behavioral Treatment; behavioral health collaborative care model in ICU recovery patients and families
No Intervention: Control; Attention Control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent Rate	Investigators will assess the consent rate	Baseline
Study Completion Rate	We will assess the completion rate of all enrolled family members	enrollment to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)	Rate of completion of scheduled monthly assessment: PHQ9	Enrollment to 6 months
Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)	Rate of completion of scheduled monthly assessment: GAD7	baseline to 6 months
Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5)	Rate of Completion of scheduled monthly assessment: PCL5	baseline to 6 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Rita Bakhru, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; depression; mental health; anxiety; Post-Intensive Care Syndrome; behavioral health; PICS-F; Critical Ilness; critical care recovery; Post-ICU care
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Psychological Well-Being; postintensive care syndrome; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: Pro00145594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data may be used for future research without additional consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No