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NCT Number: NCT07390786

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

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.

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Key information

Conditions

Critical Illness Recovery Anxiety Anxiety Disorders Behavior Behavioral Health Concerns Behavioral Symptoms Critical Care, Intensive Care Depression Depression - Major Depressive Disorder Mental Disorders PICS-F PTSD Personal Satisfaction Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location status: Recruiting

Location contact

Rita Bakhru, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment

Behavioral

behavioral health collaborative care model in ICU recovery patients and families

Primary outcomes

  1. Consent Rate

    Time frame: Baseline

    Investigators will assess the consent rate

  2. Study Completion Rate

    Time frame: enrollment to 6 months

    We will assess the completion rate of all enrolled family members

Secondary outcomes

  1. Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)

    Time frame: Enrollment to 6 months

    Rate of completion of scheduled monthly assessment: PHQ9

  2. Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)

    Time frame: baseline to 6 months

    Rate of completion of scheduled monthly assessment: GAD7

  3. Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5)

    Time frame: baseline to 6 months

    Rate of Completion of scheduled monthly assessment: PCL5

Study contacts

Contact information is provided by the study sponsor or research team.

Rita Bakhru, MD

CONTACT

[email protected]

8437920965

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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