Recruiting

Behavioral Health CoCM

Sponsor:

Medical University of South Carolina

Code:

NCT07390786

Conditions

Critical Illness Recovery

Behavioral Health Concerns

Anxiety

Depression - Major Depressive Disorder

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Treatment

Study Details

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.

Conditions

Critical Illness Recovery

Behavioral Health Concerns

Anxiety

Depression - Major Depressive Disorder

PTSD

Study ID

NCT07390786

Start date

Jan 30, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Attention Control.

experimental: Interventional

Interventions

Behavioral Treatment

behavioral health collaborative care model in ICU recovery patients and families

Primary outcome measure

  • Consent Rate [ Time Frame: Baseline ]
  • Study Completion Rate [ Time Frame: enrollment to 6 months ]

Central Contacts and Locations

Central contacts

Rita Bakhru, MD

8437920965recruitment@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Rita Bakhru, MD

bakhru@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-12.