NCT07390786

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jun 2028

First Submitted

Initial submission to the registry

January 12, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

January 12, 2026

Last Update Submit

March 11, 2026

Conditions

Behavioral Health ConcernsAnxietyPTSDCritical Care, Intensive CarePICS-FCritical Illness RecoveryDepression - Major Depressive Disorder

Keywords

Critical Ilnesscritical care recoveryPost-Intensive Care SyndromePost-ICU carebehavioral healthmental healthanxietydepressionPTSDPICS-F

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9)

    Enrollment to 6 months

  • Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7)

    baseline to 6 months

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

    baseline to 6 months

Study Arms (2)

Control

NO INTERVENTION

Attention Control.

Interventional

EXPERIMENTAL
Behavioral: Behavioral Treatment

Interventions

Behavioral TreatmentBEHAVIORAL

behavioral health collaborative care model in ICU recovery patients and families

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersStress Disorders, Post-Traumaticpostintensive care syndromePsychological Well-BeingDepression

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersPersonal SatisfactionBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rita Bakhru, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Bakhru, MD

CONTACT

8437920965recruitment@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 5, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

De-identified data may be used for future research without additional consent.

Locations

US(1)