Behavioral Health Collaborative Care Model in an ICU Recovery Clinic

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

ICU Admission was due to a primary addiction diagnosis (eg alcohol withdrawal or delirium tremens requiring ICU care)

Serious Mental Illness such as Schizophrenia, psychotic disorder, acute mania

Late Stage Dementia or Cognitive Impairment

Limited English or Spanish Proficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Health Collaborative Care Model

    Behavioral

    behavioral health collaborative care model in ICU recovery patients and families

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depression

Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of depression (PHQ-9: Patient Health Questionnaire-9).

Time frame
Enrollment to 6 months
2

Anxiety

Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of anxiety (GAD-7: Generalized Anxiety Disorder 7)

Time frame
enrollment to six months
3

Post-Traumatic Stress

Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of post-traumatic stress (PCL-5:Patient Health Questionnaire-9).

Time frame
enrollment to six months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Health Resources and Services Administration (HRSA)

Collaborator