Clinical trial NCT06071858: Enhanced Coordinated Specialty Care for Early Psychosis
Official title: Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
Schizoaffective Disorder
Psychosis Nos/Other
Bipolar Disorder
Keywords: first episode psychosis
early psychosis
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Boston Medical Center
name: Cambridge Health Alliance
name: University of Massachusetts, Worcester
name: National Institute of Mental Health (NIMH)
First posted: 2023-10-10
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:

• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?

Participants will either:

* Receive care as usual (CSC) or
* Receive care as usual (CSC) plus five additional care elements (CSC 2.0):

  1. Individual peer support
  2. Digital outreach
  3. Care coordination
  4. Multi-family group therapy
  5. Cognitive remediation

Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.


Eligibility criteria: Inclusion Criteria:

* People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:
* McLean Hospital OnTrack (OnTrack Clinic)
* Massachusetts General Hospital (FEPP Clinic)
* Boston Medical Center (WRAP Clinic)
* Cambridge Health Alliance (RISE Clinic)
* UMass Memorial Health Care (STEP Clinic)
* ServiceNet (PREP West)

Exclusion Criteria:

* None

Primary outcomes:
measure: Months Engaged in Care
timeFrame: 12 months following clinic intake
Secondary outcomes:
measure: Clinic Visit Number
timeFrame: 12 months following clinic intake
measure: Clinic Visit Type
timeFrame: 12 months following clinic intake
measure: Duration of Treatment
timeFrame: Up to 12 months - measured as time between clinic intake and detachment
measure: Proportion in Arm Still in Clinic
timeFrame: 12 months following clinic intake
Other outcomes:
measure: Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)
timeFrame: 12 months following clinic intake
measure: Proportion of Early Detachment
timeFrame: 1 month
measure: Months Engaged in Care - extension of primary outcome
timeFrame: 24 months
Locations:
city: Belmont
country: United States
facility: McLean Hospital OnTrack Clinic
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital FEPP Clinic
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center WRAP
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Health Alliance RISE Clinic
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Community Healthlink STEP Clinic
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Dost Ongur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: