Enhanced Coordinated Specialty Care for Early Psychosis

Mass General Brigham

Status: Enrolling

Conditions: Schizophrenia; Psychosis; Bipolar Disorder; Psychosis Nos/Other; Schizoaffective Disorder

Treatments: Behavioral: Care Coordination; Behavioral: Individual Peer Support; Behavioral: Digital Outreach; Behavioral: Multi-Family Group Therapy; Behavioral: Cognitive Remediation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06071858

2023P002612

2P50MH115846-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Coordinated Specialty Care (CSC; standard of care)

No Intervention group

Description:

Care as usual; no intervention.

Enhanced Coordinated Speciality Care (CSC 2.0)

Experimental group

Description:

CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).

Treatment:

Behavioral: Cognitive Remediation

Behavioral: Multi-Family Group Therapy

Behavioral: Digital Outreach

Behavioral: Individual Peer Support

Behavioral: Care Coordination