RECRUITING

Enhanced Coordinated Specialty Care for Early Psychosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis

Quick Facts

Study Start:2024-02-01
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06071858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:
  2. * McLean Hospital OnTrack (OnTrack Clinic)
  3. * Massachusetts General Hospital (FEPP Clinic)
  4. * Boston Medical Center (WRAP Clinic)
  5. * Cambridge Health Alliance (RISE Clinic)
  6. * UMass Memorial Health Care (STEP Clinic)
  7. * ServiceNet (PREP West)
  1. * None

Contacts and Locations

Study Contact

Dost Ongur, MD, PhD
CONTACT
617-855-3922
dongur@mgb.org
Jacqueline Dow, MPH
CONTACT
617-855-3321
jdow@mclean.harvard.edu

Principal Investigator

Dost Ongur, MD, PhD
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital OnTrack Clinic
Belmont, Massachusetts, 02478
United States
Massachusetts General Hospital FEPP Clinic
Boston, Massachusetts, 02114
United States
Boston Medical Center WRAP
Boston, Massachusetts, 02118
United States
Cambridge Health Alliance RISE Clinic
Cambridge, Massachusetts, 02139
United States
ServiceNet PREP West
Holyoke, Massachusetts, 01040
United States
UMass Memorial Community Healthlink STEP Clinic
Worcester, Massachusetts, 01610
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

  • Dost Ongur, MD, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • first episode psychosis
  • early psychosis

Additional Relevant MeSH Terms

  • Psychosis
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis Nos/Other
  • Bipolar Disorder