PsychosisNCT06071858
Enhanced Coordinated Specialty Care for Early Psychosis
A study testing Care Coordination, Individual Peer Support and Digital Outreach in people with Psychosis and Schizophrenia, run by Mclean Hospital at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychosis, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Care Coordination, Individual Peer Support and Digital Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
McLean Hospital OnTrack Clinic
Belmont, Massachusetts, 02478
Dost Ongur, MD, PhD
- Recruiting
Massachusetts General Hospital FEPP Clinic
Boston, Massachusetts, 02114
Dost Ongur, MD, PhD
- Recruiting
Boston Medical Center WRAP
Boston, Massachusetts, 02118
Dost Ongur, MD, PhD
- Recruiting
Cambridge Health Alliance RISE Clinic
Cambridge, Massachusetts, 02139
Dost Ongur, MD, PhD
- Recruiting
UMass Memorial Community Healthlink STEP Clinic
Worcester, Massachusetts, 01610
Dost Ongur, MD, PhD
About this study
Official title: Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
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?
Read more
Participants will either:
- Receive care as usual (CSC) or
- Receive care as usual (CSC) plus five additional care elements (CSC 2.0):
- Individual peer support
- Digital outreach
- Care coordination
- Multi-family group therapy
- 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.
- Being tested
- Care Coordination, Individual Peer Support, Digital Outreach, Cognitive Remediation, Multi-Family Group Therapy
- Keywords
- first episode psychosis, early psychosis
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care CoordinationBehavioural
- The study staff clinician will review all medical issues for each patient and reach out to primary care providers (PCP), dieticians, and other medical providers as needed.
- The study staff clinician will serve as point person for communication with emergency departments and inpatient providers if the patient requires those levels of care.
- The clinician will communicate with outside providers to provide background and ensure health decision making by those providers, visit and support patients as appropriate, access outside records and share with rest of the care team, and most critically ensure that a proper discharge plan has been made for the patient including care appointments, access to prescriptions and any new referrals made during hospitalization.
Individual Peer SupportBehavioural
- Patients will be offered weekly 1:1 sessions with a Peer Provider as part of routine care in a mixture of in-person and virtual formats as appropriate to support patients around treatment decisions, and recovery.
Digital OutreachBehavioural
- mindLAMP smartphone application for various kinds of outreach including but not limited to medication and/or appointment reminders, resources, and activities such as breathing and meditation exercises.
Cognitive RemediationBehavioural
- For participants identified as needing and/or wanting support around cognition.
- The cognitive remediation program is available online or in-app and offers memory, attention, processing speed, executive functioning, and social cognition training activities.
Multi-Family Group TherapyBehavioural
- Families whose loved ones are in CSC clinic will be offered weekly group sessions with a study staff clinician.
- Each group may include 5-8 families and include a mixture of in-person and virtual formats.
- These groups will be open-ended, including psychoeducation, and practical problem-solving discussions around care and other topics.
| Study group | Role | What they receive |
|---|---|---|
| Coordinated Specialty Care (CSC; standard of care) | No intervention | Care as usual; no intervention. |
| Enhanced Coordinated Speciality Care (CSC 2.0) | Experimental | CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable). Receives: Behavioral: Care Coordination; Behavioral: Individual Peer Support; Behavioral: Digital Outreach; Behavioral: Cognitive Remediation; Behavioral: Multi-Family Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Months Engaged in Care
Number of months each participant had ≥4 visits in a 12-month period
Measured: 12 months following clinic intake
Secondary outcomes (4)
Clinic Visit Number
Total number of clinic visits in a 12-month period
Measured: 12 months following clinic intake
Clinic Visit Type
Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period
Measured: 12 months following clinic intake
Duration of Treatment
Duration of time in treatment
Measured: Up to 12 months - measured as time between clinic intake and detachment
Proportion in Arm Still in Clinic
Proportion of patients in each arm who are still in CSC at the end of the 12-month follow-up period
Measured: 12 months following clinic intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Feb 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dost Ongur, Mclean Hospital
- Investigators
- Dost Ongur, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071858
- Sponsor's protocol ID
- 2023P002612
- Other IDs
- 2P50MH115846-05
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
- ClinicalTrials.gov ID
- NCT06071858
- Acronym / sponsor ID
- 2023P002612
- Keywords
- first episode psychosis, early psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Individual peer support
- Digital outreach
- Care coordination
- Multi-family group therapy
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated Specialty Care (CSC; standard of care) | No intervention | –Care as usual; no intervention. |
| Enhanced Coordinated Speciality Care (CSC 2.0) | Experimental | Behavioral: Care Coordination, Behavioral: Individual Peer Support, Behavioral: Digital Outreach, Behavioral: Cognitive Remediation, Behavioral: Multi-Family Group TherapyCSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Coordination* The study staff clinician will review all medical issues for each patient and reach out to primary care providers (PCP), dieticians, and other medical providers as needed. * The study staff clinician will serve as point person for communication with emergency departments and inpatient providers if the patient requires those levels of care. * The clinician will communicate with outside providers to provide background and ensure health decision making by those providers, visit and support patients as appropriate, access outside records and share with rest of the care team, and most critically ensure that a proper discharge plan has been made for the patient including care appointments, access to prescriptions and any new referrals made during hospitalization. | Behavioural | Enhanced Coordinated Speciality Care (CSC 2.0) |
| Individual Peer Support• Patients will be offered weekly 1:1 sessions with a Peer Provider as part of routine care in a mixture of in-person and virtual formats as appropriate to support patients around treatment decisions, and recovery. | Behavioural | Enhanced Coordinated Speciality Care (CSC 2.0) |
| Digital Outreach• mindLAMP smartphone application for various kinds of outreach including but not limited to medication and/or appointment reminders, resources, and activities such as breathing and meditation exercises. | Behavioural | Enhanced Coordinated Speciality Care (CSC 2.0) |
| Cognitive Remediation* For participants identified as needing and/or wanting support around cognition. * The cognitive remediation program is available online or in-app and offers memory, attention, processing speed, executive functioning, and social cognition training activities. | Behavioural | Enhanced Coordinated Speciality Care (CSC 2.0) |
| Multi-Family Group Therapy* Families whose loved ones are in CSC clinic will be offered weekly group sessions with a study staff clinician. * Each group may include 5-8 families and include a mixture of in-person and virtual formats. * These groups will be open-ended, including psychoeducation, and practical problem-solving discussions around care and other topics. | Behavioural | Enhanced Coordinated Speciality Care (CSC 2.0) |
Primary outcome
Months Engaged in Care
Time frame: 12 months following clinic intake
Number of months each participant had ≥4 visits in a 12-month period
4 secondary outcomes
Clinic Visit Number
Time frame: 12 months following clinic intake
Clinic Visit Type
Time frame: 12 months following clinic intake
Duration of Treatment
Time frame: Up to 12 months - measured as time between clinic intake and detachment
Proportion in Arm Still in Clinic
Time frame: 12 months following clinic intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dost Ongur, MD, PhD principal investigator
Mclean Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination, Individual Peer Support and Digital Outreach in people with Psychosis and Schizophrenia, run by Mclean Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dost Ongur, MD, PhD (617-855-3922, dongur@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Months Engaged in Care (time frame: 12 months following clinic intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.