Enhanced Coordinated Specialty Care for Early Psychosis

ConditionsPsychosis Schizophrenia Schizoaffective Disorder Psychosis Nos/Other Bipolar Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorMclean Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

McLean Hospital OnTrack (OnTrack Clinic)

Massachusetts General Hospital (FEPP Clinic)

Boston Medical Center (WRAP Clinic)

Cambridge Health Alliance (RISE Clinic)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Care Coordination
Behavioral
* 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 Support
Behavioral
• 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 Outreach
Behavioral
• 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 Remediation
Behavioral
* 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 Therapy
Behavioral
* 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.

Treatment groups

350 Participants

are divided into 2 treatment groups

Group A: Coordinated Specialty Care (CSC; standard of care)No intervention 0 interventions

Group B: Enhanced Coordinated Speciality Care (CSC 2.0)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

Months Engaged in Care

Number of months each participant had ≥4 visits in a 12-month period

Time frame

12 months following clinic intake

Secondary outcomes

Clinic Visit Number

Total number of clinic visits in a 12-month period

Time frame

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

Time frame

12 months following clinic intake

Duration of Treatment

Duration of time in treatment

Time frame

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

Time frame

12 months following clinic intake

Other outcomes

Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)

Exploratory analysis of variables collected by EPINET CAB by arm

Time frame

12 months following clinic intake

Proportion of Early Detachment

Proportion of patients in each arm who detach from clinic prior to the end of their first month in care

Time frame

1 month

Months Engaged in Care - extension of primary outcome

Number of months each participant had ≥4 visits in a 24-month period

Time frame

24 months

Sponsors and contacts

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

Mclean Hospital

Lead sponsor

Massachusetts General Hospital

Collaborator

Boston Medical Center

Collaborator

Cambridge Health Alliance

Collaborator

University of Massachusetts, Worcester

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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