Bipolar Disorder, Psychosis, Psychosis Nos/Other, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
first episode psychosis, early psychosis
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.
Interventions
BEHAVIORALCare 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.
BEHAVIORALIndividual 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.
BEHAVIORALDigital 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.
BEHAVIORALCognitive 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.
BEHAVIORALMulti-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.
Sponsors
Mclean Hospital
Massachusetts General Hospital
Boston Medical Center
Cambridge Health Alliance
University of Massachusetts, Worcester
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Months Engaged in Care | 12 months following clinic intake | Number of months each participant had ≥4 visits in a 12-month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Visit Number | 12 months following clinic intake | Total number of clinic visits in a 12-month period |
| Clinic Visit Type | 12 months following clinic intake | Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period |
| Duration of Treatment | Up to 12 months - measured as time between clinic intake and detachment | Duration of time in treatment |
| Proportion in Arm Still in Clinic | 12 months following clinic intake | Proportion of patients in each arm who are still in CSC at the end of the 12-month follow-up period |
Countries
United States
Contacts
CONTACTDost Ongur, MD, PhD
CONTACTJacqueline Dow, MPH
PRINCIPAL_INVESTIGATORDost Ongur, MD, PhD
Mclean Hospital
Outcome results
None listed