Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-30
SponsorIcahn School of Medicine at Mount Sinai

About this trial

The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 12- 30

ability to participate in assessments in English or Spanish

ability to provide informed consent (assent for those under age 18)

Disqualifiers

previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Screening Method (SM)

    Behavioral

    All consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate.

  • Screening and Communication Method (SCM)

    Behavioral

    Clinicians will be trained to discuss findings and provide referrals using the ComPsych model. ComPsych prepares clinicians to effectively communicate diagnostic, prognostic and treatment information about FEP and CHR with patients and families, using a model that instils realistic hope and provides information effectively to encourage shared decision making about treatment. All consecutive patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Following the evaluation, the clinician will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty services, as appropriate.

Treatment groups

912 Participants
are divided into 2 treatment groups
Group A: Screening Method (SM)Active comparator 1 intervention
Group B: Screening and Communication Method (SCM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of untreated psychosis (DUP)

The DUP is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and initiation of FEP treatment (date of intake into Coordinated Specialty Care (CSC) programs for first episode psychosis.

Time frame
up to 2 years

Secondary outcomes

1

Duration of unrecognized illness (DUI)

The DUI is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and evaluation with the SIPS.

Time frame
Baseline
2

Number of individuals initiating FEP services

Number of individuals initiating FEP services

Time frame
up to 4 years
3

Number of individuals initiating CHR services

Number of individuals initiating CHR services

Time frame
up to 4 years
4

Patient Satisfaction with Consultation Questionnaire (PSC)

This 22-item measure uses a 5-point Likert scale to measure satisfaction with amount/quality of information presented, emotional support and level of patient and family participation. The PSC has high internal reliability (Cronbach's Alpha .91). Used extensively in cancer studies, it is sensitive to differences in consultant behavior. For the purposes of this study, 4 items were removed. PSC will be administered to patients and family members in both SCM and SM conditions after a consultation where SIPS feedback is provided and referral made (in SCM ComPsych model will be used). Full scale from 18 - 90, with higher score indicating greater satisfaction

Time frame
Month 1

Other outcomes

Sponsors and contacts

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Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator