Stepped-Care Program for Psychosis

(SCIP Step Trial)

Recruiting at 5 trial locations

Overseen By Maria Pagador

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Intellectual disability, Urgent clinical need

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

223 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stepped-care program designed to assist young people at high risk for developing psychosis, including conditions like hearing voices or having unusual thoughts. The program offers different levels of care and employs Cognitive Behavioral Case Management for personalized support. Participants will undergo assessments every six months, with care adjustments based on their needs. The trial seeks participants aged 12 to 25 who are already receiving care at specific mental health clinics and have been identified as high risk for psychosis. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for young individuals at risk.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this stepped-care intervention is safe for youths at clinical high-risk for psychosis?

Previous studies have shown that the Stepped-Care Program for Psychosis, which includes Cognitive Behavioral Case Management, helps people at high risk for psychosis. However, detailed information about the program's safety is limited. Programs like this typically have few unwanted side effects, suggesting they are generally safe. This treatment aims to help young people early to prevent or reduce the impact of psychosis. Although more detailed safety information would be beneficial, these programs are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepped-Care Program for Psychosis because it offers a personalized treatment path for youths at high risk of developing psychosis. Unlike standard treatments, which often rely on medication or static therapy routines, this approach adapts over time, providing increasing levels of support only when needed. This dynamic method allows for early intervention and precise adjustment to each individual's progress, aiming to prevent full-blown psychosis while minimizing unnecessary treatment exposure. By focusing on Cognitive Behavioral Case Management, the program blends therapeutic intervention with case management, potentially offering a more comprehensive and proactive approach compared to existing options.

What evidence suggests that the Stepped-Care Intervention might be an effective treatment for psychosis?

Research has shown that a stepped-care approach, which includes Cognitive Behavioral Case Management, can help individuals at high risk for developing psychosis. This trial will evaluate the effectiveness of this approach. Studies have found that these methods can delay or even prevent the onset of full psychosis. Specifically, one study found that participants who received stepped-care interventions had better outcomes and were less likely to develop psychosis compared to those who did not receive this care. Cognitive Behavioral Therapy, a key part of this treatment, is known to help manage symptoms and is recommended in treatment guidelines. These findings suggest that the stepped-care approach could be beneficial for young people at high risk for psychosis. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for young people who might be at high risk of developing psychosis. It's being conducted in community mental health centers and aims to identify and help these individuals early on.

Inclusion Criteria

Receiving care in one of six identified community mental health clinics

Eligibility for Sacramento County Medicare

I am between 12 and 25 years old.

Exclusion Criteria

Urgent clinical need for a higher level of care

I have an intellectual disability with an IQ below 70.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Stepped-Care Intervention

Participants identified with a clinical high risk for psychosis begin a 2-year, 6-step intervention, assessed every 6 months.

24 months

5 visits (in-person) every 6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at 6-month intervals.

6 months

1 visit (in-person)

Open-label extension (optional)

Participants may continue treatment at the early psychosis specialty clinic if they still meet CHRp criteria or develop psychosis.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Stepped-Care including Cognitive Behavioral Case Management

Trial Overview The study is testing a 'stepped-care' approach, which means care intensity increases based on need. It includes Cognitive Behavioral Case Management designed to support youths at risk for psychosis.

How Is the Trial Designed?

Group I: Cognitive Behavioral Case Management Experimental Treatment 1 Intervention

Once youths are identified with a clinical high risk for psychosis (CHRp) syndrome they will begin a 2-year, 6 step intervention. They will be assessed every 6 months. If youths continue to meet CHRp criteria they will move into the next step. If they no longer meet criteria they exit the study and resume standard care. If they develop psychosis or reach the end of the 2-year intervention they can move to EDAPT, a psychosis specialty clinic or work with personnel to find a more appropriate clinical service.

Stepped-Care including Cognitive Behavioral Case Management is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Case Management for:

• Psychosis risk management
• Mental health support

Approved in European Union as Stepped-Care Intervention for:

• Early psychosis intervention
• Mental health prevention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Sacramento County Behavioral Health Services

Collaborator

Trials

1

Recruited

220+

Published Research Related to This Trial

The pilot trial involving 18 participants showed that a stepped-care approach, which included cognitive behavior therapy and motivational interventions, led to improvements in both depression and methamphetamine use among users with moderate depressive symptoms.

While the adaptive treatment model demonstrated positive outcomes, it did not provide a more efficient delivery of psychological treatment compared to a fixed treatment approach, indicating a need for specific training in implementing stepped-care strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping through treatment: reflections on an adaptive treatment strategy among methamphetamine users with depression. Kay-Lambkin, FJ., Baker, AL., McKetin, R., et al.[2022]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

The study involved six clients with schizophrenia who underwent ten sessions of Cognitive Behavioral Therapy for psychosis (CBT-p), comparing those who received low-intensity case management with those who received standard case management.

Findings suggest that the type of case management received may influence client engagement and progress in psychotherapy, highlighting the potential benefits of integrating low-intensity interventions with standard therapy approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Psychosis (CBT-p) Delivered in a Community Mental Health Setting: A Case Comparison of Clients Receiving CBT Informed Strategies by Case Managers Prior to Therapy. Sivec, HJ., Montesano, VL., Skubby, D., et al.[2018]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

Cognitive behavioral therapy (CBT) is an effective, evidence-based treatment for schizophrenia spectrum disorders, yet only 0.3% of individuals with primary psychotic disorders in the U.S. currently have access to it.

The paper proposes using a stepped care model to improve access to CBT for psychosis in community mental health settings, which could enhance treatment delivery by utilizing a multidisciplinary team approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped Care as an Implementation and Service Delivery Model for Cognitive Behavioral Therapy for Psychosis. Kopelovich, SL., Strachan, E., Sivec, H., et al.[2020]

A study analyzing 204,287 hospitalization cases linked to atypical antipsychotics (AAPs) found significant safety signals for clozapine, olanzapine, quetiapine, risperidone, aripiprazole, and ziprasidone, indicating these medications are associated with a higher likelihood of hospitalization due to adverse events.

No safety signals were identified for paliperidone, pimavanserin, iloperidone, asenapine, lurasidone, and brexpiprazole, suggesting these AAPs may have a better safety profile regarding hospitalization risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety Signal Assessment of Hospitalization Associated With the Use of Atypical Antipsychotics. Yunusa, I., Teng, C., Karaye, IM., et al.[2022]

A stepped care approach to treating alcohol problems focuses on individualized treatment plans that are based on research and clinical judgment, ensuring that care is both effective and tailored to the client's needs.

This method prioritizes efficiency and quality, aiming to provide the least restrictive treatment options that are still likely to succeed, which can improve overall outcomes in alcohol treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care as a heuristic approach to the treatment of alcohol problems. Sobell, MB., Sobell, LC.[2022]

A study involving 46 practitioners trained in a stepped care model for Cognitive Behavioral Therapy for psychosis (CBTp-SC) found that they viewed the model as highly acceptable, feasible, and appropriate for community mental health settings.

Focus groups revealed that while practitioners support the stepped care approach, they also identified barriers to implementation, such as the need for organizational readiness and a dedicated CBTp coordinator, which are crucial for refining the model in U.S. public behavioral health agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential mixed method evaluation of the acceptability, feasibility, and appropriateness of cognitive behavioral therapy for psychosis stepped care. Kopelovich, SL., Maura, J., Blank, J., et al.[2022]

Patients with severe schizophrenia in a community-based case-managed program (CMP) showed significantly higher treatment adherence and better clinical outcomes compared to those receiving standard treatment, as observed in a ten-year follow-up study of 688 patients.

The use of long-acting injectable (LAI) antipsychotic medications in the CMP was associated with fewer hospitalizations and suicide attempts, indicating that this approach may enhance treatment effectiveness over traditional oral antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of More Personalized, Case-Managed, and Multicomponent Treatment for Patients with Severe Schizophrenia Compared to the Standard Treatment: A Ten-Year Follow-Up. Fernández-Miranda, JJ., Díaz-Fernández, S., López-Muñoz, F.[2023]

A 90-week study involving 40 patients showed that cognitive-behavioral therapy (CBT) implemented by intensive case management (ICM) teams significantly reduced negative symptoms in patients with severe mental illness compared to those receiving treatment as usual (TAU).

The study highlights that CBT can be effectively integrated into ICM settings, providing a promising approach to improve access to this therapy for individuals with schizophrenia and other severe mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Therapy in Intensive Case Management: A Multimethod Quantitative-Qualitative Study. Jetté Pomerleau, V., Demoustier, A., Krajden, RV., et al.[2023]

Citations

1. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.20240505

Stepped Care Interventions for Psychosis Risk This study used secondary analysis of National Outcome Measures assessment data collected from 1,071 clients served by CHR-P grantee programs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7700893/

Real-world long-term outcomes in individuals at clinical ... This study determines the real-world and long-term clinical outcomes beyond transition to psychosis in a large cohort of CHR-P individuals.

3. authorea.com authorea.com/users/932386/articles/1303189-feasibility-of-a-stepped-care-intervention-for-those-at-clinical-high-risk-for-psychosis-in-the-united-states

Feasibility of a stepped-care intervention for those at ... This study assessed feasibility of a stepped-care model for those at clinical high-risk for psychosis (CHRp) within a coordinated specialty care clinic in the ...

4. researchgate.net researchgate.net/publication/397343817_Stepped_Care_Interventions_for_Psychosis_Risk_Findings_From_Clinical_High_Risk_for_Psychosis_Grantee_Programs

Findings From Clinical High Risk for Psychosis Grantee ... Objectives To examine the association between exposure to greenness and hospital admissions for mental disorders, and to estimate greenness ...

5. withpower.com withpower.com/trial/phase-mental-disorders-2-2023-3c7ef

Stepped-Care Program for Psychosis (SCIP Step Trial) Research shows that Cognitive Behavioral Therapy for psychosis (CBTp) is effective and recommended by treatment guidelines, but access is limited. The stepped- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41194658/

Findings From Clinical High Risk for Psychosis Grantee ... Findings offer preliminary evidence that CHR-P grantee programs are beneficial across several key client outcomes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876201824002351

Clinical High-Risk for Psychosis (CHR-P) circa 2024 CHR-P identifies young individuals in early stages of psychosis, aiding rapid intervention to prevent or mitigate its impact. •. CHR-P treatment guidelines ...