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

Trial Summary

What is the purpose of this trial?

This is a dissemination and implementation study that is evaluating a stepped-care intervention for identifying and treating youths at clinical high-risk for psychosis within multiple community mental health centers.

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 data supports the effectiveness of the Stepped-Care treatment for psychosis?

Research shows that Cognitive Behavioral Therapy for psychosis (CBTp) is effective and recommended by treatment guidelines, but access is limited. The stepped-care model, which has been successful in other settings, can improve access to CBTp by using a team approach in community mental health settings. Additionally, case management combined with CBT has shown to improve outcomes for patients with severe mental illness. ^{1 2 3 4 5}

Is the Stepped-Care Program for Psychosis safe for humans?

There is limited information on the safety of behavioral health interventions like the Stepped-Care Program for Psychosis, as adverse events are often not fully monitored or reported in these trials. However, serious adverse events such as suicide attempts and psychiatric hospitalizations are typically monitored, while temporary increases in anxiety may occur but are often considered a normal part of therapy. ^{6 7 8 9 10}

How is the Stepped-Care Program for Psychosis different from other treatments for psychosis?

The Stepped-Care Program for Psychosis is unique because it uses a tiered approach to deliver Cognitive Behavioral Therapy (CBT) for psychosis, making it more accessible by starting with low-intensity interventions and increasing intensity as needed. This model leverages a multidisciplinary team to efficiently meet patient needs while maintaining high-quality care, which is not commonly available in standard treatments. ^{1 3 4 11 12}

Eligibility Criteria

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

I am between 12 and 25 years old.

Receiving care in one of six identified community mental health clinics

Eligibility for Sacramento County Medicare

Exclusion Criteria

Urgent clinical need for a higher level of care

I have an intellectual disability with an IQ below 70.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2018]

2. Switzerland 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Stepped Care as an Implementation and Service Delivery Model for Cognitive Behavioral Therapy for Psychosis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Sequential mixed method evaluation of the acceptability, feasibility, and appropriateness of cognitive behavioral therapy for psychosis stepped care. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Therapy in Intensive Case Management: A Multimethod Quantitative-Qualitative Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Safety Signal Assessment of Hospitalization Associated With the Use of Atypical Antipsychotics. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. Australia pubmed.ncbi.nlm.nih.gov

Stepping through treatment: reflections on an adaptive treatment strategy among methamphetamine users with depression. [2022]