Optimal Health Program for Psychosis

Overseen By Omair Husain, MBBS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychotic disorder, Intellectual disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the Optimal Health Program (OHP), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (CHR). The main aims of the studies are 1). To adapt an existing, effective, validated psychological intervention for use in young people with CHR; 2). To evaluate the acceptability of OHP and the feasibility of conducting a clinical trial of OHP in individuals with CHR; 3). To assess the preliminary efficacy of OHP in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with CHR in a single-arm exploratory clinical trial. Participants will be delivered OHP intervention over 12-weeks. Measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a psychological intervention, so it's best to discuss your medications with the trial team.

How is the Optimal Health Program treatment different from other treatments for psychosis?

The Optimal Health Program (OHP) is unique because it focuses on self-management and improving overall well-being by enhancing self-efficacy (belief in one's ability to succeed) and health literacy, rather than just addressing symptoms. It encourages patients to actively participate in their healthcare, which is different from traditional treatments that often focus primarily on medication and symptom management. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Optimal Health Program for psychosis?

The research suggests that patient-centered approaches, which include simplifying treatment plans and involving patients in decision-making, can improve outcomes for people with schizophrenia. These strategies are similar to components of the Optimal Health Program, indicating potential effectiveness in treating psychosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Omair Husain, MBBS

Principal Investigator

center of addiction and mental health

Are You a Good Fit for This Trial?

This trial is for young people aged 16-29 who are at risk of developing psychosis but haven't yet been diagnosed with a psychotic disorder. They must be able to consent to participate and have met criteria for psychosis risk in the past 3 years. Those with an IQ below 70, severe developmental disorders, or acute suicidality are not eligible.

Inclusion Criteria

I am between 16 and 29 years old.

I am mentally capable and agree to join the study.

Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) either currently or at some point in the past 3 years.

Exclusion Criteria

I have been diagnosed with a psychotic disorder like schizophrenia.

Intelligence quotient<70 and/or diagnosis of intellectual disability

Severe developmental disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Optimal Health Program (OHP) intervention to improve functioning, reduce distress, and build resiliency

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optimal Health Program

Trial Overview The Optimal Health Program (OHP), a comprehensive psychosocial support program, is being adapted for virtual delivery to help youth at clinical high risk for psychosis. The study will test its acceptability and preliminary efficacy in improving mental health outcomes over a period of 12 weeks.

How Is the Trial Designed?

Group I: treatment arm Experimental Treatment 1 Intervention

The single treatment arm will be administered optimal health program (OHP) intervention.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

New antipsychotic medications offer hope for improved outcomes in individuals with schizophrenia, focusing on recovery rather than just maintenance of symptoms.

The article presents a framework for understanding the diverse outcomes of long-term psychosis treatment, which can help in creating more effective treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an outcomes-oriented approach for the treatment of schizophrenia. Lehman, AF.[2019]

A patient-centered approach to treating schizophrenia, which includes simplifying medication regimens and involving patients in decision-making, can lead to improved clinical and functional outcomes.

Incorporating psychosocial interventions alongside medication may further enhance the effectiveness of treatment for individuals with schizophrenia, addressing their cognitive, behavioral, and emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia. Harvey, PD.[2021]

The article emphasizes the importance of effective outcome measures in clinical trials for schizophrenia treatments, particularly for atypical antipsychotics, to assess their success in alleviating symptoms and minimizing side effects.

It highlights the need to focus on patient-oriented outcomes rather than just minimizing costs, such as rehospitalization, to ensure that treatments truly benefit those living with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating clinical trial data: outcome measures. Conley, RR.[2019]

In a 10-year follow-up study of 496 individuals with first episode psychosis, only 14% achieved both symptomatic and psychosocial recovery, highlighting the challenges in long-term outcomes for this condition.

Lower severity of negative symptoms at the start of treatment and an earlier age of diagnosis were significant predictors of better recovery rates, suggesting that addressing negative symptoms may be crucial for improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of recovery in first episode psychosis: the OPUS cohort at 10 year follow-up. Austin, SF., Mors, O., Secher, RG., et al.[2016]

In a study of 53 patients with first-episode psychosis, a community-oriented treatment program led to a remarkable 70% complete remission rate and only a 20% hospital readmission rate after one year.

Patients who started treatment within six months of their first psychotic episode had even higher remission rates (82%) compared to those who started later, highlighting the importance of early intervention in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of patients with first-episode psychosis after one year of phase-specific community-oriented treatment. Malla, AK., Norman, RM., Manchanda, R., et al.[2015]

The SANUBARI program, a Malay adaptation of the Optimal Health Program, effectively improved self-efficacy in COVID-19 patients, with significant increases in General Self-Efficacy (GSE) scores observed immediately after the intervention and maintained one month later.

This virtual psychosocial intervention, conducted among 37 hospitalized COVID-19 patients, demonstrates potential as an early psychosocial support strategy to enhance mental wellbeing during the pandemic, without significant associations to socio-demographic or clinical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of virtual brief wellness based psychosocial intervention on mental wellbeing of stable hospitalised COVID-19 patients - A pilot study. Thong, KS., Seed, HF.[2021]

The Vancouver Coastal Health early psychosis intervention program effectively supports patients under 30 experiencing first-break psychosis by providing a multidisciplinary approach that includes medication, psychological therapies, and a focus on improving physical health.

The program incorporates routine metabolic health assessments and lifestyle goal development, which are crucial for addressing cardiometabolic health, and is supported by ongoing research to evaluate the impact of health coaching and pharmacogenomic factors on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving metabolic and cardiovascular health at an early psychosis intervention program in vancouver, Canada. Fredrikson, DH., Boyda, HN., Tse, L., et al.[2021]

The Ohio State University EPICENTER program implements a step-based care model for individuals at clinical high risk for psychosis, starting with low-intensity interventions to minimize side effects before progressing to more intensive treatments if necessary.

The primary goal of the evaluation is to measure the time to remission of symptoms and functional deficits in participants, with standardized assessments conducted every six months to track progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study. Breitborde, NJK., Guirgis, H., Stearns, W., et al.[2021]

The Mind-Body Well-being Initiative is a residential treatment model that integrates mental and physical health care, specifically designed for individuals with severe mental illness (SMI) who often face significant health disparities.

This initiative aims to close the 15-20 year life expectancy gap in SMI patients by addressing both their mental health and chronic physical health conditions through a comprehensive Lifestyle Medicine approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. Lalley, NA., Manger, SH., Jacka, F., et al.[2022]

This study aims to co-design a health and well-being support system for young people experiencing first-episode psychosis (FEP) by involving up to 15 service users, their support networks, and health professionals in workshops, emphasizing the importance of lived experiences in shaping effective interventions.

The co-design process will utilize various data collection methods, including expressive forms and traditional interviews, to create a system that is not only immediately applicable but also serves as a model for future participant-focused research in mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a System of Health Support for Young People Experiencing First-Episode Psychosis: Protocol for a Co-design Process. Jenkins, M., Gardiner, T., Pekepo, C., et al.[2023]

Citations

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

Developing an outcomes-oriented approach for the treatment of schizophrenia. [2019]

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

Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia. [2021]

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

Evaluating clinical trial data: outcome measures. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of recovery in first episode psychosis: the OPUS cohort at 10 year follow-up. [2016]

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

Status of patients with first-episode psychosis after one year of phase-specific community-oriented treatment. [2015]

6. Malaysia pubmed.ncbi.nlm.nih.gov

Impact of virtual brief wellness based psychosocial intervention on mental wellbeing of stable hospitalised COVID-19 patients - A pilot study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Improving metabolic and cardiovascular health at an early psychosis intervention program in vancouver, Canada. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The Ohio State University Early Psychosis Intervention Center (EPICENTER) step-based care programme for individuals at clinical high risk for psychosis: study protocol for an observational study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Developing a System of Health Support for Young People Experiencing First-Episode Psychosis: Protocol for a Co-design Process. [2023]