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Behavioral Intervention

Optimal Health Program for Psychosis

N/A

Recruiting

Led By Omair Husain, MBBS

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post treatment (12 weeks after baseline)

Awards & highlights

Study Summary

This trial aims to reduce distress & build resilience in young people with clinical risk of psychosis, through a tailored virtual intervention program.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since OHP is a psychological intervention rather than medication, it may not have typical 'side effects' like drugs do; however, participants might experience emotional discomfort or distress as they engage with the material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post treatment (12 weeks after baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post treatment (12 weeks after baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post treatment (12 weeks after baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

Attrition

Client Satisfaction Questionnaire

+1 more

Secondary outcome measures

Calgary Depression Scale for Schizophrenia

Connor-Davidson Resilience Scale

Global Functioning: Role

+5 more

Other outcome measures

The Self-report World Health Organization - Disability Assessment Schedule (WHO-DAS 2.0)

Trial Design

1Treatment groups

Experimental Treatment

Group I: treatment armExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Optimal Health Program

2018

N/A

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,428 Total Patients Enrolled

16 Trials studying Psychosis

1,909 Patients Enrolled for Psychosis

Omair Husain, MBBSPrincipal Investigatorcenter of addiction and mental health

Media Library

Optimal Health Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05757128 — N/A

Psychosis Research Study Groups: treatment arm

Psychosis Clinical Trial 2023: Optimal Health Program Highlights & Side Effects. Trial Name: NCT05757128 — N/A

Optimal Health Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757128 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this trial limited to those under 25 years old?

"This research seeks participants aged 16 to 29 years."

Answered by AI

Is enrollment for the clinical trial still open?

"Yes, the clinicaltrial.gov records demonstrate that this experiment is actively recruiting participants. It was first made available on September 5th 2023 and has been revised most recently on August 28th 2023. 30 study volunteers are being sought from 1 medical site."

Answered by AI

How many subjects are involved in the data collection for this research?

"Verified. According to information from clinicaltrials.gov, this medical research is presently soliciting candidates; the trial was posted on September 5th 2023 and last updated on August 28th 2023. The study requires 30 participants recruited from a single site."

Answered by AI

Who is best suited to partake in this particular research initiative?

"This medical study is seeking 30 young adults between the ages of 16 and 29, who have a documented history or current diagnosis of psychosis. In addition to age-eligibility, participants must demonstrate competency in providing consent for their involvement as well as meet CHR criteria based on SIPS interviews from within the last three years."

Answered by AI

What objectives is this research endeavor attempting to fulfill?

"The primary metric of this experiment, measured 12 weeks post-baseline is patient adherence. Other evaluative parameters include psychiatric diagnoses confirmed using the Structured Clinical Interview (SCID) for DSM-5., severity ratings from the Scale Of Psychosis-risk Symptoms (SOPS), and depression scores assessed via Calgary Depression Scale for Schizophrenia which gauges nine items on a four point Likert scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

2023. "Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757128.