Mathison Centre for Research and Education, University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
NCT Number: NCT04829292
The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months
This study is active but is not currently recruiting participants.
Notify Me12 year–30 year
All sexes
Interventional
Not applicable
Calgary, Alberta, T2N 4Z6, Canada
In treating youth at clinical high risk of developing psychosis we have not been able to address what treatment to offer first and when to offer more intense and, ultimately, more costly treatments. The goals of achieving Precision Health objectives require that these questions be addressed through research.
The overall aim is to determine the most effective and efficient way to offer active and maintenance treatment resources for CHR youth. The first step would be to offer a range of treatments starting with the most benign as advocated in the McGorry and Hickie stage model. We will use this project to test whether clinical staging will improve prediction of prognosis and result in improved matching of treatment. The specific objectives of this project are: (1) to determine which and what proportion of participants would remit (i) within the first 1-2 months of treatment, (ii) after a brief supportive therapy, (iii) after longer term, focused psychological interventions such as CBT, CBSST and family intervention and (iv) how many make use of medications; (2) to determine adherence of CHR individuals to different treatments; and (3) to determine the need for maintenance treatment. To assess these objectives the following outcomes will be determined:
Participants will be between ages 12 and 30. We will recruit 60 participants who meet well-established criteria for clinical high risk for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS).
Assessments will be conducted at baseline and 2, 6, 12, and 18 months after baseline. Assessments consist of clinical assessments. Clinical raters will be experienced raters and will be trained on all clinical measures and routine reliability checks will be conducted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In this open trial participants are first offered supportive therapy followed by CBT
Time frame: Baseline and 18 months
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Time frame: Baseline and 18 months
Clinical rating scales to assess if there are changes in social and role functioning.
University of Calgary
Other
A Framework for Research in Emerging Adults: Stepped Care for Youth at Risk of Psychosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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