Phase 1
N=25
Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis
Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT04325568 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change From Baseline in Perceived Treatment Efficacy — 2.6; 1.6; 0.5; 0.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PsyGist and Clinician Manual (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Perceived Treatment Efficacy |
2.6; 1.6; 0.5; 0.5 | — |
| PRIMARY Change From Baseline in Intention to Use Treatment |
0.9; 1.0; -0.3; -0.5 | — |
| SECONDARY Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development |
-0.04; 0.0; 0.2; -0.3; -0.4; -0.3 | — |
| SECONDARY Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development |
-0.3; -0.4; 0.0; 0.0; -0.04; 0.3 | — |
| SECONDARY Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development |
-0.2; -0.4; -0.1 | — |
Summary
While great strides are being made in identifying early signs that place people at a 'high risk state' for different illness conditions, at the same time, advances are being made in the identification of genes associated with 'high-risk states'. This study proposes to develop two innovative clinical tools that could greatly facilitate dissemination of a beneficial genetic malleability framing to high-risk youth in order to encourage increased treatment engagement and uptake of healthy behaviors. The impact of genetic information assumes special importance in the 'high-risk state' because achieving the best possible outcome is more likely if individuals actively choose to engage in beneficial treatment and health-promoting behaviors.
Eligibility Criteria
Inclusion Criteria
- Male or females between the ages of 16- 30
- Current or previous COPE participant
- Identified as at clinical high risk for psychosis as defined as having at least one of the following: a)attenuated positive symptoms b)brief intermittent positive symptoms
Exclusion Criteria
- Meeting CHR via only the Genetic risk and deterioration (GRD) syndrome. If the participant meets the GRD syndrome only, the investigators exclude the rare Genetic risk + deterioration (GRD) syndrome (comprising <1% of CHR cases) because GRD requires having a 1st degree relative with any psychotic disorder, which may be linked with stronger reactions to genetic framings.
- IQ < 80
- Inability to adopt hypothetical situation
Data sourced from ClinicalTrials.gov (NCT04325568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.