NCT04325568

Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis

Completed Phase 1 Results posted Last updated 19 March 2024

What this trial tests

Phase 1 trial testing PsyGist and Clinician Manual in Psychosis in 25 participants. Completed in 31 July 2022.

Timeline

16 November 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	New York University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	16 November 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• PsyGist and Clinician Manual

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

New York University

Who can join

Adults 16 to 30, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Perceived Treatment Efficacy Primary · Baseline, immediately post-intervention, up to 30 minutes

Asks participants to rate the likelihood that engaging in treatment and adaptive behaviors will reduce the risk for developing psychosis, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater perceived efficacy. Measure is divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (3 items range 3-12), and d) help-seeking behav

Avoiding Unhealthy Behaviors

Group	Value	95% CI
Clinician Manual	2.6	± 2.9

Engaging in Healthy Behaviors

Group	Value	95% CI
Clinician Manual	1.6	± 2.6

Going to a specialized CHR Clinic

Group	Value	95% CI
Clinician Manual	0.5	± 1.7

Help Seeking Behaviors

Group	Value	95% CI
Clinician Manual	0.5	± 2.1

Change From Baseline in Intention to Use Treatment Primary · Baseline, Immediately post-intervention, up to 30 minutes

Asks participants to rate the likelihood of engaging in treatment and adaptive behaviors, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater intention. The measure was divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 items range 5-20), c) utilizing specialized CHR services (2 items range 2-8), and d) help-seeking behaviors (6 items range 6-24). Changes were measured pre-

Avoiding unhealthy behaviors

Group	Value	95% CI
Clinician Manual	0.9	± 1.1

Engaging in healthy behaviors

Group	Value	95% CI
Clinician Manual	1.0	± 2.4

Going to a specialized CHR clinic

Group	Value	95% CI
Clinician Manual	-0.3	± 1.0

Help Seeking behaviors

Group	Value	95% CI
Clinician Manual	-0.5	± 2.0

Change From Baseline in Self-Stigma About Genetic Risk for Psychosis Development Secondary · Baseline, Immediately post-intervention, up to 30 minutes

Assess participants self-stigma if they were told they had a genetic risk for psychosis. 7 items are included: I believe I would be fundamentally different from most people (range 1-4), I would be more likely to do something violent towards other people (range 1-4), I would be more likely to do something violent towards myself (range 1-4), I would be more likely to be unpredictable (range 1-4), I would feel ashamed of myself (range 1-4), I would feel embarrassed about myself (range 1-4), I would think of myself as less competent (range 1-4). each measured on a 4-point scale (1=strongly disagre

I believe I would be fundamentally different from most people

Group	Value	95% CI
Clinician Manual	-0.04	± 1.0

I would be more likely to do something violent towards other people

Group	Value	95% CI
Clinician Manual	0.0	± 0.5

I would be more likely to do something violent towards myself

Group	Value	95% CI
Clinician Manual	0.2	± 0.5

I would be more likely to be unpredictable

Group	Value	95% CI
Clinician Manual	-0.3	± 0.9

I would feel ashamed of myself

Group	Value	95% CI
Clinician Manual	-0.4	± 0.6

I would feel embarrassed about myself

Group	Value	95% CI
Clinician Manual	-0.3	± 0.6

I would think of myself as less competent

Group	Value	95% CI
Clinician Manual	-0.3	± 0.7

Change in Anticipated Discrimination From Others Due to Genetic Risk for Psychosis Development Secondary · Baseline, Immediately post-intervention, up to 30 minutes

Assess participants anticipated discrimination if they were told they had a genetic risk for psychosis. 18 items (each with a range of 1-4) are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater anticipated stigma. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose however, this is based off a published discrimination scale (Wahl, 1999). Change in scores from pre- to post-intervention for each item are reported.

Likelihood of being treated differently by mental health professionals

Group	Value	95% CI
Clinician Manual	-0.3	± 1.1

Likelihood of having trouble keeping or getting a job

Group	Value	95% CI
Clinician Manual	-0.4	± 0.8

Likelihood of being misunderstood by family

Group	Value	95% CI
Clinician Manual	0.0	± 0.9

Likelihood of being rejected by family

Group	Value	95% CI
Clinician Manual	0.0	± 0.7

Likelihood of having friends/acquaintances become more distant from you

Group	Value	95% CI
Clinician Manual	-0.04	± 0.7

Likelihood of being targeted by hurtful social media messages

Group	Value	95% CI
Clinician Manual	0.3	± 0.7

Likelihood of having your friends/acquaintances talk badly about you

Group	Value	95% CI
Clinician Manual	0.1	± 0.6

Likelihood of having your friends/acquaintances be afraid of you

Group	Value	95% CI
Clinician Manual	0.1	± 0.6

Anticipated Rejection From Others Due to Genetic Risk for Psychosis Development Secondary · Baseline, Immediately post-intervention, up to 30 minutes

Assess participants anticipated rejection if they were told they had a genetic risk for psychosis. 3 items (each with a range of 1-4) measured on a 4-point scale (1=very unconcerned, 2=somewhat unconcerned, 3=somewhat concerned, 4=very concerned), with higher scores indicating greater anticipated rejection. Because this is an exploratory R21 trial, the investigators are also testing and validating new measures for this specific group and purpose; however, these items are based off of a published rejection sensitivity scale (Link, Wells, Phelan, Yang, 2015). Change in scores from pre- to post-

Scenario 1: Dinner with friends

Group	Value	95% CI
Clinician Manual	-0.2	± 1.1

Scenario 2: Argument with a friend

Group	Value	95% CI
Clinician Manual	-0.4	± .8

Scenario 3: Dating someone new

Group	Value	95% CI
Clinician Manual	-0.1	± 1.1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.