RecruitingNot ApplicableNCT07098169

Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy

Sponsor

University of California, San Diego

Enrollment

201 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Disorders Schizoaffective Disorder Psychotic Disorder

Summary

The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool called iTEST that is designed to help people with schizophrenia or schizoaffective disorder better understand and track their own thinking, mood, and daily functioning. Researchers want to see if this blended in-person and app-based program improves insight and real-world outcomes. **You may be eligible if...** - You are aged 18–65 - You have a diagnosis of schizophrenia or schizoaffective disorder - Your symptoms and medications have been stable for at least 2 months - You can read at about a 6th-grade level - You have a clinician, case manager, family member, or friend who sees you at least once a month - You are not fully employed and financially independent (study targets those with some functional impairment) **You may NOT be eligible if...** - You have severe disorganized thinking - You have had alcohol or substance dependence in the past 3 months - You are currently hospitalized or have a severe medical illness - You cannot see well enough or use a smartphone physically Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALiTEST

iTEST is a computerized training intervention delivered on a mobile device that is coupled with individual contacts with a therapist/coach. The mobile components train in improving participant's ability to form accurate judgments about their performance and their rate of functional activities. The intervention involves coaching coupled with automated training that is delivered on a mobile device. The automated training involves daily cognitive tests in which the goal for treatment is to improve judgments of accuracy of self-assessment, and coaching is aimed at applying improving metacognitive awareness to every day activities. i

BEHAVIORALActive Control

Behavioral: Mobile cognitive tests will be administered to control subjects. Participants will receive feedback regarding their performance but not on the accuracy of their self-ratings. Coaching will also be coupled with mobile cognitive tests and will include goal-setting without specific mention of Introspective Accuracy (IA). in place of content related to IA, participants will receive psychoeducation about the benefits of sleep, physical activity, and social connection to overall cognitive health