iTEST: a blended mobile program to improve introspective accuracy (accurate self-judgment of abilities)
Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
This trial tests whether iTEST — daily mobile cognitive training plus coaching that focuses on accurate self-judgment — helps adults with schizophrenia-spectrum or other psychotic disorders improve community functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Trial ID | NCT07098169 on ClinicalTrials.gov |
What this trial studies
This randomized, multisite trial compares iTEST, a blended intervention combining graduated mobile drill-and-practice to train introspective accuracy with personalized coaching, to an active control that provides time-equivalent coaching and cognitive training without an IA emphasis. Participants are randomized to one of the two arms and complete the 12-week intervention with assessments at baseline, 6, 12, and 24 weeks. The primary outcome is community functioning, and secondary outcomes include task-based measures of introspective accuracy and transfer to everyday behaviors. The trial is the R33 phase following an initial R61 open trial and is conducted at sites in San Diego, Dallas, and Miami.
Who should consider this trial
Good fit: Adults aged 18–65 with a DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder who can consent, have at least a sixth-grade reading level, are clinically stable, and show some functional impairment match the study criteria.
Not a fit: People who are fully employed and financially independent, who have unstable symptoms or recent medication/hospital changes, who lack basic reading or smartphone skills, or who cannot provide informed consent are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, iTEST could help people with psychotic disorders more accurately judge their abilities and translate that awareness into better everyday community functioning.
How similar studies have performed: An earlier R61 open-phase trial reported clinically significant improvements in task-based introspective accuracy, but larger randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC) 2. Age 18 to 65; 3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review; 4. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device); 5. Stable co-treatments (no hospitalizations or medication class changes in 2 months before enrollment). The investigators will determine symptom and medication stability by best-estimate history with information from medical records; 6. Availability of a clinician (staff member, case manager, other mental health clinician) or close associate (family member, friend) with at least monthly contact who can be their informant 7. Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household. Exclusion Criteria: 1. Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5) 2. DSM-5 alcohol or substance dependence in past 3 months based on interview 3. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
Where this trial is running
San Diego, California and 2 other locations
- UC San Diego — San Diego, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- University of Texas at Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Amy Pinkham, PhD — The University of Texas at Dallas
- Study coordinator: Colin A Depp, Ph.D.
- Email: cdepp@ucsd.edu
- Phone: 858-822-4251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.