NCT07098169Recruiting
Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- Sept 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- University of California, San Diego
- Diseases
- Schizophrenia
- NCT number
- NCT07098169
What you commit to
- Study type: Interventional
- Planned participants: 201
- From Sept 2025 to the primary completion date, Feb 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5)
- Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
Other
- DSM-5 alcohol or substance dependence in past 3 months based on interview
Who the study is looking for
- Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
- Age 18 to 65;
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
- ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
- 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;
- 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
- Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas at Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| UC San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.