NCT07098169 Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
| NCT ID | NCT07098169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Schizophrenia Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 201 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 201 participants in total. It began in 2025-09-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Amy Pinkham, PhD
PRINCIPAL INVESTIGATOR
The University of Texas at Dallas
Frequently Asked Questions
Who can join the NCT07098169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07098169 currently recruiting?
Yes, NCT07098169 is actively recruiting participants. Contact the research team at cdepp@ucsd.edu for enrollment information.
Where is the NCT07098169 trial being conducted?
This trial is being conducted at San Diego, United States, Miami, United States, Dallas, United States.
Who is sponsoring the NCT07098169 clinical trial?
NCT07098169 is sponsored by University of California, San Diego. The principal investigator is Amy Pinkham, PhD at The University of Texas at Dallas. The trial plans to enroll 201 participants.
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