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

This NIH-supported clinical trial is the second phase of a two-phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal of this second R33 phase is to evaluate the replicability of R61 findings in a larger randomized control trial with iTEST, a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, vs. a control condition that is time-equivalent but does not train in introspective accuracy. Introspective accuracy is the degree to which one's self-assessment of performance or abilities corresponds with objective data. Recent research indicates that poor IA is an independent predictor of functional disability. Yet, there are currently no treatments that directly target IA. Basic experimental research and other lines of evidence suggest IA is malleable, and that improvement in task-based IA transfers to untrained tasks. The investigators have developed and completed usability testing of iTEST, a novel blended IA targeted mobile intervention. iTEST integrates graduated drill-and-practice training in IA delivered on a mobile device with personalized coaching in applying IA to everyday compensatory behaviors. In the R61 open trial phase, people with psychotic disorders with at least minimal functional impairment were recruited and found that the intervention led to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). It was determined that the dose of intervention needed to achieve clinically significant improvement in IA targets was achieved at 12 weeks. Therefore, in this trial phase R33, the intervention will last for 12 weeks with a 3-month follow-up. A total of 201 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial

Inclusion criteria

• 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.

Exclusion criteria

• Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item >5)
• DSM-5 alcohol or substance dependence in past 3 months based on interview
• Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.