iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders (NCT05899348) | Clinical Trial Compass
CompletedNot Applicable
iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
United States69 participantsStarted 2023-10-01
Plain-language summary
People with psychotic disorders experience a high level of functional disability, and a major contributor to this disability is introspective accuracy, which is defined as inaccurate judgements of one's abilities and performance on tasks. Yet, no intervention has directly targeted introspective accuracy for psychotic illnesses. This trial will evaluate a new intervention, called iTEST, that uses mobile devices to train people with psychotic disorders to improve introspective accuracy and, ultimately, functional outcomes
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Trained Introspective Accuracy
Timeframe: Change from Baseline to 16 week follow up assessment
2
Untrained Introspective Accuracy on WCST
Timeframe: Change from Baseline to 16 week follow up assessment
. 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.