Schizophrenia Clinical Trial
— iTESTOfficial title:
iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
United States | University of Texas at Dallas | Richardson | Texas |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | The University of Texas at Dallas, University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trained Introspective Accuracy | Introspective accuracy is measured daily basis from baseline to 16 weeks (average of introspective accuracy determined from self-reported estimated correct on the Variable Length List Learning Memory Test; Mobile Electronic Test of Emotion Recognition and actual correct). Each day, participants complete tasks in which the can obtain a number of correct responses in guessing the emotion depicted on a picture of a human face and remembering a list of words provided to them. Participants are then asked to guess how many items correctly identified and introspective accuracy is the absolute value of the difference between the guessed correct and actual correct. This number can range from zero to ten and lower scores reflect better introspective accuracy. There are two measures of introspective accuracy (one from a facial recognition task and the other from a word list task) and these are averaged within each day. | Change from Baseline to 16 week follow up assessment | |
Primary | Untrained Introspective Accuracy on WCST | The Metacognitive Wisconsin Card Sorting Test (WCST) is a secondary measure of introspective accuracy and involves the completion of the standard neuropsychological task (WCST) with simultaneous questions about the participants judgment of correctness. The primary unit of analysis is the difference between self-assessed correct and actual correct responses. | Change from Baseline to 16 week follow up assessment | |
Primary | Adherence | Completion of daily mobile prompts divided by the number possible | Change over 16 weeks | |
Secondary | Specific Level of Function Scale (Informant Version) | The Specific Level of Functioning (SLOF) is an informant rated scale of functioning in the community. The measure includes 43 items that address current work, self-care, social and related functional capacities. The summary variable is the higher order functional factor which combines work, independent living, and social functional capacity. The maximum score is 215 and the minimum score is 43, with higher scores reflective of better functioning | Change from Baseline Assessment to 16 week follow up Assessment |
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