Improving self-awareness in people with psychotic disorders
iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
This study is testing a new program using mobile devices to help people with psychotic disorders, like schizophrenia, better understand their own abilities and improve their daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT05899348 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel intervention called iTEST, which aims to enhance introspective accuracy in individuals with psychotic disorders such as schizophrenia and schizoaffective disorder. The intervention utilizes mobile devices to provide training that helps participants better assess their abilities and performance. By improving introspective accuracy, the study seeks to enhance overall functional outcomes for these individuals. The trial is part of a larger program supported by the NIH, focusing on psychosocial therapeutic interventions for mental disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder who have stable treatment and a minimum level of functional impairment.
Not a fit: Patients who are fully employed and financially independent may not benefit from this study as they do not meet the functional impairment criteria.
Why it matters
Potential benefit: If successful, this intervention could significantly improve daily functioning and quality of life for patients with psychotic disorders.
How similar studies have performed: While this approach to directly target introspective accuracy in psychotic disorders is novel, previous studies have indicated that similar interventions can lead to improvements in related areas.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California and 1 other locations
- University of California, San Diego — La Jolla, California, United States (Recruiting)
- University of Texas at Dallas — Richardson, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Colin Depp, Ph.D.
- Email: cdepp@ucsd.edu
- Phone: 858 822 4251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.