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
Conditions:
🦠 Schizophrenia 🦠 Schizo Affective Disorder 🦠 Psychotic Disorders
🗓️ Study Start (Actual) 1 October 2023
🗓️ Primary Completion (Estimated) 1 February 2025
✅ Study Completion (Estimated) 1 February 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 La Jolla, California, United States
📍 Richardson, Texas, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2023
  • First Submitted that Met QC Criteria 2 June 2023
  • First Posted 12 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 April 2024
  • Last Update Posted 10 April 2024
  • Last Verified April 2024