iTEST: a blended mobile program to improve introspective accuracy (accurate self-judgment of abilities)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multisite trial compares iTEST, a blended intervention combining graduated mobile drill-and-practice to train introspective accuracy with personalized coaching, to an active control that provides time-equivalent coaching and cognitive training without an IA emphasis. Participants are randomized to one of the two arms and complete the 12-week intervention with assessments at baseline, 6, 12, and 24 weeks. The primary outcome is community functioning, and secondary outcomes include task-based measures of introspective accuracy and transfer to everyday behaviors. The trial is the R33 phase following an initial R61 open trial and is conducted at sites in San Diego, Dallas, and Miami.

Why it matters

Who can join: the full rules

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 it's running

• UC San Diego
  San Diego, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• University of Texas at Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Amy Pinkham, PhD — The University of Texas at Dallas
• Study coordinator: Colin A Depp, Ph.D.
• Email: cdepp@ucsd.edu
• Phone: 858-822-4251

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cognitive Strategies in Early Psychosis 2 – how brain games and pills test decision making

  This study tests whether a single dose of modafinil or d-serine, compared with placebo, changes decision making in people aged 18–35 who have recently begun experiencing psychosis.

  Recruiting Phase 3 University of Minnesota · Minneapolis, Minnesota · NCT07263022

• Connectivity-guided theta-burst stimulation targeting the hippocampus in schizophrenia

  We will try targeted theta-burst TMS guided by brain connectivity to change hippocampus activity in adults with schizophrenia or related psychotic disorders, measuring brain signals with EEG and, for some participants, intracranial electrodes.

  Recruiting Stanford University · Stanford, California · NCT07010614

• Using 40 Hz visual stimulation to help with negative symptoms in schizophrenia

  This study is testing if 40 Hz visual stimulation can help people with schizophrenia or schizoaffective disorder feel better by reducing negative symptoms.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT06907420

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Can seven tasks help distinguish schizophrenia and schizoaffective disorder from healthy people

  The study tests seven cognitive tasks to see if they can tell apart people with schizophrenia or schizoaffective disorder from healthy adults and predict symptoms like hallucinations and delusions.

  Recruiting at 5 sites Washington University School of Medicine · Irvine, California and 4 other locations · NCT07853807

• State Representation in Early Psychosis 2

  This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.

  Recruiting at 2 sites University of Minnesota · Minneapolis, Minnesota and 1 other locations · NCT07834203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.