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Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks."
  • "Therefore, in this trial phase R33, the intervention will last for 12 weeks with a 3-month follow-up."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests iTEST for adults with schizophrenia or schizoaffective disorder, conditions that can affect thoughts and a sense of what is real. iTEST uses daily brain training on a mobile device and coaching to help people better judge their own abilities. The 12-week study compares iTEST with training and coaching that do not focus on this skill, and looks at how well people manage daily life.

The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Choose to join and pass a short test showing you understand what joining means.
  • Have schizophrenia or schizoaffective disorder, confirmed by an interview and any available medical records.
  • Read at a 6th-grade level or higher on a reading test.
  • Have stable symptoms and treatment, with no hospital stays or changes in medication type in the past 2 months.
  • Have a mental health worker, family member, or friend who has contact with you at least monthly and can share information about you.
  • Have some trouble with daily life tasks. People who both work full time and are financially responsible for their household cannot join.

Who can't join

  • Have more than moderate trouble organizing thoughts, based on a symptom rating scale.
  • Have had alcohol or drug dependence in the past 3 months, based on an interview.
  • Need care that prevents taking part in therapy without a hospital stay, such as being hospitalized or having a severe medical illness.
  • Be unable to see a smartphone screen well enough or use the phone with your hands.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (3)

CA

FL

TX