Clinical trial for Schizophrenia Disorders
Official title Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
ClinicalTrials.gov ID: NCT07098169
What this study is testing
- What it's testing
- This study is testing whether a program called iTEST helps people better judge their own abilities. It also looks at how well people function in their daily lives.
- Who it's for
- You may be able to join if you have a psychotic disorder like schizophrenia.
- What's involved
- You would use a phone app for daily training. You would also meet with a coach to talk about your goals.
- Time commitment
- The program lasts 12 weeks, with check-ins at the start, 6 weeks, 12 weeks, and 24 weeks.
- Time commitment: about 12 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
- Age 18 to 65;
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
- ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
- Stable co-treatments (no hospitalizations or medication class changes in 2 months before enrollment).
You likely can't join if
- Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5)
- DSM-5 alcohol or substance dependence in past 3 months based on interview
- Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness)
See the full eligibility criteria
- Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
- Age 18 to 65;
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
- ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
- Stable co-treatments (no hospitalizations or medication class changes in 2 months before enrollment).
- 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
- Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.
- Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5)
- DSM-5 alcohol or substance dependence in past 3 months based on interview
- Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Miami, Florida, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Miami, Florida, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.