Protocol for evaluation of iTEST, a novel blended intervention to enhance introspective accuracy in psychotic disorders.
Sarah A Berretta, Nicole Abaya, Emma Parrish...
https://pubmed.ncbi.nlm.nih.gov/39959603/Actively Recruiting
Led by University of California, San Diego · Updated on 2026-01-23
201
Participants Needed
3
Research Sites
8 weeks
Total Duration
Researchers are evaluating iTEST, a new psychosocial intervention for people with psychotic disorders such as schizophrenia and schizoaffective disorder. The study aims to improve introspective accuracy, which is the ability to accurately assess ones own abilities, a factor linked to functional disability. This NIH-supported trial is a phase two program to replicate earlier findings in a larger randomized control trial involving 201 participants across three metropolitan areas San Diego, Dallas, and Miami. Participants will be randomly assigned to either the iTEST intervention or an active control condition. Both groups receive 12 weeks of coachinginitially weekly 60-minute sessions for six weeks, followed by three bi-weekly 30-minute booster callsdelivered by telehealth or in person. Both groups perform daily cognitive tasks on a mobile device, but only iTEST focuses on improving self-assessment accuracy through feedback and coaching related to introspective accuracy, while the control group receives general cognitive feedback and psychoeducation on sleep, physical activity, and social connection. During the study, participants will complete assessments at baseline, 6, 12, and 24 weeks. Researchers will evaluate community functioning as the primary outcome using the Informant-Rated Specific Level of Function SLOF Scale. Participants will be monitored for adherence to the mobile cognitive tasks and coaching sessions. The study includes a 3-month follow-up after the 12-week intervention to measure lasting effects on functional outcomes and introspective accuracy.
CONDITIONS
Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
C
Colin A Depp, Ph.D.
N
Nikki Abaya, MA
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University of California, San Diego
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | iTEST: Mobile Training + Metacognition Coaching | Active Mobile-Based Control |
|---|---|---|
| What it is | Computerized cognitive training delivered via mobile device, combined with therapist or coach-led metacognitive training designed to improve introspective accuracy in daily functioning. | Mobile cognitive tests with feedback about performance, combined with coaching and structured psychoeducation on general cognitive health topics. |
| Role in the trial | Tested as the primary experimental intervention targeting metacognitive skills and self-assessment accuracy in schizophrenia and schizoaffective disorder. | Serves as the comparator, controlling for coaching and mobile cognitive assessment without addressing introspective accuracy. |
| Primary use | Improving the accuracy of self-assessment and metacognitive awareness to enhance functional outcomes in individuals with schizophrenia spectrum disorders. | Providing structured psychoeducation and cognitive assessment to support general cognitive health and enhance engagement without explicitly training introspective accuracy. |
| How it is given or performed | Delivered through daily mobile-device cognitive tests and exercises, with ongoing therapist/coach sessions to guide metacognitive skill application. | Mobile cognitive tests with performance feedback, plus structured sessions with a coach providing psychoeducation, without metacognitive or accuracy training. |
| Evidence/status | iTEST is investigational and being evaluated in this randomized clinical trial; effectiveness for improving self-assessment accuracy in psychotic disorders is not yet established. | The active control condition acts as a comparison group in this study and is not intended to improve introspective accuracy; its effect on everyday function is not expected to equal iTEST. |
| Important limitations | Effectiveness for improving real-world outcomes is not yet known. Participants must be familiar with using mobile devices and able to commit to regular engagement with cognitive tasks and coaching. | No active training of metacognitive skills or introspective accuracy; effects on main clinical outcomes are expected to be limited compared to the investigational arm. Requires mobile device use and participant engagement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 12 weeks
Participants receive a 12-week blended behavioral intervention involving daily mobile cognitive tasks and coaching sessions aimed at improving introspective accuracy or attention control depending on randomization.
Weekly 60-minute coaching sessions for 6 weeks followed by 3 bi-weekly 30-minute booster calls; daily mobile cognitive tasks throughout the 12 weeks
Duration - 3 months
Participants are followed for 3 months after treatment to assess lasting effects on function.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sarah A Berretta, Nicole Abaya, Emma Parrish...
https://pubmed.ncbi.nlm.nih.gov/39959603/University of California, San Diego
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor