An interventional study of iTEST in Schizophrenia, Schizo Affective Disorder and Psychotic Disorders, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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
This NIH-supported clinical trial is the first phase of a two phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal is to evaluate a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, with the ultimate goal of improving functional outcome. Introspective accuracy is the degree to which one's self-assessment of performance or abilities corresponds with objective data. Recent research indicates that poor IA is an independent predictor of functional disability. Yet, there are currently no treatments that directly target IA. Basic experimental research and other lines of evidence suggest IA is malleable, and that improvement in task-based IA transfers to untrained tasks. This project's premise is that task-based IA training could be delivered in a remote mobile health format and coupled with coaching in applying improved IA to real-world functional behaviors, creating a novel avenue for functional rehabilitation in psychotic disorders. The investigators have developed and completed usability testing of iTEST, a novel blended IA targeted mobile intervention. iTEST integrates graduated drill-and-practice training in IA delivered on a mobile device with personalized coaching in applying IA to everyday compensatory behaviors. In the R61 phase trial here, the investigators will recruit people with psychotic disorders with at least minimal functional impairment. The investigators will conduct an open trial of iTEST, evaluating whether the intervention leads to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). The investigators will also determine the dose of intervention needed to achieve clinically significant improvement in IA targets, by evaluating change at 8, 12, or 16 weeks. The go/no go criteria for this trial are 75% adherence and clinically significant increases in introspective accuracy. A total of 60 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 69 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Behavioral: iTEST
iTEST is a computerized training intervention delivered on a mobile device that is coupled with individual contacts with a therapist/coach. The mobile components train in improving participant's ability to form accurate judgments about their performance and their rate of functional activities. The intervention involves coaching coupled with automated training that is delivered on a mobile device. The automated training involves daily cognitive tests in which the goal for treatment is to improve judgments of accuracy of self-assessment, and coaching is aimed at applying improving metacognitive awareness to every day activities.
Trained Introspective Accuracy
Introspective accuracy is measured daily basis from baseline to 16 weeks (average of introspective accuracy determined from self-reported estimated correct on the Variable Length List Learning Memory Test; Mobile Electronic Test of Emotion Recognition and actual correct). Each day, participants complete tasks in which the can obtain a number of correct responses in guessing the emotion depicted on a picture of a human face and remembering a list of words provided to them. Participants are then asked to guess how many items correctly identified and introspective accuracy is the absolute value of the difference between the guessed correct and actual correct. This number can range from zero to ten and lower scores reflect better introspective accuracy. There are two measures of introspective accuracy (one from a facial recognition task and the other from a word list task) and these are averaged within each day.
Time frame: Change from Baseline to 16 week follow up assessment
Untrained Introspective Accuracy on WCST
The Metacognitive Wisconsin Card Sorting Test (WCST) is a secondary measure of introspective accuracy and involves the completion of the standard neuropsychological task (WCST) with simultaneous questions about the participants judgment of correctness. The primary unit of analysis is the difference between self-assessed correct and actual correct responses. The WCST is a cognitive task that is administered by a trained rater. The scale would be the subtraction from a maximum of 64 correct and a minimum of 0 correct from the total guessed accurate (maximum of 64 or minimum of 0). Therefore the range of raw introspective accuracy scores would be from -64 to 64 and this score is then converted to an absolute value . Better introspective accuracy would be reflected by a score closer to 0.
Time frame: Change from Baseline to 16 week follow up assessment
Adherence
Completion of daily mobile prompts divided by the number possible across 16 weeks of training.
Time frame: Cumulative adherence over 16 weeks
Specific Level of Function Scale (Informant Version)
The Specific Level of Functioning (SLOF) is an informant rated scale of functioning in the community. The measure includes 43 items that address current work, self-care, social and related functional capacities. The summary variable is the higher order functional factor which combines work, independent living, and social functional capacity. Each item is rated on a 1 to 5 scale where the maximum score is 5 and the minimum score is 1. The scale score is the average score rating (range of 1 to 5) with higher scores reflective of better functioning
Time frame: Change from Baseline Assessment to 16 week follow up Assessment
Recruitment settings included associated medical centers, public mental health clinics, local community clinics, and non-profit organizations through flyers, clinician referrals, word-of-mouth outreach, and online advertisements.
| Milestone | iTEST |
|---|---|
| Started | 60 |
| Completed | 52 |
| Not completed | 8 |
Introspective accuracy is measured daily basis from baseline to 16 weeks (average of introspective accuracy determined from self-reported estimated correct on the Variable Length List Learning Memory Test; Mobile Electronic Test of Emotion Recognition and actual correct). Each day, participants complete tasks in which the can obtain a number of correct responses in guessing the emotion depicted on a picture of a human face and remembering a list of words provided to them. Participants are then asked to guess how many items correctly identified and introspective accuracy is the absolute value of the difference between the guessed correct and actual correct. This number can range from zero to ten and lower scores reflect better introspective accuracy. There are two measures of introspective accuracy (one from a facial recognition task and the other from a word list task) and these are averaged within each day.
| score on a scale | iTEST |
|---|---|
| Baseline | 3.70 ± 0.91 |
| 16 Weeks | -0.77 ± 0.99 |
The Metacognitive Wisconsin Card Sorting Test (WCST) is a secondary measure of introspective accuracy and involves the completion of the standard neuropsychological task (WCST) with simultaneous questions about the participants judgment of correctness. The primary unit of analysis is the difference between self-assessed correct and actual correct responses. The WCST is a cognitive task that is administered by a trained rater. The scale would be the subtraction from a maximum of 64 correct and a minimum of 0 correct from the total guessed accurate (maximum of 64 or minimum of 0). Therefore the range of raw introspective accuracy scores would be from -64 to 64 and this score is then converted to an absolute value . Better introspective accuracy would be reflected by a score closer to 0.
| score on a scale | iTEST |
|---|---|
| Baseline | 17.30 ± 2.29 |
| 16 week follow up | 14.66 ± 2.41 |
Completion of daily mobile prompts divided by the number possible across 16 weeks of training.
| percentage of total prompts | iTEST |
|---|---|
| Adherence | 87.02 ± 14.1 |
The Specific Level of Functioning (SLOF) is an informant rated scale of functioning in the community. The measure includes 43 items that address current work, self-care, social and related functional capacities. The summary variable is the higher order functional factor which combines work, independent living, and social functional capacity. Each item is rated on a 1 to 5 scale where the maximum score is 5 and the minimum score is 1. The scale score is the average score rating (range of 1 to 5) with higher scores reflective of better functioning
| score on a scale | iTEST |
|---|---|
| Baseline | 4.11 ± 0.07 |
| 16 Week Follow up | 4.25 ± 0.07 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iTEST | 0/52 (0%) | 0/52 (0%) | 7/52 (13.5%) |
| Event | iTEST |
|---|---|
| Psychiatric hospitalizationPsychiatric disorders | 7/52 |
| Age, Continuous(years) | iTEST |
|---|---|
| Mean | 45.31 ± 11.15 |
| Sex: Female, Male(Participants) | iTEST |
|---|---|
| Female | 31 |
| Male | 29 |
| Ethnicity (NIH/OMB)(Participants) | iTEST |
|---|---|
| Hispanic or Latino | 13 |
| Not Hispanic or Latino | 47 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | iTEST |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 17 |
| White | 28 |
| More than one race | 6 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | iTEST |
|---|---|
| United States — University of Texas at Dallas | 30 |
| United States — University of California - San Diego | 30 |
| PANSS General(units on a scale) | iTEST |
|---|---|
| Mean | 27.53 ± 6.12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A condition of funding is that IPD is made available to other researchers through the National Data Archive of the NIMH. The investigative team will deposit and share data in the NIMH National Data Archive and the investigative team has budgeted staff time of 100 hours per year to accomplish the preparation, curation, and uploading of semiannual de-identified data as the study progresses (linked with Global Unique Identifiers) to the online system in collaboration with NIH staff. • The investigative team will develop documents and tools to support this dissemination, in particular for the sharing ecological momentary assessment data which presents data management challenges in its volume and complexity, including within-person aggregation scripts that can be used to analyze the data at the day and week level. IPD that will be shared include all de-identified study data
Supporting information: Study protocol, Sap
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Diego