Trial Outcomes & Findings for iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders (NCT NCT05899348)
NCT ID: NCT05899348
Last Updated: 2026-03-18
Results Overview
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.
COMPLETED
NA
69 participants
Change from Baseline to 16 week follow up assessment
2026-03-18
Participant Flow
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.
Participant milestones
| Measure |
iTEST
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.
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Overall Study
STARTED
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60
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Overall Study
COMPLETED
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52
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
Baseline characteristics by cohort
| Measure |
iTEST
n=60 Participants
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.
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Age, Continuous
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45.31 years
STANDARD_DEVIATION 11.15 • n=110 Participants
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Sex: Female, Male
Female
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31 Participants
n=110 Participants
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Sex: Female, Male
Male
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29 Participants
n=110 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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13 Participants
n=110 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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47 Participants
n=110 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=110 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=110 Participants
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Race (NIH/OMB)
Asian
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7 Participants
n=110 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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2 Participants
n=110 Participants
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Race (NIH/OMB)
Black or African American
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17 Participants
n=110 Participants
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Race (NIH/OMB)
White
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28 Participants
n=110 Participants
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Race (NIH/OMB)
More than one race
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6 Participants
n=110 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=110 Participants
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Region of Enrollment
United States · University of Texas at Dallas
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30 Participants
n=110 Participants
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Region of Enrollment
United States · University of California - San Diego
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30 Participants
n=110 Participants
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PANSS General
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27.53 units on a scale
STANDARD_DEVIATION 6.12 • n=110 Participants
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PRIMARY outcome
Timeframe: Change from Baseline to 16 week follow up assessmentIntrospective 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.
Outcome measures
| Measure |
iTEST
n=52 Participants
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.
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Trained Introspective Accuracy
Baseline
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3.70 score on a scale
Standard Error 0.91
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Trained Introspective Accuracy
16 Weeks
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-0.77 score on a scale
Standard Error 0.99
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PRIMARY outcome
Timeframe: Change from Baseline to 16 week follow up assessmentThe 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.
Outcome measures
| Measure |
iTEST
n=52 Participants
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.
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Untrained Introspective Accuracy on WCST
Baseline
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17.30 score on a scale
Standard Error 2.29
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Untrained Introspective Accuracy on WCST
16 week follow up
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14.66 score on a scale
Standard Error 2.41
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PRIMARY outcome
Timeframe: Cumulative adherence over 16 weeksCompletion of daily mobile prompts divided by the number possible across 16 weeks of training.
Outcome measures
| Measure |
iTEST
n=52 Participants
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.
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Adherence
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87.02 percentage of total prompts
Standard Deviation 14.1
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SECONDARY outcome
Timeframe: Change from Baseline Assessment to 16 week follow up AssessmentThe 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
Outcome measures
| Measure |
iTEST
n=52 Participants
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.
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Specific Level of Function Scale (Informant Version)
Baseline
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4.11 score on a scale
Standard Deviation 0.07
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Specific Level of Function Scale (Informant Version)
16 Week Follow up
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4.25 score on a scale
Standard Deviation 0.07
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Adverse Events
iTEST
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iTEST
n=52 participants at risk
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.
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Psychiatric disorders
Psychiatric hospitalization
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13.5%
7/52 • Number of events 7 • 16 weeks
Definitions do not differ from clinicaltrials.gov. Trained research personnel assessed for any serious medical or psychological conditions that may require immediate medical attention or psychiatric treatment .SAEs were reported to the DSMB, NIMH, and the HRPP within 24 hours.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place