iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders

NCT05899348 | Completed Results DMC

• 1 other identifier: 1R61MH129379-01A1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psychotic Disorders; Schizophrenia; Schizo Affective Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Cumulative adherence over 16 weeks

Secondary Outcomes (1)

• Specific Level of Function Scale (Informant Version)

  Change from Baseline Assessment to 16 week follow up Assessment

Study Arms (1)

iTEST

EXPERIMENTAL

Behavioral: iTEST

Interventions

iTEST BEHAVIORAL

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.

iTEST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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). The investigators will determine symptom and medication stability by best-estimate history with information from medical records;
• 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.

You may not qualify 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); 4) Unable to adequately see or manually manipulate a smartphone.

Sponsors & Collaborators

• University of California, San Diego: lead
• The University of Texas at Dallas: collaborator
• University of Miami: collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

Related Publications (1)

• Berretta SA, Abaya N, Parrish E, McBride LE, Moore RC, Ackerman R, Harvey PD, Pinkham AE, Depp CA. Protocol for evaluation of iTEST, a novel blended intervention to enhance introspective accuracy in psychotic disorders. NPP Digit Psychiatry Neurosci. 2025;3(1):5. doi: 10.1038/s44277-024-00024-7. Epub 2025 Feb 14.

  PMID: 39959603 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Open trial design does not rule out naturalistic change

Results Point of Contact

• Title: Colin Depp
• Organization: University of California, San Diego

cdepp@ucsd.edu

858 822 4251

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 12, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available by September 2025, which is within 6 months of the conclusion of the award. This is consistent with NIMH policy on the timing of data sharing and data will be shared in perpetuity.
• Access Criteria: Individuals seeking data access it through the National Data Archive wherein access controlled by the NIH

Locations

US (2)