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

NCT ID: NCT05899348

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-08-01

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

Detailed Description

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

Conditions

Schizophrenia; Schizo Affective Disorder; Psychotic Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iTEST

Group Type: EXPERIMENTAL

iTEST

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)

2. Age 18 to 65;

3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;

4. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);

5. 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;

6. 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

7. Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.

Exclusion Criteria

1. Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item >5)

2. DSM-5 alcohol or substance dependence in past 3 months based on interview

3. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Colin Depp

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, San Diego

La Jolla, California, United States

University of Texas at Dallas

Richardson, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39959603 (View on PubMed)

Other Identifiers

1R61MH129379-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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