Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy

NCT07098169 | Recruiting DMC

• 1 other identifier: 4R33MH129379
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.

Conditions

Schizophrenia Disorders; Schizoaffective Disorder; Psychotic Disorder

Keywords

Digital health; Cognitive training; Schizophrenia; Psychosis; Functional rehabilitation

Outcome Measures

Primary Outcomes (1)

• Informant-Rated Specific Level of Function (SLOF) Scale

  Measure of participant's community functioning rated by an informant. Scale scores range from 43 to 215 with higher scores reflecting better functioning.

  Change from baseline to 3 month follow up

Study Arms (2)

iTEST

EXPERIMENTAL

iTEST includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. ITEST also includes daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants guess the number correct after each task and are provided feedback on the accuracy of their guesses. These tasks occur once per day days per week and continue occur over 12 weeks.

Behavioral: iTEST

Active Control

ACTIVE COMPARATOR

The control condition includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. Participants also complete daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants are provided feedback their performance. These tasks occur once per day days per week and continue occur over 12 weeks.

Behavioral: Active Control

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. i

iTEST

Active Control BEHAVIORAL

Behavioral: Mobile cognitive tests will be administered to control subjects. Participants will receive feedback regarding their performance but not on the accuracy of their self-ratings. Coaching will also be coupled with mobile cognitive tests and will include goal-setting without specific mention of Introspective Accuracy (IA). in place of content related to IA, participants will receive psychoeducation about the benefits of sleep, physical activity, and social connection to overall cognitive health

Active Control

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
• National Institute of Mental Health (NIMH): collaborator
• The University of Texas at Dallas: collaborator
• University of Miami: collaborator

Study Sites (3)

UC San Diego

San Diego, California, 92093, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

RECRUITING

University of Texas at Dallas

Dallas, Texas, 75080, United States

RECRUITING

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 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Amy Pinkham, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin A Depp, Ph.D.

CONTACT

858-822-4251; cdepp@ucsd.edu

Nikki Abaya, MA

CONTACT

(858) 869 0031; niabaya@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel arm randomized

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data availability is at the end of the study (2028) and there is no end date
• Access Criteria: Qualified researchers who are eligible to access the NDA system

Locations

US (3)