Schizophrenia DisordersiTEST R33NCT07098169
Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
A study testing iTEST in people with Schizophrenia Disorders and Schizoaffective Disorder, run by University of California, San Diego at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorders, Schizoaffective Disorder, Psychotic Disorder
- What is being tested?
- iTEST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Texas at Dallas
Dallas, Texas, 75080
Amy Pinkham, PhD, 972-883-4462, amy.pinkham@utdallas.edu
- Recruiting
University of Miami
Miami, Florida, 33146
Philip Harvey, PhD, 305-243-6400, pharvey@miami.edu
- Recruiting
UC San Diego
San Diego, California, 92093
Colin Depp, PhD, 858-822-4251, cdepp@ucsd.edu
Nikki Abaya, MA, (858) 869 0031, niabaya@health.ucsd.edu
About this study
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.
Read the detailed description
This NIH-supported clinical trial is the second phase of a two-phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal of this second R33 phase is to evaluate the replicability of R61 findings in a larger randomized control trial with iTEST, a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, vs. a control condition that is time-equivalent but does not train in introspective accuracy. 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. 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 open trial phase, people with psychotic disorders with at least minimal functional impairment were recruited and found that the intervention led to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). It was determined that the dose of intervention needed to achieve clinically significant improvement in IA targets was achieved at 12 weeks. Therefore, in this trial phase R33, the intervention will last for 12 weeks with a 3-month follow-up. A total of 201 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial
- Being tested
- iTEST, Active Control
- Keywords
- Digital health, Cognitive training, Schizophrenia, Psychosis, Functional rehabilitation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTESTBehavioural
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
Active ControlBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The University of Texas at Dallas, University of Miami
- Responsible party
- Principal investigator, Colin Depp, University of California, San Diego
- Investigators
- Amy Pinkham, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098169
- Sponsor's protocol ID
- 4R33MH129379
- Acronym
- iTEST R33
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from measures administered
Publications
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.
PubMed 39959603
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
- ClinicalTrials.gov ID
- NCT07098169
- Acronym / sponsor ID
- iTEST R33 / 4R33MH129379
- Keywords
- Digital health, Cognitive training, Schizophrenia, Psychosis, Functional rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The University of Texas at Dallas, University of Miami
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This NIH-supported clinical trial is the second phase of a two-phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal of this second R33 phase is to evaluate the replicability of R61 findings in a larger randomized control trial with iTEST, a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, vs. a control condition that is time-equivalent but does not train in introspective accuracy. 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. 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 open trial phase, people with psychotic disorders with at least minimal functional impairment were recruited and found that the intervention led to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). It was determined that the dose of intervention needed to achieve clinically significant improvement in IA targets was achieved at 12 weeks. Therefore, in this trial phase R33, the intervention will last for 12 weeks with a 3-month follow-up. A total of 201 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm randomized
| Arm | Type | Receives |
|---|---|---|
| iTEST | Experimental | Behavioral: iTESTiTEST 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. |
| Active Control | Active comparator | Behavioral: Active ControlThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTESTiTEST 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 | Behavioural | iTEST |
| Active ControlBehavioral: 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 | Behavioural | Active Control |
Primary outcome
Informant-Rated Specific Level of Function (SLOF) Scale
Time frame: Change from baseline to 3 month follow up
Measure of participant's community functioning rated by an informant. Scale scores range from 43 to 215 with higher scores reflecting better functioning.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 39959603Berretta 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.
- Individual participant dataSharing planned: Yes. De-identified data from measures administered
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Pinkham, PhD principal investigator
The University of Texas at Dallas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTEST in people with Schizophrenia Disorders and Schizoaffective Disorder, run by University of California, San Diego at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin A Depp, Ph.D. (858-822-4251, cdepp@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informant-Rated Specific Level of Function (SLOF) Scale (time frame: Change from baseline to 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07098169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.