iTEST for Psychosis

(iTEST R33 Trial)

Recruiting at 2 trial locations

Overseen By Nikki Abaya, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance dependence, Severe medical illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

201 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new psychosocial treatment called iTEST, designed to help individuals with psychotic disorders, such as schizophrenia, improve their understanding of their mental abilities. The iTEST program combines daily mental exercises on a mobile app with coaching that focuses on personal recovery goals. Participants will be divided into two groups: one will use iTEST, and the other will receive similar coaching without the self-assessment focus. The researchers aim to determine if iTEST improves daily living skills. Suitable candidates include those diagnosed with schizophrenia or schizoaffective disorder, who have not changed medications or been hospitalized in the past two months, and are not currently working full-time. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance personal recovery strategies for psychotic disorders.

Do I have to stop taking my current medications for the iTEST for Psychosis trial?

The trial does not specify that you need to stop taking your current medications. However, your treatments must be stable, meaning no hospitalizations or changes in medication class for 2 months before joining the trial.

What prior data suggests that the iTEST intervention is safe for people with psychotic disorders?

Research has shown that the iTEST treatment is generally easy for patients to handle. One study found that the cognitive tasks used in iTEST provide consistent results over time. These tasks are also well-tolerated by individuals with schizophrenia, a type of psychotic disorder, meaning participants usually don't experience negative side effects from them.

As a psychosocial treatment rather than a medication, iTEST is less likely to cause severe side effects that drugs might. The treatment includes coaching and daily mental exercises, designed to be safe for participants, making it a low-risk option for many considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iTEST for psychosis because it combines personalized coaching with cognitive tasks to enhance memory and emotional recognition. Unlike traditional treatments that mainly focus on medication and therapy sessions, iTEST provides real-time feedback on cognitive performance, encouraging active participation and self-awareness. This innovative approach leverages both telehealth and in-person options, offering flexibility and accessibility for participants, which could lead to improved outcomes and engagement.

What evidence suggests that this trial's treatments could be effective for psychotic disorders?

Research shows that specific programs can help people improve their ability to accurately judge their own abilities. In this trial, participants will join one of two groups: the iTEST program or an active control group. iTEST is the first program designed to help individuals with psychotic disorders enhance this skill. Studies suggest that improving this ability can lead to better daily life and community involvement. iTEST combines daily brain exercises and personal coaching to achieve this goal. While direct evidence on iTEST's effectiveness is still being gathered, it is based on methods that have shown promise in similar contexts. ^{1 2 6 7 8}

Who Is on the Research Team?

Amy Pinkham, PhD

Principal Investigator

University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for individuals with psychotic disorders such as schizophrenia or schizoaffective disorder, who are located in San Diego, Dallas, or Miami. Participants should be able to engage in a 12-week program involving cognitive training and coaching.

Inclusion Criteria

I have been diagnosed with schizophrenia or schizoaffective disorder.

I understand and agree to participate in the study willingly.

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

Exclusion Criteria

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

I need constant medical care that prevents me from receiving outpatient treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the iTEST intervention or a control condition over 12 weeks, including weekly coaching sessions and daily cognitive tasks

12 weeks

6 weekly coaching sessions (in-person or telehealth), 3 bi-weekly booster calls

Follow-up

Participants are monitored for changes in community functioning and introspective accuracy after treatment

12 weeks

Assessments at 6 weeks, 12 weeks, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• iTEST

Trial Overview The study tests iTEST, a psychosocial intervention that combines mobile cognitive training with goal-oriented coaching to improve introspective accuracy. It's compared against an active control group receiving standard coaching and cognitive training without the introspective focus.

How Is the Trial Designed?

Group I: iTEST Experimental Treatment 1 Intervention

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.

Group II: Active Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11825358/

Protocol for evaluation of iTEST, a novel blended ... iTEST is the first intervention to specifically target IA in populations with psychotic disorders. Prior research suggests that IA is malleable ...

2. withpower.com withpower.com/trial/phase-disease-9-2023-2ab50

iTEST for Psychotic Disorders (iTEST Trial) In a study of 3074 patients diagnosed with acute and transient psychotic disorders (ATPD), 46.25% developed persistent psychotic disorders within 8 years, ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00116-0/fulltext

Comparing interventions for early psychosis: a systematic ... ... interventions for weight outcomes associated with psychotic ... ∙ Prina, A.M. ∙ et al. Cost-effectiveness of early intervention in psychosis: ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0920996424000689

The effectiveness of public health interventions, initiatives ... CHR-P is an early and potentially prodromal phase of psychosis characterised by a drop in functioning and psychotic symptoms of lesser severity and duration ...

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ps.202100506

A Scoping Review of Measures Used in Early Intervention ... This comprehensive review evaluated measures used in EIS for psychosis to monitor multiple aspects of patient and family presentations and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2215001322000130

Measuring functional outcomes in schizophrenia in an ... The measures exhibit good test-retest reliability and are well tolerated among patients with schizophrenia (Becattini-Oliveira et al., 2018). The task requires ...

7. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00043-4/fulltext

Efficacy and safety of brexpiprazole in adolescents with ... Brexpiprazole demonstrated statistically significantly greater reductions in the severity of schizophrenia symptoms over 6 weeks than placebo.

8. psychiatrist.com psychiatrist.com/pcc/outcomes-and-treatment-response-in-schizophrenia/

A Real-World Assessment of Outcomes in Schizophrenia ... Objective: To describe and compare demographics, outcomes, and comorbidities among schizophrenia patients according to treatment response.