iTEST for Psychotic Disorders

(iTEST Trial)

No longer recruiting at 1 trial location

Overseen By Colin Depp, Ph.D.

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: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called iTEST, designed to improve introspective accuracy in people with psychotic disorders. Introspective accuracy refers to how well someone can assess their own abilities and performance. The goal is to reduce daily functional challenges for those with schizophrenia or schizoaffective disorder. Suitable participants should have one of these conditions, be stable with current treatments, and not be fully employed. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance daily life for many.

Do I have to stop taking my current medications?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your treatments have been stable for at least 2 months before joining. This means no recent hospitalizations or changes in medication type.

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

Research has shown that iTEST is a new method designed to help people with psychotic disorders better understand and evaluate their own skills and performance. Since iTEST is a new treatment, detailed safety information is limited. However, the trial's "Not Applicable" phase indicates that researchers are closely monitoring safety, even if comprehensive safety data is not yet available.

For those considering joining the trial, it's important to know that while iTEST is experimental, it focuses on improving thinking and self-assessment using mobile devices. This non-invasive approach generally suggests minimal physical risk, though individual experiences may vary. Discuss potential risks and benefits with trial coordinators or a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iTEST for psychotic disorders because it represents a novel approach in managing these conditions. Traditional treatments often rely on antipsychotic medications, which primarily target dopamine pathways. However, iTEST is distinct as it leverages cutting-edge technology to potentially provide personalized, non-pharmacological interventions. This method could offer a new avenue for treatment that may reduce side effects associated with conventional medications and enhance patient outcomes through tailored therapeutic strategies.

What evidence suggests that iTEST is effective for improving introspective accuracy in psychotic disorders?

Research shows that the iTEST program, provided to participants in this trial, helps individuals with psychotic disorders better understand their abilities and performance. This self-awareness, known as introspective accuracy, can lead to improved daily functioning, as studies suggest. The tasks in iTEST have remained consistent over time and resemble those used in research labs. Although direct evidence on iTEST's effectiveness is still being gathered, the approach is based on promising research into enhancing thinking and daily skills in people with psychosis. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 65 with schizophrenia or schizoaffective disorder, who can make informed decisions and have a contact person involved in their care. They should be able to read at a 6th-grade level and have stable treatments with no recent hospitalizations or medication changes. Participants must not be fully employed or financially independent due to their condition.

Inclusion Criteria

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)

I have some difficulty with daily activities but am not working full-time or paying for my household.

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 attending outpatient therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iTEST intervention, which includes mobile device training and personalized coaching to improve introspective accuracy

16 weeks

Daily mobile prompts

Follow-up

Participants are monitored for changes in introspective accuracy and functional outcomes

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iTEST

Trial Overview The iTEST intervention uses mobile devices to help people with psychotic disorders improve how accurately they judge their own abilities and task performance. The goal is to enhance daily functioning by training introspective accuracy through the use of these devices.

How Is the Trial Designed?

Group I: iTEST Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 3074 patients diagnosed with acute and transient psychotic disorders (ATPD), 46.25% developed persistent psychotic disorders within 8 years, highlighting a significant long-term risk associated with ATPD.

The cumulative risk of developing schizophrenia-spectrum disorders was particularly high, at 36.14% after 8 years, suggesting that early detection and preventive treatments could be crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term outcomes of acute and transient psychotic disorders: The missed opportunity of preventive interventions. Rutigliano, G., Merlino, S., Minichino, A., et al.[2021]

In a study monitoring 86,439 patients treated with neuroleptics from 1993 to 2000, severe adverse drug reactions (ADRs) occurred in 1.1% of patients, with atypical neuroleptics causing more severe ADRs than typical ones, primarily due to clozapine-related issues.

When excluding clozapine, typical and atypical neuroleptics showed similar rates of severe ADRs, but their profiles differed, highlighting the importance of considering real-life ADR data for better treatment decisions in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe adverse drug reactions in psychiatric inpatients treated with neuroleptics. Bender, S., Grohmann, R., Engel, RR., et al.[2007]

A total of 45,201 adverse drug reactions (ADRs) were reported in children and adolescents treated with antipsychotics, with the most common being extrapyramidal syndrome (14.7%), breast disorders or changes in blood prolactin levels (4.7%), and cardiac arrhythmias (4.6%).

Differences in ADR reporting frequencies were noted between age groups and types of reporters, indicating that younger children (ages 1-5) reported fewer cases of hyperglycemia/new-onset diabetes compared to older adolescents (ages 12-17), which can help in tailoring monitoring and information about potential ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics. Minjon, L., van den Ban, E., de Jong, E., et al.[2020]

Integrated Psychological Therapy (IPT) was found to be more effective for individuals with nontreatment resistant schizophrenia (NTRS) compared to those with treatment-resistant schizophrenia (TRS), based on a study involving 48 outpatients over a 10-week therapy period.

While IPT showed some improvements in TRS patients that were maintained at follow-up, the overall effectiveness of IPT was significantly higher in NTRS patients, indicating that different approaches may be needed for varying types of schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Psychological Therapy and Treatment-Resistant Schizophrenia: Initial Findings. Rakitzi, S., Georgila, P.[2020]

In a study of 80 individuals with schizophrenia, patients prioritized the treatment of affective and neuropsychological symptoms over positive symptoms, highlighting the need for a more holistic approach to treatment.

Patients found therapies like Talk, Psychoanalytic, and Art Therapy, as well as Metacognitive Training, to be the most helpful, suggesting that clinicians should align treatment plans with patient preferences to improve outcomes and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The customer is always right? Subjective target symptoms and treatment preferences in patients with psychosis. Moritz, S., Berna, F., Jaeger, S., et al.[2018]

In a study involving 40 participants, including 25 with first-episode psychosis (FEP), group cognitive behavioral therapy (CBT) led to significant reductions in positive, depressive, and anxiety symptoms, as well as improved quality of life for both FEP and stable psychosis patients.

Notably, only the FEP group showed improvement in negative symptoms, suggesting that early intervention with CBT may be particularly beneficial for addressing these challenging symptoms in psychotic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy as a treatment for negative symptoms in first-episode psychosis. Gaynor, K., Dooley, B., Lawlor, E., et al.[2018]

Pisa syndrome, a rare side effect of neuroleptic medications, was documented in 20 episodes among 17 patients in a study of 45,000 psychiatric patients, indicating its low frequency but potential risk in certain populations.

Risk factors for developing Pisa syndrome include previous treatment with classical neuroleptics, combined pharmacologic treatment, being female, older age, and having an organic brain disorder, suggesting that these patients require careful monitoring when prescribed neuroleptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pisa syndrome (pleurothotonus): report of a multicenter drug safety surveillance project. Stübner, S., Padberg, F., Grohmann, R., et al.[2004]

Olanzapine demonstrated statistically significant improvements in both efficacy and safety compared to risperidone in treating schizophrenia, based on a meta-analysis of randomized, double-blind studies.

The analysis showed that olanzapine was associated with fewer anticholinergic side effects and lower dropout rates, indicating it may enhance patient quality of life and treatment adherence over both short (≤12 weeks) and longer-term (>12 weeks) periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of olanzapine versus risperidone for the treatment of schizophrenia: a meta-analysis of randomised clinical trials. Mudge, MA., Davey, PJ., Coleman, DK., et al.[2014]

In a systematic review of 15 short-term trials involving 2208 children and adolescents, clozapine, molindone, olanzapine, and risperidone were found to be the most effective antipsychotics for reducing psychosis symptoms, with clozapine showing the highest effect size.

Long-term treatment evidence was limited, with only lurasidone demonstrating effectiveness, while clozapine and haloperidol were associated with significantly higher dropout rates due to adverse events, highlighting the need for more comprehensive trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy and Tolerability of Antipsychotics for Juvenile Psychotic Disorders: A Systematic Review and Network Meta-Analysis. Yee, CS., Bahji, A., Lolich, M., et al.[2022]

A new set of patient-reported outcome measures was developed for adolescents and adults with psychotic disorders, focusing on four key domains: symptoms, recovery, functioning, and treatment, based on input from over 100 stakeholders.

The final outcome set includes nine measures that can be completed in about 35 minutes, is free for users, available in multiple languages, and aims to enhance clinical decision-making and program evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an International Standard Set of Patient-Reported Outcome Measures for Psychotic Disorders. McKenzie, E., Matkin, L., Sousa Fialho, L., et al.[2022]

Psychotherapy is effective for individuals with psychotic disorders, helping to reduce symptoms and improve overall quality of life, as supported by international guidelines.

Cognitive-behavioral therapy, family interventions, and psychoeducation are particularly beneficial, but successful treatment relies on a strong therapeutic relationship and coordination with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy of psychotic disorders]. Lamster, F., Jäger, M.[2018]

In a study of 73 first-hospitalized patients with acute and transient psychotic disorders, 42% did not experience any relapses over a follow-up period of three to seven years, indicating a favorable long-term outcome for many individuals.

However, 12% of patients experienced relapses that led to severe social impairment, suggesting that these cases may represent an early indication of a chronic condition rather than a transient disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Course and outcome of first-admitted patients with acute and transient psychotic disorders (ICD-10:F23). Focus on relapses and social adjustment. Jäger M D, M., Hintermayr, M., Bottlender, R., et al.[2009]

In a 2-year study of 68 patients with first-episode acute and transient psychotic disorders (ATPD), 55.9% showed diagnostic stability by the end of the follow-up, indicating a significant portion of patients may have consistent diagnoses over time.

Key predictors of diagnostic stability included the presence of motility disturbances, and the absence of hallucinations and schizophrenic features, suggesting that these factors could help identify patients whose ATPD diagnosis is likely to remain stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic role of catatonia, hallucinations, and symptoms of schizophrenia in acute and transient psychosis. López-Díaz, Á., Fernández-González, JL., Lara, I., et al.[2020]

The incidence of acute and transient psychotic disorders (ATPDs) was found to be 6.7 per 100,000 person-years, with no significant gender differences, indicating a relatively common occurrence in the population.

Among ATPD subtypes, polymorphic psychotic disorder was more prevalent in females, while those with schizophrenic symptoms were more common in younger males, suggesting distinct demographic patterns that may inform future diagnostic criteria revisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in incidence and age of onset of acute and transient psychotic disorders. Castagnini, A., Foldager, L.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05899348

iTEST: Introspective Accuracy as a Novel Target for ... People with psychotic disorders experience a high level of functional disability, and a major contributor to this disability is introspective accuracy, ...

2. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT07098169

iTEST: A Blended Intervention Targeting Introspective Accuracy The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets ...

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

Protocol for evaluation of iTEST, a novel blended ... These tasks were selected for iTEST because studies have shown that average performance remains stable over time, they correlate with in-lab ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01321177

An Integrated Program for the Treatment of First Episode ... The ETP study aims to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis.

5. mdpi.com mdpi.com/2077-0383/14/15/5521

A Systematic Review and Meta-Regression Analysis Background: Cognitive behavioral therapy (CBT) has shown consistent efficacy in individuals with psychosis, as supported by many trials.

6. nature.com nature.com/articles/s44277-024-00024-7

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 ...

7. 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, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39959603/

Protocol for evaluation of iTEST, a novel blended intervention ... We describe a protocol for a clinical trial to test a newly developed blended digital intervention, Improving Thinking through Everyday SelfAssessment Training ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2950285324000528

Individualized pretest risk estimates to guide treatment ... Original. Individualized pretest risk estimates to guide treatment decisions in patients with clinical high risk for psychotic disorders.

10. mdpi.com mdpi.com/2076-3425/14/9/878

Prediction of Clinical Outcomes in Psychotic Disorders ... The clinical outcomes included symptomatic improvements, illness course, and social functioning. The machine learning models utilized data from ...