What side effects are associated with this type of intervention?

Common treatments for psychosis include antipsychotic medications and cognitive-behavioral therapies (CBT). Antipsychotic medications, such as atypical antipsychotics, can cause side effects like weight gain, drowsiness, and long-term memory impairments. Cognitive-behavioral therapies, including those delivered via mobile devices like the iTEST intervention, generally have fewer physical side effects but may cause initial discomfort as patients confront distressing thoughts and behaviors. Overall, while pharmacological treatments have more pronounced physical side effects, non-pharmacological approaches focus on psychological challenges.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of psychosis, primarily focusing on antipsychotic drugs. These include first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, and aripiprazole. While these medications primarily target symptoms like delusions and hallucinations, there is limited evidence on FDA-approved treatments specifically aimed at improving introspective accuracy. Cognitive Behavioral Therapy (CBT) has been used to help patients manage delusions and hallucinations by improving their reality testing and cognitive restructuring, which aligns with the goals of the iTEST trial. However, no mobile device-based training interventions have been FDA-approved for this purpose to date.

What other types of research exist?

Promising, novel alternatives to iTEST for psychosis patients include: 1) Texting 4 Relapse Prevention (T4RP), a text messaging-based relapse prevention program for schizophrenia and schizoaffective disorder, which has shown high patient acceptability and positive outcomes in recovery and patient-provider communication. 2) Smartphone-assisted guided self-help cognitive behavioral therapy (CBTv) for distressing voices, which uses Ecological Momentary Assessment Intervention (EMI) to deliver therapy and has shown efficacy in youth with distressing voices.

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Behavioral Intervention

iTEST for Psychotic Disorders (iTEST Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests iTEST, a mobile-based program designed to help people with schizophrenia or schizoaffective disorder improve their self-assessment skills and apply them to daily life. The goal is to reduce disability by enhancing their ability to judge their own abilities accurately.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since iTEST is a non-medical intervention involving training on mobile devices, traditional side effects associated with medications are not expected. However, participants may experience frustration or stress if they find the tasks challenging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Trained Introspective Accuracy

Untrained Introspective Accuracy on WCST

Secondary study objectives

Specific Level of Function Scale (Informant Version)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: iTESTExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for psychosis include antipsychotic medications, cognitive-behavioral therapy (CBT), and psychoeducation. Antipsychotic medications work by altering the effects of neurotransmitters in the brain, particularly dopamine, to reduce symptoms like hallucinations and delusions. CBT helps patients by addressing distorted thinking patterns and improving coping strategies. Psychoeducation provides patients and their families with information about the disorder and its management. The iTEST trial focuses on improving introspective accuracy using mobile devices, which is crucial for psychosis patients as it can enhance their self-awareness and functional outcomes. Understanding these mechanisms is important because they target different aspects of the disorder, offering a comprehensive approach to treatment and improving overall quality of life for patients.

Relapse prevention in ambulant mental health care tailored to patients with schizophrenia or bipolar disorder.Metacognitive training for schizophrenia: a systematic review.Cognitive behavioral therapy (brief vs standard duration) for schizophrenia.