Clinical trial NCT05899348: iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
Official title: iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Psychotic Disorders
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The University of Texas at Dallas
name: University of Miami
First posted: 2023-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: People with psychotic disorders experience a high level of functional disability, and a major contributor to this disability is introspective accuracy, which is defined as inaccurate judgements of one's abilities and performance on tasks. Yet, no intervention has directly targeted introspective accuracy for psychotic illnesses. This trial will evaluate a new intervention, called iTEST, that uses mobile devices to train people with psychotic disorders to improve introspective accuracy and, ultimately, functional outcomes

Detailed description: This NIH-supported clinical trial is the first phase of a two phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal is to evaluate a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, with the ultimate goal of improving functional outcome. 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. This project's premise is that task-based IA training could be delivered in a remote mobile health format and coupled with coaching in applying improved IA to real-world functional behaviors, creating a novel avenue for functional rehabilitation in psychotic disorders. 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 phase trial here, the investigators will recruit people with psychotic disorders with at least minimal functional impairment. The investigators will conduct an open trial of iTEST, evaluating whether the intervention leads to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). The investigators will also determine the dose of intervention needed to achieve clinically significant improvement in IA targets, by evaluating change at 8, 12, or 16 weeks. The go/no go criteria for this trial are 75% adherence and clinically significant increases in introspective accuracy. A total of 60 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial

Eligibility criteria: Inclusion Criteria:

1. Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
2. Age 18 to 65;
3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
4. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
5. 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;
6. 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
7. Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.

Exclusion Criteria:

1. Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5)
2. DSM-5 alcohol or substance dependence in past 3 months based on interview
3. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.

Primary outcomes:
measure: Trained Introspective Accuracy
timeFrame: Change from Baseline to 16 week follow up assessment
measure: Untrained Introspective Accuracy on WCST
timeFrame: Change from Baseline to 16 week follow up assessment
measure: Adherence
timeFrame: Change over 16 weeks
Secondary outcomes:
measure: Specific Level of Function Scale (Informant Version)
timeFrame: Change from Baseline Assessment to 16 week follow up Assessment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
References: