Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
Recruiting · NCT07098169 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
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
- Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
Where it is running
3 locations listed across 3 US states.
- UC San Diego - San Diego, California, United States
- University of Miami - Miami, Florida, United States
- University of Texas at Dallas - Dallas, Texas, United States