Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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.
Trial design
Treatments tested in this trial
- iTEST
- Active Control
Treatment groups
201 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Diego
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
The University of Texas at Dallas
Collaborator
University of Miami
Collaborator
Source ClinicalTrials.gov