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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
iTEST
BehavioraliTEST is a computerized training intervention delivered on a mobile device that is coupled with individual contacts with a therapist/coach. The mobile components train in improving participant's ability to form accurate judgments about their performance and their rate of functional activities. The intervention involves coaching coupled with automated training that is delivered on a mobile device. The automated training involves daily cognitive tests in which the goal for treatment is to improve judgments of accuracy of self-assessment, and coaching is aimed at applying improving metacognitive awareness to every day activities. i
Active Control
BehavioralBehavioral: Mobile cognitive tests will be administered to control subjects. Participants will receive feedback regarding their performance but not on the accuracy of their self-ratings. Coaching will also be coupled with mobile cognitive tests and will include goal-setting without specific mention of Introspective Accuracy (IA). in place of content related to IA, participants will receive psychoeducation about the benefits of sleep, physical activity, and social connection to overall cognitive health
Treatment groups
201 Participants
are divided into 2 treatment groupsGroup A: iTESTExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Informant-Rated Specific Level of Function (SLOF) Scale
Measure of participant's community functioning rated by an informant. Scale scores range from 43 to 215 with higher scores reflecting better functioning.
Time frame
Change from baseline to 3 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
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