Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UC San Diego
RECRUITING
San Diego
Florida
University of Miami
RECRUITING
Miami
Texas
University of Texas at Dallas
RECRUITING
Dallas
Contact Information
Primary
Colin A Depp, Ph.D.
cdepp@ucsd.edu
858-822-4251
Backup
Nikki Abaya, MA
niabaya@health.ucsd.edu
(858) 869 0031
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 201
Treatments
Experimental: iTEST
iTEST includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. ITEST also includes daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants guess the number correct after each task and are provided feedback on the accuracy of their guesses. These tasks occur once per day days per week and continue occur over 12 weeks.
Active_comparator: Active Control
The control condition includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. Participants also complete daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants are provided feedback their performance. These tasks occur once per day days per week and continue occur over 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: University of Miami, The University of Texas at Dallas, National Institute of Mental Health (NIMH)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov