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

Conditions

• Psychotic Disorder
• Schizoaffective Disorder
• Schizophrenia Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• iTEST — BEHAVIORAL
  iTEST 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 — BEHAVIORAL
  Behavioral: 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

Study Details

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.

Key Dates

Start date

Sep 1, 2025

Status verified

Jan 2026

Primary completion

Feb 1, 2028

Completion

Apr 1, 2028

Study Design

Enrollment

201 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Informant-Rated Specific Level of Function (SLOF) Scale [ Time Frame: Change from baseline to 3 month follow up ]

Central Contacts

• Colin A Depp, Ph.D.
  858-822-4251
  [email protected]
• Nikki Abaya, MA
  (858) 869 0031
  [email protected]

Locations (3)

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