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

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.

Conditions

• Schizophrenia Disorders
• Schizoaffective Disorder
• Psychotic Disorder

Interventions

BEHAVIORAL

iTEST

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

BEHAVIORAL

Active Control

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• The University of Texas at Dallas

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Amy Pinkham, PhD · University of Texas at Dallas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2028-02-01

Completion

2028-04-01

Countries

• United States

Study Locations