RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-01
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07098169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
  2. 2. Age 18 to 65;
  3. 3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
  4. 4. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
  5. 5. 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;
  6. 6. 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
  7. 7. Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.
  1. 1. Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item \>5)
  2. 2. DSM-5 alcohol or substance dependence in past 3 months based on interview
  3. 3. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.

Contacts and Locations

Study Contact

Colin A Depp, Ph.D.
CONTACT
858-822-4251
cdepp@ucsd.edu
Nikki Abaya, MA
CONTACT
(858) 869 0031
niabaya@health.ucsd.edu

Principal Investigator

Amy Pinkham, PhD
PRINCIPAL_INVESTIGATOR
University of Texas at Dallas

Study Locations (Sites)

UC San Diego
San Diego, California, 92093
United States
University of Miami
Miami, Florida, 33146
United States
University of Texas at Dallas
Dallas, Texas, 75080
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Amy Pinkham, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Dallas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • Digital health
  • Cognitive training
  • Schizophrenia
  • Psychosis
  • Functional rehabilitation

Additional Relevant MeSH Terms

  • Schizophrenia Disorders
  • Schizoaffective Disorder
  • Psychotic Disorder