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Search / Trial NCT06865937

Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Mar 4, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Schizophrenia Serious Mental Illness M Site Randomized Clinical Trial

ClinConnect Summary

This clinical trial is studying a new mobile program called Social Interaction Therapy by Exposure (mSITE), designed to help people with serious mental illnesses, like schizophrenia and schizoaffective disorder, engage more socially. The goal is to see if this technology-supported approach can improve social interactions and help individuals feel less isolated.

To participate, people need to be between 18 and 65 years old and have a diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or major depression with a history of psychosis. They should also be willing to read and understand materials in English and score a certain level of social avoidance on a specific assessment. However, those who have received certain types of therapy recently, have severe disorganization in their thoughts, or struggle with substance dependence may not be eligible. This trial is not yet recruiting participants, but those who join can expect to engage with the program using a mobile device to improve their social skills and interactions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
  • Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
  • Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
  • Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).
  • Exclusion Criteria:
  • Prior CBT in the past 2 years;
  • Greater than moderate disorganization on the PANSS (P2- Disorganization item \>5);
  • Alcohol or substance dependence in past 3 months based on the diagnostic interview;
  • Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
  • Unable to adequately see or manually manipulate a phone;
  • Resident of an integrated housing facility that also provides treatment services.

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

Patients applied

0 patients applied

Trial Officials

Eric Granholm, PhD

Principal Investigator

University of California, San Diego

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported