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

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

Recruiting
18-65 years
All
Phase N/A

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Overview

This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

Description

This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with a context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct a randomized clinical trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions in comparison to a therapist and device matched condition. The investigators will changes in outcome measures at baseline and Weeks 8, 18, and 30. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.

Eligibility

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 cognitive-behavioral therapy 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.

Study details
    Schizophenia Disorder
    Schizoaffective Disorder

NCT06865937

University of California, San Diego

1 February 2026

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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