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NCT06865937NARecruiting

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

University of California, San Diego

Start Date

7/1/2025

Completion Date

9/30/2028

Summary

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.

Detailed 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 Criteria

Age Range: 18 years to 65 years

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.

Interventions

BEHAVIORAL

Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)

BEHAVIORAL

Supportive Contact (SC)

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Conditions

Schizophenia DisorderSchizoaffective Disorder

Locations

University of California - San Diego

San Diego, California 92093

United States