NCT06865937 Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
| NCT ID | NCT06865937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Schizophenia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2025-07-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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.
Contact & Investigator
Eric Granholm, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06865937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophenia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06865937 currently recruiting?
Yes, NCT06865937 is actively recruiting participants. Contact the research team at jlholden@health.ucsd.edu for enrollment information.
Where is the NCT06865937 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06865937 clinical trial?
NCT06865937 is sponsored by University of California, San Diego. The principal investigator is Eric Granholm, PhD at University of California, San Diego. The trial plans to enroll 125 participants.