Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Context-aware mobile program to boost social recovery in serious mental illness

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

Run by University of California, San Diego · NCT06865937 · Data updated 2026-11-12

This project will test a blended mobile and in-person therapy called mSITE to help adults with schizophrenia or schizoaffective disorder increase how often they interact with other people.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment125 (estimated)
SponsorUniversity of California, San Diego
Academic / other
Locations1 site (San Diego, California)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedSeptember 30, 2028
Study endsSeptember 30, 2028
Registry record updatedFebruary 23, 2026
Trial IDNCT06865937 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with schizophrenia or schizoaffective disorder who can give informed consent, read English at about a sixth-grade level, report measurable social avoidance (SANS asociality ≥ 2), and can use a smartphone are ideal candidates.

Probably not a fit

Patients who recently received cognitive-behavioral therapy, have marked disorganization, current substance dependence, need a level of care that prevents outpatient participation, cannot use a phone, or live in certain integrated housing settings may not benefit from or be eligible for the intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial tests mSITE, a blended intervention combining brief in-person psychotherapy, context-triggered smartphone prompts, and remote telephone coaching to target social engagement in people with serious mental illness. Participants are randomized to receive mSITE or a therapist-and-device-matched Supportive Contact (SC) condition. Outcomes focus on changes in the frequency of real-world social interactions measured at baseline and at Weeks 8, 18, and 30, and the study also validates new digital techniques for measuring social behavior. The work is conducted at the University of California San Diego and uses smartphone-based context awareness to deliver just-in-time supports.

Why it matters

Potential benefit: If effective, mSITE could reduce social isolation and increase real-world social activity, improving daily functioning and quality of life for people with serious mental illness.

How similar studies have gone: Some prior CBT and mobile-support interventions have shown modest gains in social functioning, but context-aware blended approaches like mSITE are relatively novel and not yet widely tested.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University of California - San Diego
    San Diego, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.