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

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06865937 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

San Diego, California

• University of California - San Diego — San Diego, California, United States (Recruiting)

Study contacts

• Principal investigator: Eric Granholm, PhD — University of California, San Diego
• Study coordinator: Jason Holden, PhD

Conditions Schizophenia Disorder; Schizoaffective Disorder; schizophrenia; serious mental illness; social engagement; randomized clinical trial