NCT06865937

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophenia Disorder
• Schizoaffective Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)	mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. Participants will attend weekly, in-person sessions for 8 weeks and then 15-minute, remote coaching sessions for 10 weeks. The intervention begins with setting a meaningful recovery goal and then the generic cognitive model is introduced and a simple thought challenging skill is trained to specifically address social avoidance behaviors and facilitate work toward recovery goals. Defeatist attitudes, social threat and avoidance behaviors that interfere with working on the goal are then modified using cognitive-behavioral therapy skills and practiced using role-plays.
BEHAVIORAL	Supportive Contact (SC)	The SC arm will match the mSITE arm on the same amount of individual in-person and coaching, and mobile device contact. Coaching sessions will be semi-structured and consist of setting recovery goals, check-in about symptoms and potential crisis management, flexible discussion involving psychoeducation, instructions for accessing community crisis lines and community resources, and symptom management behaviors that grow out of discussions, with only minimal therapist guidance.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-03-10
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States