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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06865937
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE) — BEHAVIORAL
    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.
  • Supportive Contact (SC) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mobile Social Interaction Therapy by Exposure (mSITE)
    mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.
  • Active Comparator: Supportive Contact (SC)
    The SC arm is a contact condition that will provide the same amount of individual in-person and coaching, and mobile device contact as the mSITE condition.

Primary Outcome Measure

Ecological Momentary Assessment [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California - San DiegoSan DiegoCalifornia92093
Jason Holden, PhD
858-246-2517

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