What this study is
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.
What's being tested
- Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)
Intervention · 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)
Intervention · 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
- Sponsor
- University of California, San Diego
- Conditions
- Schizophenia Disorder · Schizoaffective Disorder
- Enrolling
- 125 people
- Starts
- 2025-07-01
- Est. completion
- 2027-09-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California - San Diego
San Diego, California, United States
- Jason Holden, PhD · Contact858-246-2517jlholden@health.ucsd.edu
Recruiting
Study team
Sponsor
University of California, San Diego
Study ID R33MH126094
Principal investigator
Eric Granholm, PhD
University of California, San Diego
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.