NCT06865937 · University of California, San Diego
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
What this study is about
This randomly assigned 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Ecological Momentary Assessment
Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Ecological Momentary Assessment (EMA) is a method of remote data collection that involves repeatedly sampling a participant's current behaviors, thoughts, mood, and experiences in real time, in their natural environments. The primary outcome in this study will be the number of social interactions.
Clinical Assessment Interview for Negative Symptoms
Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Measure changes in motivational negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.
Birchwood Social Functioning Scale
Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Measure changes in functioning on the Birchwood Social Functioning Scale (SFS). The SFS is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3 with the exception of the Occupation/Employment subscale if a participant is in regular employment (scores range from 7-10 based upon type of work). The subscales and score ranges are: Social Engagement Withdrawal (0-15), Interpersonal Communication/Relationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation/Employment (0-10). Higher scores indicate better functioning for all subscales.
Positive And Negative Syndrome Scale
Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
The Positive And Negative Syndrome Scale (PANSS) is a 30-item interview that provides balanced representation of positive and negative symptoms and gauges their relationship to one another and to global psychopathology. Items are rated 1 (Absent) to 7 (Extreme) and summed across items for a total range of scores of 30-210. Higher scores indicate the presence of more severe symptoms.
Passive sensing mobile application
Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Diego, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations