[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06865937":3,"trial-entities:NCT06865937":109,"trial-summary:NCT06865937":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":79,"locations":82,"central_contacts":98,"overall_officials":104,"references":107,"see_also_links":108},"NCT06865937","R33MH126094","Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)","RECRUITING","2028-09-30","2026-02","2026-02-23","2025-07-01","University of California, San Diego","OTHER",true,"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.","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.",[18,19],"Schizophenia Disorder","Schizoaffective Disorder",[21,22,23,24],"schizophrenia","serious mental illness","social engagement","randomized clinical trial","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},125,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"mobile Social Interaction Therapy by Exposure (mSITE)",{"type":34,"name":40,"description":41,"armGroupLabels":42},"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.",[40],[44,48,51,54,57],{"measure":45,"description":46,"timeFrame":47},"Ecological Momentary Assessment","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.","Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.",{"measure":49,"description":50,"timeFrame":47},"Clinical Assessment Interview for Negative Symptoms","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.",{"measure":52,"description":53,"timeFrame":47},"Birchwood Social Functioning Scale","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\u002FEmployment 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\u002FRelationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation\u002FEmployment (0-10). Higher scores indicate better functioning for all subscales.",{"measure":55,"description":56,"timeFrame":47},"Positive And Negative Syndrome Scale","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.",{"measure":58,"description":59,"timeFrame":47},"Passive sensing mobile application","The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.",[],"ALL","18 Years","65 Years",false,{"inclusion":66,"exclusion":71,"raw_text":78},[67,68,69,70],"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).",[72,73,74,75,76,77],"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.","Inclusion Criteria:\n\n* Voluntary informed consent to participate and capacity to consent; Age 18 to 65;\n* Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;\n* Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;\n* Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).\n\nExclusion Criteria:\n\n* Prior cognitive-behavioral therapy in the past 2 years;\n* Greater than moderate disorganization on the PANSS (P2- Disorganization item \\>5);\n* Alcohol or substance dependence in past 3 months based on the diagnostic interview;\n* Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);\n* Unable to adequately see or manually manipulate a phone;\n* Resident of an integrated housing facility that also provides treatment services.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"University of California - San Diego","San Diego","California","92093","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Jason Holden, PhD","CONTACT","858-246-2517","jlholden@health.ucsd.edu",{"lat":96,"lon":97},32.71571,-117.16472,[99,100],{"name":91,"role":92,"phone":93,"email":94},{"name":101,"role":92,"phone":102,"email":103},"Eric Granholm, PhD","858-534-2542","egranholm@health.ucsd.edu",[105],{"name":101,"affiliation":12,"role":106},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":114},[111,19,112,113],"Bipolar I disorder","Schizophrenia","Unipolar Depression",[],{"nct_id":4,"found":14,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a randomized clinical trial, meaning participants will be assigned by chance to either the mSITE or Supportive Contact group. The study plans to enroll 125 participants.","completed","Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE) for Schizophrenia and Schizoaffective Disorder","This study is testing a new approach called mSITE (Mobile Intervention for Social Recovery in Serious Mental Illness) to help people with schizophrenia or schizoaffective disorder improve their social interactions. mSITE combines brief in-person therapy with a smartphone app that gives support when you need it, and remote coaching over the phone. We're comparing mSITE to a similar program called Supportive Contact (SC). We want to see if mSITE helps people have more social interactions. You may be able to join if you are 18-65 years old, have a diagnosis of schizophrenia or schizoaffective disorder, and experience a certain level of social avoidance. The study aims to enroll 125 people, but its current status is unclear.","Your social interactions and symptoms will be assessed at the beginning of the study, and again at weeks 8, 18, and 30.",116,"Participants will attend weekly, in-person sessions for 8 weeks, followed by 15-minute remote coaching sessions for 10 weeks.","Not stated in the trial record.",[40],"v2"]