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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.

Study design
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.
What's involved
Participants will attend weekly, in-person sessions for 8 weeks, followed by 15-minute remote coaching sessions for 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your social interactions and symptoms will be assessed at the beginning of the study, and again at weeks 8, 18, and 30.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06865937

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

Recruiting
NAAges 18–65InterventionalTreatment
University of California, San Diego
~125 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)Supportive Contact (SC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ecological Momentary Assessment
Measured over Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
+4 more outcomes measured

Conditions

Schizophenia Disorder
Schizoaffective Disorder

Explore related trials

Bipolar I disorderSchizoaffective DisorderSchizophreniaUnipolar Depression

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Eric Granholm, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Jason Holden, PhD
[email protected]
858-246-2517
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Ecological Momentary AssessmentAssess 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 SymptomsAssess 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 ScaleAssess 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 ScaleAssess 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 applicationAssess 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.