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This open 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.
Social isolation is common in serious mental illness and has a profound negative impact on recovery. 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 context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct an open trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions. The investigators will also determine the dose of app plus remote coaching necessary to achieve this effect, by evaluating change at 12, 18, or 24 weeks. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile Social Interaction Therapy by Exposure (mSITE) | Experimental | mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile Social Interaction Therapy by Exposure (mSITE) | Behavioral | mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 12, 18, and 24 |
| Clinical Assessment Interview for Negative Symptoms | Measure changes in motivational negative symptoms on the 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. | Assess change from baseline in expression and motivation and pleasure at Weeks 0, 8, 12, 18, and 24 |
| 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/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. | Assess change from baseline in social functioning at Weeks 0, 8, 12, 18, and 24 |
| Positive And Negative Syndrome Scale | The 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Granholm, PhD | University of California, San Diego; San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | United States |
Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).
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Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.
Data access is outlined in the current NDA Policy.
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 22, 2026 | |
| Reset | Feb 11, 2026 | |
| Release | Feb 24, 2026 | |
| Reset | Mar 17, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2023 | Jun 12, 2024 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 22, 2026 | Feb 11, 2026 | |||
| Feb 24, 2026 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D000341 | Affective Disorders, Psychotic |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Single Group Assignment
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| Assess change from baseline in positive and negative symptoms at Weeks 0, 8, 12, 18, and 24 |
| Passive sensing mobile application | The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded. | Assess change from baseline in number of conversations at Weeks 0, 8, 12, 18, and 24 |
| Mar 17, 2026 |