Clinical trial NCT06865937: Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
Official title: Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophenia Disorder
Schizoaffective Disorder
Keywords: schizophrenia
serious mental illness
mSITE
randomized clinical trial
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 CBT 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.

Primary outcomes:
measure: Ecological Momentary Assessment
timeFrame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
measure: Clinical Assessment Interview for Negative Symptoms
timeFrame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
measure: Birchwood Social Functioning Scale
timeFrame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
measure: Positive And Negative Syndrome Scale
timeFrame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
measure: Passive sensing mobile application
timeFrame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Eric Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References: