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

University of California San Diego

Status: Enrolling

Conditions: Schizophenia Disorder; Schizoaffective Disorder

Treatments: Behavioral: Supportive Contact (SC); Behavioral: Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06865937

4R33MH126094-03 (U.S. NIH Grant/Contract)

R33MH126094 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

mobile Social Interaction Therapy by Exposure (mSITE)

Experimental group

Description:

mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.

Treatment:

Behavioral: Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)

Supportive Contact (SC)

Active Comparator group

Description:

The SC arm is a contact condition that will provide the same amount of individual in-person and coaching, and mobile device contact as the mSITE condition.

Treatment:

Behavioral: Supportive Contact (SC)