Clinical trial NCT05660070: Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness
Official title: Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Mood Disorder, Psychotic
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Voluntary informed consent to participate and capacity to consent;
2. Age 18 to 65;
3. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a SCID-5 interview and available medical record review;
4. Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (to read therapy workbook).

Exclusion Criteria:

1. Prior CBT in the past 2 years;
2. Greater than moderate disorganization on the PANSS (P2- Disorganization item \>5);
3. DSM-5 alcohol or substance dependence in past 3 months based on the SCID;
4. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness)
5. Unable to adequately see or manually manipulate a phone;
6. 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, 12, 18, and 24
measure: Clinical Assessment Interview for Negative Symptoms
timeFrame: Assess change from baseline in expression and motivation and pleasure at Weeks 0, 8, 12, 18, and 24
measure: Birchwood Social Functioning Scale
timeFrame: Assess change from baseline in social functioning at Weeks 0, 8, 12, 18, and 24
measure: Positive And Negative Syndrome Scale
timeFrame: Assess change from baseline in positive and negative symptoms at Weeks 0, 8, 12, 18, and 24
measure: Passive sensing mobile application
timeFrame: Assess change from baseline in number of conversations at Weeks 0, 8, 12, 18, and 24
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego; San Diego Veterans Healthcare System
name: Eric Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References: