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

Schizophrenia Clinical Trial

— mSITE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05660070
• Other study ID #: R61MH126094
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: October 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• mobile Social Interaction Therapy by Exposure (mSITE)
mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.	Assess change from baseline in positive and negative symptoms at Weeks 0, 8, 12, 18, and 24
Primary	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