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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Mood Disorder, Psychotic
• Intervention / Treatment: Behavioral: mobile Social Interaction Therapy by Exposure (mSITE)

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Eric Granholm, PhD, University of California, San Diego; San Diego Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mood Disorders; Mental Disorders; Affective Disorders, Psychotic
• Other Study ID Numbers: R61MH126094 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).
• IPD Sharing Time Frame: Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.
• IPD Sharing Access Criteria: Data access is outlined in the current NDA Policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No