Clinical trial NCT03404219: Motivation and Skills Support (MASS)
Official title: Enhancing Social Functioning in Schizophrenia Through Scalable Mobile Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: San Francisco State University
First posted: 2018-01-19
Enrollment: 31
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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Social impairment contributes to more severe symptoms, higher rates of hospitalization, and increased disability in persons with schizophrenia. In this study the investigators will develop a smartphone application and test its impact on improving real-world social functioning in persons with schizophrenia. Findings from this study will allow researchers and clinicians to better understand ways to improve social skills and social motivation, two common problems in the daily lives of persons with schizophrenia. The investigators hope this mobile phone-based support application will ultimately contribute to increased access to effective treatments for social functioning in this population.

Detailed description: This project will involve an examination of the impact of a mobile intervention to improve social functioning in schizophrenia using an evidence-based treatment framework to target deficits in social skills and social motivation. Social impairment is a key characteristic of schizophrenia, present prior to onset and predictive of long-term course. The approach of the current project is to use Ecological Momentary Intervention (EMI), administered by mobile phone, to integrate features from social skills training (SST; an evidence-based treatment for schizophrenia) with social motivation support to improve social functioning. Aim 1 of the project will involve iterative development of the mobile application, using expert panel input and conducting usability testing to inform intervention content and approach. As an exploratory aim, social sensing technology (e.g., GPS and automated conversation detection) will be implemented to test the promise of this technology in identifying and intervening in social isolation. In Aim 2, 30 persons with schizophrenia will use the application over a 2-month period (data collection will occur across 2 sites). The investigators will test the impact of the application on social motivation (EMA reports of social anticipatory pleasure and presence of social interaction) across the intervention period. Investigators will also examine the impact on social functioning, measured with standard clinician-administered assessments, from baseline to 90-day follow-up. Additional clinical, neurocognitive, and social cognitive assessments will be gathered on study participants to identify potential moderators of outcome and predictors of application usability. This study will result in a better understanding of the feasibility and initial impact of a scalable intervention designed to support lasting, sustainable improvements in social functioning in schizophrenia.

Eligibility criteria: Inclusion Criteria:

•All participants with schizophrenia or schizoaffective disorder (identified either by self-report and confirmatory chart diagnosis, or by using the Structured Clinical Interview for DSM-5 \[SCID-5\]) will be in good general physical health, between 18 and 65 years old (as to not confound developmental issues with our focus), and fluent in English. Subjects do not need to have a significant other in order to participate in the study.

Exclusion Criteria:

•All participants with a current (past 6 months) substance use disorder, which will be determined by administration of the SCID-5, and self-reported current suicidal ideation with intent and/or a plan (assessed using attached instrument; i.e., "High" risk) or diagnosis of a neurological disorder.

Primary outcomes:
measure: Changes in Social Functioning as Measured by the Social Functioning Scale (SFS)
timeFrame: Baseline (study entry) and follow-up (3 months post-intervention)
measure: Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale.
timeFrame: Baseline (study entry) and follow-up (3 months post-intervention)
Secondary outcomes:
measure: Changes in Experience-Sampling-Based Self-Reports of Social Appraisals
timeFrame: 2 times per day for 2 months (intervention period).
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco State University
state: California
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: CRC BU Univeristy
name: Daniel Fulford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fulford D, Gard DE, Mueser KT, Mote J, Gill K, Leung L, Mow J. Preliminary Outcomes of an Ecological Momentary Intervention for Social Functioning in Schizophrenia: Pre-Post Study of the Motivation and Skills Support App. JMIR Ment Health. 2021 Jun 15;8(6):e27475. doi: 10.2196/27475.