Motivation and Skills Support (MASS)

NCT ID: NCT03404219

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-05-11

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Mobile intervention (i.e., Ecological momentary intervention \[EMI\]) addressing social motivation and social skills. Twice daily notifications sent to deliver EMI content. Social goal reminders and steps provided to support goal attainment. Social Skills Training content delivered via brief video clips.

Group Type: EXPERIMENTAL

Motivation and Skills Support (MASS)

Intervention Type: BEHAVIORAL

Mobile phone-based application to support social skills and social motivation

Interventions

Motivation and Skills Support (MASS)

Mobile phone-based application to support social skills and social motivation

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Francisco State University

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Daniel Fulford

Assistant Professor, Occupational Therapy and Rehabiltiation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Fulford, PhD

Role: PRINCIPAL_INVESTIGATOR

CRC BU Univeristy

Locations

San Francisco State University

San Francisco, California, United States

Boston University

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34128812 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21MH111501-01

Identifier Type: NIH

Identifier Source: org_study_id

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