Motivation and Skills Support (MASS)

NCT03404219 | Completed Results

• 1 other identifier: 1R21MH111501-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• Changes in Social Functioning as Measured by the Social Functioning Scale (SFS)

  The Social Functioning Scale (SFS; Birchwood, Smith, Cochrane, Wetton, and Copestake, 1990) is a validated measure of social functioning commonly used in schizophrenia research studies. This clinician-administered measure consists of 7 sub-scales where higher scores indicate better social functioning: Social Engagement/Withdrawal (7 items. Score range: 0-15), Interpersonal (5 items. Score range: 0-30), Prosocial (5 items. Score range: 0-66), Recreation (23 items. Score range: 0-48), Independence - competence (15 items. Score range: 0-39), Independence - performance (13 items. Score range: 0-39), and Employment (13 items. Score range is 0-6 if the participant is unemployed and 7-10 if the participant is employed). The total score is the sum of the 7 sub-scales (Possible range of 0-247) and higher scores indicate better functioning. The investigators will examine the difference in total score from baseline (study entry) to follow-up (3 months after study termination).

  Baseline (study entry) and follow-up (3 months post-intervention)

• Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale.

  The Heinrich Quality of Life Scale - Interpersonal Relations subscale (Heinrichs, Hanlon, \& Carpenter, 1984) is a validated measure of social engagement used in studies of schizophrenia. This clinician-administered measure consists of 8 items that address different facets of social engagement (e.g., social network, acquaintances, intimate relationships, social withdrawal). Possible scores range from 0-48 with higher scores indicating better outcomes. The investigators will administer this measure at baseline (study entry) and follow-up (3 months post-intervention).

  Baseline (study entry) and follow-up (3 months post-intervention)

Secondary Outcomes (1)

• Changes in Experience-Sampling-Based Self-Reports of Social Appraisals

  2 times per day for 2 months (intervention period).

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Motivation and Skills Support (MASS)

Interventions

Motivation and Skills Support (MASS) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• San Francisco State University: collaborator

Study Sites (2)

San Francisco State University

San Francisco, California, 94132, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 34128812 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Daniel Fulford
• Organization: Boston University

dfulford@bu.edu

(617) 358-6723

Study Officials

• Daniel Fulford, PhD

  CRC BU Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Occupational Therapy and Rehabiltiation Sciences

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: November 1, 2018
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Locations

US (2)