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Motivation and Skills Support (MASS)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation and Skills Support (MASS)
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco State University
  • Boston University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Changes in Experience-Sampling-Based Self-Reports of Social Appraisals
The investigators will ask participants to report on positive social appraisals (unpublished measure) of recent interactions 2 times per day over the 2-month intervention period. Specific items and response options are the following: "How well do you think you communicated in those conversations?" (from 1 [I did not communicate well at all] to 4 [I communicated very well]) "To what extent were those interactions worth the effort?" (from 1 [not worth the effort at all] to 4 [definitely worth the effort]) "What do you think other people thought of you in those conversations?" with response options ranging from 1 [very unlikable] to 4 [very likable]) We will average scores on the above items across all available time points (total possible time points = 120) to form a composite variable representing social appraisals. Higher scores represent more positive appraisals. Investigators will examine changes in appraisals over the intervention.

Full Information

First Posted
January 12, 2018
Last Updated
July 16, 2021
Sponsor
Boston University Charles River Campus
Collaborators
San Francisco State University
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1. Study Identification

Unique Protocol Identification Number
NCT03404219
Brief Title
Motivation and Skills Support (MASS)
Official Title
Enhancing Social Functioning in Schizophrenia Through Scalable Mobile Technology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
San Francisco State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivation and Skills Support (MASS)
Intervention Description
Mobile phone-based application to support social skills and social motivation
Primary Outcome Measure Information:
Title
Changes in Social Functioning as Measured by the Social Functioning Scale (SFS)
Description
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).
Time Frame
Baseline (study entry) and follow-up (3 months post-intervention)
Title
Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale.
Description
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).
Time Frame
Baseline (study entry) and follow-up (3 months post-intervention)
Secondary Outcome Measure Information:
Title
Changes in Experience-Sampling-Based Self-Reports of Social Appraisals
Description
The investigators will ask participants to report on positive social appraisals (unpublished measure) of recent interactions 2 times per day over the 2-month intervention period. Specific items and response options are the following: "How well do you think you communicated in those conversations?" (from 1 [I did not communicate well at all] to 4 [I communicated very well]) "To what extent were those interactions worth the effort?" (from 1 [not worth the effort at all] to 4 [definitely worth the effort]) "What do you think other people thought of you in those conversations?" with response options ranging from 1 [very unlikable] to 4 [very likable]) We will average scores on the above items across all available time points (total possible time points = 120) to form a composite variable representing social appraisals. Higher scores represent more positive appraisals. Investigators will examine changes in appraisals over the intervention.
Time Frame
2 times per day for 2 months (intervention period).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Fulford, PhD
Organizational Affiliation
CRC BU Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco State University
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34128812
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.
Results Reference
derived

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Motivation and Skills Support (MASS)

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