Motivation and Skills Support (MASS)

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Completed
CT.gov ID
NCT03404219
Collaborator
San Francisco State University (Other)
31
2
1
18.3
15.5
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivation and Skills Support (MASS)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Enhancing Social Functioning in Schizophrenia Through Scalable Mobile Technology
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
May 11, 2020
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Motivation and Skills Support (MASS)
Mobile phone-based application to support social skills and social motivation

Outcome Measures

Primary Outcome Measures

  1. Changes in Social Functioning as Measured by the Social Functioning Scale (SFS) [Baseline (study entry) and follow-up (3 months post-intervention)]

    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).

  2. Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale. [Baseline (study entry) and follow-up (3 months post-intervention)]

    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

  1. Changes in Experience-Sampling-Based Self-Reports of Social Appraisals [2 times per day for 2 months (intervention period).]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Francisco State University San Francisco California United States 94132
2 Boston University Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Boston University Charles River Campus
  • San Francisco State University

Investigators

  • Principal Investigator: Daniel Fulford, PhD, CRC BU Univeristy

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Daniel Fulford, Assistant Professor, Occupational Therapy and Rehabiltiation Sciences, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT03404219
Other Study ID Numbers:
  • 1R21MH111501-01
First Posted:
Jan 19, 2018
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 73 potential participants completed initial phone screen. 25 did not meet inclusion criteria based on age, neurological disorder status, recent hospitalization status, legal guardian status, or diagnosis. 48 participants were further screened. 10 of those participants did not meet inclusion criteria for diagnosis or substance use disorder status. 6 additional participants never initiated the intervention.
Arm/Group Title Intervention Group
Arm/Group Description All participants were assigned to this group and received the intervention.
Period Title: Overall Study
STARTED 31
COMPLETED 31
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Intervention Group
Arm/Group Description All participants were assigned to this group and received the intervention.
Overall Participants 31
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
46.097
Sex/Gender, Customized (Count of Participants)
Female
14
45.2%
Male
16
51.6%
Unknown
1
3.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
3.2%
Not Hispanic or Latino
30
96.8%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
9
29%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
5
16.1%
White
14
45.2%
More than one race
3
9.7%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
31
100%

Outcome Measures

1. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
Participants with schizophrenia or schizoaffective disorder
Arm/Group Title Intervention Group
Arm/Group Description All participants were assigned to this group and received the intervention.
Measure Participants 31
Mean (Standard Deviation) [score on a scale]
108.00
(7.13)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group
Comments Single arm
Type of Statistical Test Other
Comments Single group pre-post, follow-up
Statistical Test of Hypothesis p-Value 0.09
Comments
Method General Linear Model (repeated measures)
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.56
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group
Arm/Group Description All participants were assigned to this group and received the intervention.
Measure Participants 31
Mean (Standard Deviation) [score on a scale]
2.60
(1.36)
3. Secondary Outcome
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).

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Arm/Group 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. Motivation and Skills Support (MASS): Mobile phone-based application to support social skills and social motivation
Measure Participants 31
Mean (Standard Deviation) [score on a scale]
1.35
(0.64)

Adverse Events

Time Frame Adverse event data were collected over the full course of the study (total frame = 5 months).
Adverse Event Reporting Description Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title Intervention Group
Arm/Group Description All participants were assigned to this group and received the intervention.
All Cause Mortality
Intervention Group
Affected / at Risk (%) # Events
Total 0/31 (0%)
Serious Adverse Events
Intervention Group
Affected / at Risk (%) # Events
Total 0/31 (0%)
Other (Not Including Serious) Adverse Events
Intervention Group
Affected / at Risk (%) # Events
Total 0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Daniel Fulford
Organization Boston University
Phone (617) 358-6723
Email dfulford@bu.edu
Responsible Party:
Daniel Fulford, Assistant Professor, Occupational Therapy and Rehabiltiation Sciences, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT03404219
Other Study ID Numbers:
  • 1R21MH111501-01
First Posted:
Jan 19, 2018
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021