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| Name | Class |
|---|---|
| San Francisco State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivation and Skills Support (MASS) | Behavioral | Mobile phone-based application to support social skills and social motivation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Fulford, PhD | CRC BU Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco State University | San Francisco | California | 94132 | United States | ||
| Boston University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34128812 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | All participants were assigned to this group and received the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | All participants were assigned to this group and received the intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants with schizophrenia or schizoaffective disorder | Posted | Mean | Standard Deviation | score on a scale | Baseline (study entry) and follow-up (3 months post-intervention) |
Adverse event data were collected over the full course of the study (total frame = 5 months).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | All participants were assigned to this group and received the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Fulford | Boston University | (617) 358-6723 | dfulford@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 | May 11, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2019 | May 11, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| 2 times per day for 2 months (intervention period). |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Intervention Group | All participants were assigned to this group and received the intervention. |
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| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline (study entry) and follow-up (3 months post-intervention) |
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| Secondary | 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:
| Posted | Mean | Standard Deviation | score on a scale | 2 times per day for 2 months (intervention period). |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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