Schizoaffective Disorder, Schizophrenia
Conditions
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.
Interventions
BEHAVIORALMotivation and Skills Support (MASS)
Mobile phone-based application to support social skills and social motivation
Sponsors
San Francisco State University
Boston University Charles River Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. How well do you think you communicated in those conversations? (from 1 \[I did not communicate well at all\] to 4 \[I communicated very well\]) 2. To what extent were those interactions worth the effort? (from 1 \[not worth the effort at all\] to 4 \[definitely worth the effort\]) 3. 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group All participants were assigned to this group and received the intervention. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Continuous | 46.097 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 31 participants |
| Sex/Gender, Customized Gender Female | 14 Participants |
| Sex/Gender, Customized Gender Male | 16 Participants |
| Sex/Gender, Customized Gender Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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).
Time frame: Baseline (study entry) and follow-up (3 months post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale. | 2.60 score on a scale | Standard Deviation 1.36 |
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).
Time frame: Baseline (study entry) and follow-up (3 months post-intervention)
Population: Participants with schizophrenia or schizoaffective disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Changes in Social Functioning as Measured by the Social Functioning Scale (SFS) | 108.00 score on a scale | Standard Deviation 7.13 |
Comparison: Single armp-value: 0.09General Linear Model (repeated measures)
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: 1. How well do you think you communicated in those conversations? (from 1 \[I did not communicate well at all\] to 4 \[I communicated very well\]) 2. To what extent were those interactions worth the effort? (from 1 \[not worth the effort at all\] to 4 \[definitely worth the effort\]) 3. 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Changes in Experience-Sampling-Based Self-Reports of Social Appraisals | 1.35 score on a scale | Standard Deviation 0.64 |