Understanding Social Situations (USS): Training to Improve Social Function in People With Psychosis
Phase: NA
Conditions: Psychosis
Sponsor: VA Office of Research and Development

Understanding Social Situations (USS): Training to 
improve social function in people with psychosis
NCT04557124
November 1, 2023

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PROJECT DESCRIPTION 
 
 
1. Principal Investigator:  Joanna Fiszdon, Ph.D. 
 
Project Title:  Understanding Social Situations (USS): Training to improve social function in people with 
psychosis 
 
2. Purpose:  We propose to evaluate the efficacy of Understanding Social Situations (USS), a behavioral 
training targeting social cognitive skills. The current proposal is to conduct a fully powered, rigorous 
randomized controlled trial to test the efficacy of USS versus an active control condition. One hundred twenty 
Veterans with psychotic spectrum disorders (PSD) will be randomized to 2 months of USS or an active control 
(AC) intervention matched for duration, therapist contact, and mode of delivery. Key social functioning 
outcomes will be measured using a multi-method approach of self-report, role-play, and experience sampling, 
conducted pre-intervention, post-intervention, and at 2 month follow-up, with an additional limited assessment 
at treatment mid-point.   
 
Primary Aim: 
Aim 1: Examine the efficacy of USS in improving social functioning. 
  H1.1: Compared to AC, USS will be associated with greater improvements on the Social Functioning Scale.  
 
Secondary Aims: 
Aim 2: Examine the efficacy of USS in changing real-world social behaviors. 
  H.2.1: Compared to AC, USS will be associated with greater improvements in real-world social behaviors, as  
  measured by ecological momentary assessment (EMA). 
Aim 3: Examine efficacy of USS in improving social interaction skills. 
  H.3.1: Compared to AC, USS will be associated with greater improvements on the UCSD Social Skills  
  Performance Assessment, a performance-based measure of social skills. 
Aim 4: Examine durability of USS effects on clinician and self-rated social functioning, real-world 
social behaviors, and social skills. 
  H 4.1 Above group differences will be maintained at 2-month follow-up. 
 
Exploratory Aims: Examine mechanisms of USS effects. 
  A. Target engagement and validation: examine impact of USS on a measure of USS content learning (USS  
       Skills Test) and relationship between content learning and improvement in social functioning. 
  B. Personalization: explore baseline cognitive, treatment dose, symptom clusters and demographic   
       variables as potential moderators of USS efficacy. 
 
Additional Aims: collect normative (psychiatric control) information about social function in non-psychotic 
psychiatric sample in order to better characterize the nature of social function and factors impacting social 
interactions in Veterans with versus without psychosis.  
 
3. Background:  
Functional disability is a core, defining feature of psychotic spectrum disorders (PSD), and persists even 
when psychotic symptoms are in remission4. A majority of people with schizophrenia are not competitively 
employed, have never been married, have some difficulty with self-care, and have poor community integration5-
8. Impairments in social function are also prominent, leading to significant social isolation and impeding 
recovery9. Social function deficits are present prior to illness onset10, persist throughout different phases of the 
illness11, and are more severe in PSD than in other serious mental illnesses12. Pharmacotherapy and other 
existing treatments fall short of significantly improving social and community functioning, and social re-

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over; not meeting criteria for substance use disorder in past 30 days; psychiatric stability as evidenced by 
minimum of 30 days since last psychiatric hospitalization and since last change in psychiatric medications; no 
evidence of developmental disability in chart or on baseline assessment; no severe, uncorrected 
auditory/visual impairment; no diagnosis of medical or neurological illness known to impair brain function 
including dementia, presence of seizures, history of head trauma with loss of consciousness > 1hr, or clear 
cognitive sequelae from other illness or injury, per medical chart review; fluency in English; ability to provide 
legal written informed consent (i.e. the participant does not have a conservator); not currently enrolled in 
another treatment study targeting, or expected to impact, functioning.  We hope to randomize approximately 
120 Veterans into the study conditions.  
Psychiatric control sample: Specific Inclusion/exclusion criteria for the psychiatric control group: age 18 and 
over; currently receiving mental health treatment; no lifetime diagnosis of psychotic disorder (e.g. 
schizophrenia, schizoaffective disorder, delusional disorder, psychosis NOS) based on clinical interview; not 
meeting criteria for PTSD in the past 30 days based on clinical interview; not meeting criteria for substance use 
disorder in past 30 days based on clinical interview; not meeting criteria for a major depressive or manic 
episode in the last 30 days based on clinical interview; psychiatric stability as evidenced by minimum of 30 
days since last psychiatric hospitalization, no current high risk for suicide flag on their chart, and no active 
suicidal or homicidal ideation in that past 30 days; no evidence of developmental disability in chart or on 
baseline assessment; no severe, uncorrected auditory/visual impairment; no diagnosis of medical or 
neurological illness known to impair brain function including dementia, presence of seizures, history of head 
trauma with loss of consciousness > 1hr, or clear cognitive sequelae from other illness or injury, per medical 
chart review; fluency in English; access to a smartphone to which they are willing to receive surveys via text 
message; ability to provide legal written informed consent (i.e. the participant does not have a conservator); 
We hope to have approximately 20 participants complete study procedures.  
 
Measures for primary psychotic-spectrum sample:  
Baseline assessments will consist of demographic, intelligence, psychiatric, cognitive, social function and 
knowledge of USS training content measures. Post-training and 2-month follow-up assessments will mirror 
baseline assessments, with the exception of diagnostic interviews and IQ estimate, which will only be 
administered at baseline.  An additional assessment of the primary outcome, SFS, and of the proposed 
mediator of treatment effects, USS Skills Test, will occur at treatment mid-point. Please refer to Assessment 
Timeline below. The baseline assessment will be split into a screening assessment to confirm study eligibility 
(demographics, WASI, SCID, SFS), and a subsequent baseline assessment for those who pass the screening 
(PANSS, PHQ-9, QLS, MCCB, SSPA, USS Skills Test) 
 
Intelligence: The Wechsler Abbreviated Scale of Intelligence (WASI68, 2-subtest estimate) will be used to 
obtain estimates of current intelligence (IQ Estimate score). The WASI 2-subtest IQ estimate correlates highly 
(r=.87) with the Wechsler Adult Intelligence Test 69, the most commonly used and accepted measure of 
intellectual function. It also has high internal consistency reliability (r=.93 for adult sample), and 2-12 week  
test-retest stability (r=.85). The WASI will be used to characterize the study sample and screen for intellectual 
disability (IQ < 70) at baseline.  
Diagnostic and Symptom: The Structured Clinical Interview for DSM-V (SCID70) will be used to confirm 
psychotic spectrum diagnoses. The SCID is the most commonly used semi-structured interview for obtaining 
DSM-V diagnoses. Modules A through E will be used to determine presence of psychotic and mood 
syndromes, substance use history, and differential diagnosis. The Positive and Negative Syndrome Scale 
(PANSS71) will be used to characterize participants by assessing the presence and severity of psychiatric 
symptoms. The PANSS is an interviewer-rated scale indexing the core symptoms of psychosis as well as a 
broad range of general psychiatric symptoms including depression and anxiety.  Each symptom is rated on a 
Likert-type scale ranging from 1-7, for total score range of 30 to 120. Initial reports using this scale provide 
evidence of good internal reliability for the three subscales (alpha =.73 to .83), with adequate test-retest 
reliability over 3-6 month inpatient phase (r=.60 to .80) and good interrater reliability (r=.83 to.87). Within our 
research group, ICC’s against gold standard, study PI, range from .85-.97 for PANSS components. For initial 
exploratory analyses of symptom severity as a potential moderator of treatment effects, PANSS Total Score 
will be used. As warranted, subsequent analyses may examine the Positive, Negative, and General symptom 

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subscales, as well as Depression and Anxiety scores. The Patient Health Questionnaire (PHQ-9) will also be 
used to assess depression. The PHQ-9 is a commonly used, 9-item, likert-style, self-report measure (Kroenke, 
Spitzer & Wiilliams, 2001). The Quality of Life Scale (QLS95) will be used to assess interviewer-rated 
functioning.  In addition to providing a total score, this well known measure of functioning can be subdivided 
into four separate domains; intrapsychic foundations, interpersonal relations, instrumental role functioning, and 
common objects and activities. 
  
Assessments  
Timeline 
 
  
  
  
  
  
Duration 
Measure type 
Pre Mid Post FU 
Demographics/Psychosocial 
 
10 min 
sample characteristics, potential 
moderators 
X 
 
 
 
Wechsler Abbreviated Scale 
of Intelligence (WASI, 2 
subtest) 
20 min 
IQ estimate, sample 
characteristics, potential 
moderator 
X 
 
 
 
Structured Clinical Interview 
for DSM (SCID) 
60 min 
diagnostic, sample 
characteristics 
X 
 
 
 
Quality of Life Scale (QLS) 
30 min 
social functioning, sample 
characteristics, potential 
moderator 
X 
 
X 
X 
Positive and Negative 
Syndrome Scale (PANSS) 
30 min 
symptom severity, sample 
characteristics, potential 
moderator 
X 
 
X 
X 
Patient Health 
Questionnaire-9 
2 min 
Depression symptoms 
X 
 
X 
X 
Matrics Consensus 
Cognitive Battery (MCCB) 
60 min 
cognition, sample 
characteristics, potential 
moderator 
X 
 
X 
X 
Social Functioning Scale 
(SFS) 
15 min 
social function primary 
outcome, potential moderator 
X 
X 
X 
X 
7-day EMA assessment 
3min/each 
assessment 
(total 12 min/day) 
social function secondary 
outcome 
X 
 
X 
X 
Social Skills Performance 
Assessment (SSPA) 
10 min 
social function secondary 
outcome 
X 
 
X 
X 
USS Skills Test 
5 min 
social cognition training target, 
potential moderator 
X 
 X 
X 
X 
 
Cognitive: Cognition will be assessed using the MATRICS Consensus Cognitive Battery (MCCB72). The MCCB 
was developed by an expert panel of researchers, under NIMH contract, as a broad yet sensitive measure to 
assess cognitive change in treatment studies. The MCCB includes assessment of 7 domains: speed of 
processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem 
solving, and social cognition. While an overall composite score is available, in recognition of diff erences 
between neurocognitive and social cognitive impairments, it is becoming more and more common in studies of 
neurocognitive function in psychosis to calculate a 6-domain composite score, omitting the social cognitive 
domain. This composite score will be used for initial exploratory analyses of cognition as a potential moderator 
of treatment effects. 
Social Functioning primary outcome: Social functioning will be measured using the interviewer-administered 
Social Functioning Scale (SFS73), which assesses social functioning across seven domains: social 
engagement/withdrawal, interpersonal behavior/communication, prosocial activities, recreation, 
independence—competence, independence—performance, and employment/occupation. The SFS is one of 
the best known measures of social functioning in schizophrenia, and was one of two social function measures 
nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess 
real-world outcomes74 based on its psychometric properties, sensitivity to change, relationship to symptoms, 

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and comprehensiveness. Importantly, our pilot data indicates that the SFS is sensitive to the effects of the  
USS intervention. Total score will be used as our primary outcome.  
 
Social Functioning secondary outcomes: Social Skills Performance Assessment (SSPA75) is a role-play 
measure of social skill ability. It consists of two, 3-minute, structured role plays (tenant meeting a new 
neighbor; tenant calling landlord to request repair). The role plays are audio-taped and rated on a number of 
characteristics including interest/disinterest, clarity, social appropriateness, negotiation ability, and overall 
conversation, among others. For our analyses, scores from the two role-plays will be summed into a single 
total score. Smartphone-delivered Ecological Momentary Assessment (EMA), an experience sampling method, 
will be used to capture information about the extent and type of social interactions, along with participants’ 
dispositions toward and subjective appraisals of these interactions. Questions were mostly adapted from 
earlier EMA work with similar populations76-79, and include prompts about the frequency and nature of social 
interactions, enjoyment level, perceived clarity of communication and confidence in understanding the other 
person’s intent, and anticipation of future social interactions. EMA methodology has the advantage of reducing 
memory demands and/or recall bias and providing an ecologically valid measure of day-to-day experiences.  
EMA has been successfully used to assess real-world interactions in Veterans with psychotic disorders, with 
reports of excellent adherence (85% of surveys), high test-retest reliability (r=.83), and modest correlations to 
in-lab self-report measures of functioning (E. Granholm, May 2019 personal communication, manuscript under 
review77). EMA questions will be administered via smartphone 4 times per day for a 7-day period at baseline, 
immediately after the end of the 2-month active phase, and at a follow-up two months following end of the 
active phase. Please refer to Appendix for additional details of EMA administration protocol, along with 
preliminary EMA questions.  
 
Training target: Consistent with the experimental therapeutics approach, we will not only evaluate outcomes of 
interest, but also the potential impact of the intervention on the hypothesized treatment mechanism. In this 
case, we hypothesize the mechanism to be social cognitive skill, indexed by learning of content taught during 
USS. Hence, we will use the USS Skills Test to index target engagement. The USS Skills Test is a 22-item 
measure assessing knowledge of principles and skills taught during the training54. Items on the USS Skills Test 
are similar to (though not identical) to those used in the USS training stimuli, and as such, should provide a 
proximal measure of training effects. Our pilot data indicates that the USS Skills Test is sensitive to training 
effects.   
 
Measures for normative psychiatric (non-psychotic) sample:  
Veterans in the psychiatric subgroup will be asked to complete a subset of measures administered to the 
psychosis sample and described above, specifically: background/demographic information, Social Functioning 
Scale (SFS), Patient Health Questionnaire-9 (PHQ-9), the Social Skills Performance Assessment (SSPA), and 
a baseline Ecological Momentary Assessment (EMA). Psychiatric diagnosis will be confirmed via psychiatric 
interview, using the Structured Clinical Interview (SCID) as needed. 
 
Interventions (only administered to psychotic-spectrum sample): 
 
Experimental intervention, Understanding Social Situations (USS):  

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USS was developed by the PI and collaborator Roberts under an NIMH R34 grant. It was developed to train 
higher-order social cognitive skills. Training content was largely adapted from successful lab-based 
experimental interventions targeting theory of mind and 
attributional bias. Given that significant cognitive 
impairments in people with psychosis can limit skill 
acquisition, USS was uniquely developed to lessen 
cognitive load by relying on delivery techniques that 
have previously been successfully used in cognitive 
remediation including scaffolding, hierarchical training, 
massed drill and practice, performance-based 
increases in task difficulty, and verbal mediation. 
Additional techniques include motivational 
enhancement and use of homework to promote 
bridging to real-world situations. Complex skills are 
trained by first practicing their individual components. 
There are four training modules (see below) that are 
administered over 8-10, individual, hour-long sessions. 
Training stimuli consist of photos, videos, cartoons, 
written vignettes, and audio clips of mostly social situations. Once participants complete the four USS modules, 
all training content will again be reviewed. This approach mirrors many real-world clinical setting where 
Veterans undergo multiple cycles of an intervention, is intended to further compensate for cognitive 
impairments, and is intended to assure that training content is learned and consolidated. In total, participants 
will be asked to undergo 16-20 USS sessions over 2 months.  
 
UNDERSTANDING SOCIAL SITUATIONS (USS) TRAINING 
Techniques employed throughout USS content include hierarchical training, massed drill and practice, 
breaking skills into subcomponents, graded increases in task difficulty, scaffolding, errorless learning, 
verbal mediation, modeling, minimizing memory load via visual cues, and use of homework to promote 
bridging to real-world situations. The first three USS modules contain hierarchical difficulty levels, with 
task difficulty manipulated by adjusting response format, plausibility of foils, stimulus ambiguity, 
valence, self-relevance, etc. Progress through the training is tailored to individual performance in order 
to provide an optimal level of challenge while minimizing frustration. Sessions are highly structured and 
include homework, review of prior session's content, modeling and practice of new skills, and 
assignment of new homework. 
Psychoeducation and motivation enhancement: The trainee is provided with a rationale for 
engaging in the ensuing training (to better understand social situations which will help in getting along 
well with others). Brief video vignettes of social problems are reviewed and the trainee’s own 
experiences with situations where s/he had difficulty figuring out what the other person was thinking or 
feeling are discussed. The trainee identifies a specific goal pertaining to his or her social life. An 
overview of the skills to be trained is provided.  
Module 1 Separating Facts from Guesses: Training focuses on distinguishing between observable 
behavior and inferences about thoughts, feelings and social meanings. Training progresses from 
identifying what are tangible facts, and distinguishing them from guesses, particularly about others' 
mental states. Training further progresses to distinguishing between good, fact-based guesses versus 
bad guesses that have little or no support. (Techniques adapted from Social Cognition Interaction 
Training, SCIT; Roberts & Penn55, 56). 
Module 2 Probability Judgments and Not Jumping to Conclusions: Training focuses on 
developing skills to evaluate the quality of guesses based on how much information is available to 
support guesses. Training progresses from rating guesses as good or bad, to rating the relative 
likelihood of multiple guesses about a single situation, to re-rating quality of different guesses as more 
information is provided about the situation (techniques adapted from Moritz & Woodward 57). 

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Module 3 Determining Others’ Mental States and Intentions: Training focuses on using verbal 
mediation to process temporal sequences of social events and identify information in support of 
various guesses about a character’s current or future intentions. Training progresses from evaluating 
individual stimuli to integrating information from multiple stimuli to making guesses about characters’ 
mental and emotional states and intentions (techniques adapted from Sarfati and colleagues 58, 59). 
Module 4. Inducing Positive Interpretive Bias: Cognitive bias modification training. Goal of this 
module is for trainees to develop an automatic bias toward interpreting ambiguous social events in a 
positive manner. Trainees practice by completing very brief written stories about themselves in social 
situations, with each story resolving in a favorable way. Unlike other modules, there are no difficulty 
levels (techniques adapted from Constans and colleagues60, 61). 
 
Matched Active Control intervention (AC):  
The active control (AC) intervention was selected to match USS on interaction with study staff, treatment 
duration and intensity, and delivery format. “Moving Forward: Overcoming Life’s Challenges” is a free, web -
delivered training developed by the VA as part of the Integrated Mental Health Strategy initiative to expand 
access, ensure quality of care, promote resilience and build better behavioral health systems. The training is 
based on Problem Solving Therapy80, an evidence-based cognitive-behavioral approach to developing problem 
solving skills to effectively cope with stressors81. It consists of 8 modules focused on what the training is, how it 
may be helpful, how to solve problems under stress, steps of problem solving, and how to apply what was 
learned to daily life. In preparation for the current grant submission, we thoroughly reviewed and timed module 
content, developed procedures for how this normally self -administered program can be delivered by a study 
trainer in 45-60 minute sessions, and created a training manual (see Appendix). Similarly to those in the USS 
condition, participants in AC condition will be asked to attend two cycles of the training, for a total of 
approximately 16-20 sessions over two months.   
 
Procedures for psychotic spectrum sample: Please refer to the study design and the assessments timeline 
(above) for detailed schematics of study procedures and assessments. Following written informed consent and 
baseline assessment, Veterans will be randomized (1:1) into one of two training conditions: Understanding 
Social Situations (USS) or a matched Active Control (AC). Training sessions will occur approximately twice per 
week for two months (16-20 sessions, given some expected variability in individual time to complete the 
training content). Training sessions will be video recorded for later fidelity ratings by research staff. 
Comprehensive assessments will be conducted at baseline and repeated at two months (end of active phase), 
and four months (two-month follow-up from end of active phase). An additional assessment for the primary 
outcome (SFS) and hypothesized moderator (USS Skills Test) will occur at one month (midpoint through the 
active phase). Participants will be oriented to the EMA procedures during the baseline assessment. This will 
include practice with receiving EMA survey links, navigating the questionnaires, and a comprehension check of 
survey questions and responses. Smartphones will be given to participants so that they can complete these 
EMA surveys.  In addition to the smartphones, a data plan will be provided for 6-months or until study 
completion.  Participants will then be provided with instructions for how to transfer the phone service into their 
name if they wish to keep the phone. For participants who are terminated for cause or decide to withdraw from 
the study, the dataplan will be terminated and the phone will be locked to prevent it being used to obtain a new 
wireless service plan. Orientation, including basic use and charging of the smartphone will be provided when 
the phones are given out. We anticipate that length of study participation for individual participants will be 
approximately 5 months.  
Procedures for normative psychiatric (non psychotic) sample: Following written informed consent and 
baseline screening assessment using measures described above (approximately 90 min session), participants 
who continue to meet all eligibility criteria will be oriented to the EMA procedures. This will include practice with 
receiving EMA survey links, navigating the questionnaires, and a comprehension check of survey questions 
and responses. Participants will be asked to save to their contacts the telephone number from which the 
surveys originate. Next, over the course of 7 days they will receive 4x/day brief surveys about their social 
interactions. Survey questions are the same as for the psychosis spectrum sample. Length of study 
participation for the normative sample is approximately 7 days (baseline screening assessment plus 7 days of 
EMA assessments). 

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COVID-19 Pandemic Procedures:  As long as COVID-19 remains a significant concern, this study will 
conduct the majority of research procedures remotely, via VA-approved telehealth platforms, for all participants 
recruited during the pandemic.  Conducting as many procedures remotely as possible will help to reduce the 
length of time that in-person interactions are taking place and thus increase staff and participant safety during 
this pandemic. 
Remote procedures:  In the setting of the novel coronavirus pandemic, the consent form will be mailed to 
subjects after participating in a phone screening to determine initial eligibility.  Upon receipt of the consent 
form, the consent form will be reviewed with the subject during a telehealth visit, signed and returned to the 
research team when the participant comes in for their in-person visit.  The majority of the study assessments 
will be conducted using VA-approved video conference platform. Appointments conducted via video will not be 
recorded, with the exception of the USS/active control sessions, which are also recorded during in-person 
sessions, to allow for fidelity ratings to be conducted later.   
Any virtual sessions will follow safety guidelines that are used in routine VA telehealth care, including the 
following: 
1. Communicating to the participant the importance of having private space to ensure their 
confidentiality during study sessions 
2. Determining an emergency contact, and the location/address of participant at the time of the study 
session 
3. Using available elements of the video platform to ensure confidentiality (e.g., “locking” the virtual 
meeting room) 
 
When administering assessments that measure depression or SI (PANSS, PHQ-9, or SCID) remotely, in 
addition to the safety precautions above, we will ensure that the PI is readily available.  If the subject 
expresses SI, whoever is doing the assessment will contact the PI who will do a more detailed imminent risk 
assessment over the phone.  If the PI believes there is risk and is concerned for the study participant’s safety, 
911 will be called for a welfare check. 
 
In order to allow for remote administration and to limit in-person visits, some changes to the MCCB cognitive  
assessments have been made including: 
• 
Eliminating spatial span, BVMT and mazes subtests 
• 
Replacing the MCCB Symbol Coding with an oral version of the Symbol Digit Modalities Test,  
• 
Using the oral version of Trails A and B instead of the standard version of the Trails A 
 
In-person study visits conducted at baseline, post-training and follow-up time points will kept as brief as 
possible, and include the following safety guidelines: 
• 
For any in-person visits that take place, one day prior to the visit and/or at time of visit, participants will 
be asked the standard COVID-10 screening questions in place at VACHS, and  be asked to use a hand 
sanitizer upon entering the office.  
• 
Participants will be required to wear a 2-ply face mask when in the room with research staff, and if they 
do not have one, one will be provided for them. 
• 
Staff will utilize masks, gloves, face shields and social distancing during study visits, and will sanitize 
the office between each in-person visit and at the end of the day. 
 
 
Recruitment: Veterans with and without psychotic spectrum diagnoses will be recruited from VACHS outpatient 
clinics via flyers, presentations of study to treatment teams, other research groups, and MH clinicians. The 
study will also be presented to Veterans during community meetings of the VACHS Psychosocial 
Rehabilitation and Recovery Center, which serves Veterans with serious mental illness. Recruitment will also 

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occur through our re-contact repository (those who have participated in our group’s prior studies and agreed to 
be re-contacted with information about additional research opportunities), with the exception of those who 
participated in the initial USS treatment development trial. We may also pull MH clinic appointment lists, screen 
upcoming appointments for potential eligibility, alert providers to upcoming appointments with potentially 
eligible participants, and ask that they refer those who are interested in learning more about the study.  We will 
also offer a small incentive to past/current participants who refer other eligible Veterans. For Veterans with 
psychotic spectrum diagnoses only, we may also send out study solicitation letters (with opt-out cards), as has 
previously been approved by the HSS. 
 
Randomization for psychotic spectrum sample: Veterans who meet eligibility criteria and consent to study 
participation will be randomized to receive either USS or AC in a 1:1 ratio. Randomization will be stratified by 
baseline SFS score, using a permuted block design with variable block size. The randomization scheme will be 
computer-generated by the statistician and the allocation sequence will be concealed.   
Payment for psychotic spectrum sample: $50/each for baseline ($25 for initial screening plus $25 for 
subsequent baseline assessment), post-training and 2-month follow-up assessments; $10 midpoint 
assessment; $1/each EMA survey assessment ($4/day); $10/training session.  Smartphones will be provided 
to all participants with 6-month data plans and the option to keep the phone at the conclusion of the study and 
transfer service into their name.  
Payment for normative psychiatric control sample: $25 for baseline screening assessment; $1/each EMA 
survey assessment done within 1 hour of survey receipt ($4/day over 7 days, for $28 EMA maximum). Total 
study participation payment up to $53.  
 
Fidelity: In the full study, we will promote equipoise between the USS and AC conditions by describing the 
project to potential participants as evaluating the efficacy of two different trainings in improving quality of life. 
The success of this will be assessed at end of study participation, when participants will be asked to indicate 
whether they thought they received the experimental or control condition (dichotomous ratings) . As detailed 
below, we are using an active intervention (with different treatment targets) for the control condition, hence 
expect that most participants will indicate they received an active, potentially efficacious treatment. 
 
Data integrity and management: Data integrity is a process that begins with appropriate administration, 
scoring, and recording of results. All study staff will be trained on any new procedures. Data flow will be 
reviewed during weekly lab meetings. We will use VA RedCAP (Research Electronic Data Capture) for data 
collection and management for all but the EMA assessments. VA RedCAP is a web-based application, 
accessible only on VA network, and housed on the VA Informatics and Computing Infrastructure (VINCI)  
server. It was specifically designed for human subjects research, and includes multiple features to enhance 
data quality control, ease data entry, and assure data security. Because VA RedCAP survey links can only be 
accessed on VA intranet, to which study participants do not have access, we will use our Qualtrics to capture 
EMA data. Procedures for using Qualtrics for EMA data are in place, and have previously been approved by 
the VACHS IRB, Information Security Officer and Privacy Officer.   
 
Statistical Analysis Plan: 

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Justification of Sample Size: The primary hypothesis is that 
USS will result in greater total SFS scores immediately 
following training (i.e. ‘post’ assessment) compared to control. 
We have powered our study to detect what we consider a 
clinically meaningful, moderate effect on this measure. Given 
the following: 1) power of 90%, 2) a two-sided 0.05 
significance level, 3) a standard deviation for total SFS score 
of 13.1 (from our preliminary data), and 4) a 1:1 intervention 
allocation, a sample size of 46 subjects per group will be 
required to detect a 9 point difference (i.e. moderate effect 
size d=0.69) between USS and control in total SFS score at 
the post assessment. Please refer to Figure, showing the 
power to detect different effect sizes in total SFS given this 
sample size. A total of 120 participants will be enrolled and 
randomized to accommodate up to 20% dropout.  
While inherently difficult to define as it varies by perspective 
(e.g. researcher, consumer, insurance company)82, we settled 
on moderate ES on SFS as clinically meaningful based on past social cognitive studies that used the SFS and 
noted that improvement in social relationships (more friends, less time spent alone, higher quality of social 
communication) were observed with small-medium effect sizes83. Small-medium effects on the SFS have also 
been related to greater social acceptability by peers, better overall social skills ability, and higher medication 
compliance, with effects greater than 0.50 on social cognitive measures distinguishing between patients with 
psychosis and higher functioning patients with bipolar disorder84. Perhaps the most striking example of the 
real-world significance of change on the SFS comes from the original SFS validation study, wherein 11 point 
difference separated those who were employed from those who were not 73.  
 
General Approach: Nominal and ordinal categorical variables will be summarized using frequencies and 
percentages. Continuous variables will be summarized with the following descriptive statistics: N, mean, 
standard deviation, median, minimum, maximum, interquartile range, and range. No imputation of missing data 
will be performed in the primary and secondary analyses. Diagnostic tests and sensitivity analyses will be 
performed. Parametric distributional assumptions will be checked. If assumptions fail, other distributions will be 
considered prior to transformations and non-parametric methods. For all analyses, two-sided significance tests 
will be implemented and will be performed using SAS v9.4 (Cary, NC). 
Comparability of Baseline Characteristics: Distributions of baseline demographic and clinical 
characteristics will be summarized. Comparability for continuous variables will be examined graphically and by 
summary statistics (means, medians, quartiles, etc.).  Categorical variables will be examined by frequency 
distributions. 
Analysis of Primary Outcome SFS (Aim 1): The primary objective of the analysis is to demonstrate that 
USS will improve social functioning at the end of training more than active control in participants with PSD and 
impaired social functioning. The primary outcome (total scores on the SFS) will be assessed prior to initiation 
of intervention (pre), the training mid-point (mid), the end of training (post) and 2 months following the end of 
training (FU). Likelihood-based ignorable analysis using a linear mixed model will be used to compare social 
functioning between groups85, 86. The primary advantage of the repeated measures linear mixed model when 
compared to commonly used methods such as complete case analysis and single imputation (e.g. last 
observation carried forward) is its flexibility in handling missing data. This analysis will assume that missing 
data occurs at random (i.e. MAR, not informative). The inclusion of pre, mid and FU outcome data in the model 
will assist in meeting this assumption. Furthermore, we will evaluate patterns of missing data as well as 
determine baseline characteristics that are predictive of dropout. If identified, these characteristics will be 
included in the model to meet the MAR assumption. The mixed model will include fixed effects for intervention 
(USS vs. active control), time (mid, post, FU), and the interaction of intervention with time. An additional fixed 
effect will be included for baseline SFS at pre. An unstructured covariance pattern will be used to 
accommodate correlation from repeated measures. A linear contrast will be used to estimate intervention 
group differences and 95% confidence intervals at the post assessment. 

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Analysis of Real World Social Behaviors (Aim 2): Ecological momentary assessment (EMA) analyses 
will be conducted using a multilevel modeling approach87.  Analyses handle data estimation with a restricted 
maximum likelihood approach.  Data will be organized hierarchically, with within-person/random EMA prompts 
across the study period nested within people.  Random (within-person) coefficients will be estimated for each 
person at Level 1, while fixed (between-person) coefficients will be estimated at Level 2.  Within-person 
variables will be centered at Level-1 and between-person variables will be grand mean centered at Level-2 88-
90. We will examine associations between [e.g., attributions] and [e.g., number of interactions] at Level 1, and fit 
models with fixed [e.g. group, age, gender] main effects at Level 2.  We will also examine [L1] and [L2] cross-
level interactions. 
Analysis of Social Interaction Skills (Aim 3) and Durability (Aim 4): The secondary outcome social 
interaction skills, assessed by SSPA, will be compared between USS and control using a repeated measures 
linear mixed model similar to that described in the analysis of the primary outcome. Durability will also be 
compared between USS and control using the mixed model. For primary and secondary outcomes, linear 
contrasts will be used to estimate intervention group differences and 95% confidence intervals at the 2 -month 
FU assessment. 
Analysis of Mediation (Exploratory Aim A): We will explore content learning (USS Skills Test) as a 
potential mediator of the relation between intervention and changes in social functioning. Direct and indirect 
effects will be estimated using a structural equation model. Mediation (i.e. indirect effects) will be tested using 
the bootstrapping approach91. 
Analysis of Moderation (Exploratory Aim B): Heterogeneity of treatment effects (HTE) for the primary 
outcomes will be explored in subgroups of participants based on baseline characteristics including cognition, 
symptom clusters, illness characteristics, medication dose (chlorpromazine equivalents) and demographic 
variables. These subgroup analyses are aimed at determining whether there is differential effectiveness of the 
interventions among participant subgroups. Evidence of HTE will be based on tests of interaction within the 
longitudinal model structure described above.  
Interim Monitoring: Interim monitoring will focus on safety, recruitment, adherence to protocol, baseline 
comparability of intervention groups, completeness of data retrieval, and uptake of the assigned intervention. A 
set of monitoring tables will be generated for this purpose. No interim monitoring for efficacy or futility is being 
proposed. 
 
Analysis of social function between the psychotic spectrum and normative psychiatric sample: 
Multilevel modeling will be used to examine the predictive ability of social rewards on later social motivation 
and compared between the psychosis spectrum and normative samples. To examine the frequency of negative 
appraisals of social interactions and their predictive ability, and to compare this information between psychotic 
and normative samples, two models will test the effect of group (PSD/control) on social rewards (model 1) and 
negative social appraisals (model 2). Additional multi-level models will examine desire for socialization and 
initiation of future social activity. In each model, group, social reward, and the group-by-social-reward 
interaction will be included as predictor variables. Similar models predicting desire for socialization and 
initiation of future social activity will be computed with group, negative social appraisal, and their interaction as 
the predictor variables.  
 
Plan for Missing Data: Several strategies will be imposed to accommodate the likelihood that missing 
data will occur during this study. Prevention is the most obvious and effective manner to control bias and loss 
of power from missing data92. Prior to the trial we will pilot data collection procedures. Variables with large 
proportions of missing data will be excluded from collection. We will follow the intent to treat principle, requiring 
follow-up of all participants randomized regardless of the treatment received 93. Regular data entry into case 
report forms (CRFs) combined with monitoring and missing data reports will trigger protocols for tracking and 
obtaining missing data. Despite these prevention efforts it is reasonable to assume missing data will occur. Our 
proposed primary and secondary analyses make use of all available data and are valid under the assumption 
that missing data will be missing at random (MAR)86, 94. We will evaluate the plausibility of this assumption by 
determining the extent of missing data and use logistic regression to identify factors associated with missing 
data. We will conduct sensitivity analysis using a pattern-mixture approach implemented using multiple 

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imputation under missing not at random (MNAR) assumptions to examine the robustness of conclusions of the 
primary analysis to missing data86, 92. 
 
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