Horyzons: Implementation in Clinical Practice
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Sponsor: University of North Carolina, Chapel Hill

 
Horyzons:  
Implementation in Clinical Practice 
 
 
 
NCT number NCT04673851 
Document Date 10/26/2022 
 

Clinical Protocol & Data Analytic Plan 
 
Horyzons:  
Implementation in Clinical Practice 
 
NCT04673851 
Version 2.0 
Protocol Date:  October 26, 2022 
 
 
 
David L. Penn, PhD 
Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) 
250 Davie Hall 
Chapel Hill, NC, 27599 
Phone (919) 843-7514 
dpenn@email.unc.edu 
Diana Perkins, MD, MPH 
Co-Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) – School of Medicine 
200 N Greensboro St, Suite C-6 
Carrboro, NC 27510 
Phone (919) 360-1602 
Diana_perkins@med.unc.edu 
 
 
 
 
 
 
 
 
This study is sponsored by the North Carolina Department of Health and Human Services 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................................... 2 
ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................................................................... 3 
PROTOCOL SYNOPSIS .............................................................................................................................. 4 
1 BACKGROUND AND RATIONALE ........................................................................................................... 8 
2 RESEARCH DESIGN AND METHODS ...................................................................................................... 9 
2.1 OVERVIEW ...................................................................................................................................... 9 
2.2 SUBJECTS ...................................................................................................................................... 11 
2.2.1 INCLUSION CRITERIA ............................................................................................................. 12 
2.2.2 EXCLUSION CRITERIA ............................................................................................................. 12 
3 ASSESSMENT OF DATA ....................................................................................................................... 12 
3.1 OUTCOMES .................................................................................................................................. 12 
4 STUDY DESIGN .................................................................................................................................... 12 
4.1 SCREENING/BASELINE PROCEDURES ........................................................................................... 12 
4.1.1 SCREENING PROCEDURES ..................................................................................................... 13 
4.1.2 BASELINE PROCEDURES ........................................................................................................ 13 
4.2 INTERVENTION PERIOD PROCEDURES ......................................................................................... 13 
4.2.1 MID-TREATMENT PROCEDURES............................................................................................ 13 
4.2.2 POST-TREATMENT PROCEDURES .......................................................................................... 14 
4.2.3 ADDITIONAL ASSESSMENT PROCEDURES.............................................................................14 
4.3 FOCUS GROUPS............................................................................................................................14 
5 DATA ANALYTIC PLAN ......................................................................................................................... 15 
5.1 PRIMARY OUTCOME MEASURES .................................................................................................. 15 
5.2  SECONDARY OUTCOME MEASURES ............................................................................................ 15 
5.3 TERTIARY/EXPLORATORY OUTCOME MEASURES……………………………………………………………….......16 
5.4  POWER ANALYSIS ........................................................................................................................ 21 
5.5 DATA MONITORING.....................................................................................................................21 
6 RISKS AND BENEFITS ........................................................................................................................... 22 
6.1 MONITORING RISKS ..................................................................................................................... 22 
6.2 NON-SIGNIFICANT RISK DOCUMENTATION ................................................................................. 24 
6.3 POTENTIAL BENEFITS OF RESEARCH TO SUBJECTS AND OTHERS ................................................. 24 
6.4 CONFIDENTIALITY OF DATA .......................................................................................................... 25 
7  SAFETY MANAGEMENT...................................................................................................................... 26 
7.1 ADVERSE EVENTS ......................................................................................................................... 26 
7.2 SERIOUS ADVERSE EVENTS ........................................................................................................... 26 
7.3 DEATH .......................................................................................................................................... 27 
8 RECRUITMENT STRATEGY ................................................................................................................... 27 
9 CONSENT PROCESS ............................................................................................................................. 27 
10 REFERENCES...................................................................................................................................... 29 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
CBT 
Cognitive-Behavioral Therapy 
CSC 
Coordinated Specialty Care 
DUP 
Duration of Untreated Psychosis 
FEP 
First Episode Psychosis 
LAR 
Legally Authorized Representative 
MOS 
Medical Outcomes Study 
NC 
North Carolina 
NIMH 
National Institutes of Mental Health 
NSR 
Non-significant Risk 
OASIS 
Outreach and Support Intervention Services 
PI 
Primary Investigator 
PSS 
Peer Support Specialist 
PWS 
Psychological Wellbeing Survey 
SIAS 
Social Interaction Anxiety Scale 
SSD 
Schizophrenia Spectrum Disorder 
UCLA 
University of California, Los Angeles 
WAI-I 
Working Alliance Inventory – guided Internet interventions 
 
 
 

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PROTOCOL SYNOPSIS 
Study Title 
Horyzons: Implementation in Clinical Practice 
Funder 
North Carolina Department of Health and Human Services, 
University of North Carolina at Chapel Hill 
Clinical Phase 
Phase I 
Study Rationale 
The purpose of the present study is to investigate the feasibility 
and acceptability of implementing a moderated online social media 
platform with therapeutic content, Horyzons, as a part of care 
received at first-episode psychosis (FEP) clinics across North 
Carolina. 
Study Objective(s) 
Examine the feasibility and acceptability of implementing Horyzons 
at NC FEP clinics through the following objectives: 
1. Assess change in psychological measures across the three-
month (cohort 1) and six-month (cohort 2) study period 
(primary) 
2. Ability to meet our recruitment targets 
3. Evaluation of the safety and privacy protocol 
4. Evaluate frequency and types of engagement on Horyzons 
5. Identify barriers/facilitators to implementing Horyzons 
Test Article(s) 
(If Applicable) 
Horyzons is a private digital platform that includes curated 
therapeutic content surrounding issues such as generalized anxiety, 
social anxiety, social functioning, depression, and distress 
tolerance. The site also includes a social media function, in which 
participants and peer support specialists (PSS) can post text, 
images, and videos. The site is moderated by graduate students 
and trained clinicians. 
Study Design 
 
This is an open trial enrolling both clients from NC FEP clinics. FEP 
clients will participate in the experimental arm of the trial (access 
to Horyzons), and FEP clinicians will not.  We will also ask clients 
and clinicians to complete qualitative feedback about Horyzons. 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. Clients must be between the ages of 16 and 35 
2. Clients must have a diagnosis of schizophrenia, 
schizoaffective disorder, schizophreniform disorder, or 
Unspecified Schizophrenia Spectrum or Other Psychotic 
disorder 

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3. Clients must be receiving services at one of the four FEP 
clinics in North Carolina (OASIS, Encompass, Eagle, or 
SHORE) or one of the three UNC STEP-affiliated clinics (Carr 
Mill Mall, Vilcom Center, Main Wake Clinic) 
4. Clients must not have had thoughts of harming themselves 
in the month before enrollment 
5. Clients must not have been hospitalized for psychiatric 
reasons in the three months before enrollment 
6. Clients must not have had a psychiatric medication change 
in the month before enrollment 
7. Clients must have access to the internet through a phone, 
tablet, or computer 
Exclusion Criteria 
1. Clients who do not speak English will not be considered for 
enrollment 
2. Adult clients (18+ years old)  with legal guardians (LARs) will 
not be considered for the study 
Number Of Subjects  
Cohort 1: 25 client participants with SSDs, 12 clinician participants 
from NC FEP clinics; Cohort 2: 37 client participants with SSDs, 11 
clinician participants from NC FEP clinics. 
Study Duration 
For Cohort 1, each subject’s participation will last 3 months from 
baseline to post-treatment; the entire study for this group is 
expected to last approximately 3-4 months. For Cohort 2, each 
subject’s participation will last 6 months from baseline to post-
treatment; the entire study for this group is expected to last 
approximately 6-7 months. 
Study Phases 
Screening 
Study Treatment 
Focus Groups 
Screening- Completed prior to the first virtual appointment via a 
telephone screen to confirm study eligibility. 
Baseline- Participants in both cohorts who are deemed eligible 
schedule a virtual appointment with the study coordinator to 
obtain consent, HIPAA authorization, and complete the baseline 
assessments (Demographics, UCLA Loneliness Scale, MOS Social 
Support Survey, SIAS, short-form PWS). Client participants are 
then oriented to the Horyzons site. Participants in the second 
cohort only also complete other assessments (Questionnaire 
about the Process of Recovery, Social Anxiety Scale for Social 
Media Users, Modified Colorado Symptom Index, and Twente 
Engagement with eHealth Technologies Scale). 
Study Treatment- Client participants will be given access to the 
digital platform Horyzons for three months. Weekly engagement is 
decided by the participant. Digital access is available daily, digital 

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access to PSS and online therapists is made available daily, and 
virtual “Horyzons Hangs” are hosted over Zoom by PSS biweekly. 
Mid-treatment- Participants in both cohorts will complete 
assessments (UCLA Loneliness Scale, MOS Social Support Survey, 
SIAS, short-form PWS, WAI-I, and Perceived Autonomy Support 
Scale). Participants in the second cohort only also complete other 
assessments (Questionnaire about the Process of Recovery, Social 
Anxiety Scale for Social Media Users, Modified Colorado Symptom 
Index, and Twente Engagement with eHealth Technologies Scale). 
Post-treatment – Participants in both cohorts will complete 
assessments (UCLA Loneliness Scale, MOS Social Support Survey, 
SIAS, short-form PWS, WAI-I, and Perceived Autonomy Support 
Scale). Participants in the second cohort only also complete other 
assessments (Questionnaire about the Process of Recovery, Social 
Anxiety Scale for Social Media Users, Modified Colorado Symptom 
Index, and Twente Engagement with eHealth Technologies Scale). 
An additional feedback survey and qualitative interview are 
completed. 
Additional assessment timepoints for the second cohort: 
Participants in the second cohort will complete the following 
assessments at 1.5 months and 4.5 months following baseline 
(WAI-I, Perceived Autonomy Support Scale, Twente Engagement 
with eHealth Technologies Scale). 
Focus Groups- Participating clinicians and PSS take part in small 
focus groups to discuss feasibility, acceptability, and 
implementation of Horyzons at their NC FEP clinics. 
Efficacy Evaluations 
Primary outcomes (both cohorts) - The UCLA Loneliness Scale and 
MOS Social Support Survey (total score) will be used to assess 
subjective feelings of loneliness and social support. 
Secondary outcomes (both cohorts) - The SIAS and short-form PWS 
will be used to assess subjective feelings of social anxiety and 
psychological wellbeing. 
Tertiary/Exploratory Outcomes (both cohorts) - Quantitative and 
qualitative feedback collected at post-treatment and in focus 
groups will be used to explore feasibility and acceptability of 
Horyzons as a support tool in NC FEP clinics. Subscales from the 
MOS Social Support Survey and the short-form PWS as well as total 
scores from the WAI-I and Perceived Autonomy Support Scale may 
be explored in data analysis. Among the second cohort only, other 
scales/subscales such as the Questionnaire about the Process of 
Recovery, Social Anxiety Scale for Social Media Users, Modified 

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Colorado Symptom Index, and Twente Engagement with eHealth 
Technologies Scale may be explored in data analysis.  
Safety Evaluations 
A safety plan for Horyzons was developed before participants 
joined the Horyzons digital platform by PI Dr. David Penn and study 
coordinator Elena Pokowitz. All safety measures were approved by 
the director of each NC FEP clinic. 
Statistical And Analytic 
Plan 
Analyses will primarily be descriptive in nature. We will calculate 
means, standard deviations, and effect sizes of the primary 
outcomes (loneliness, social support) and secondary outcomes 
(social anxiety, psychological wellbeing).  
DATA AND SAFETY 
MONITORING PLAN 
Privacy and online safety will be managed in accordance with the 
'Online social networking' guidelines published by 'Cybersmart', a 
national cybersafety and cybersecurity education program 
managed by the Australian Communications and Media Authority 
(ACMA). Online safety will be monitored by Horyzons moderators 
(clinicians involved in the project, peer support specialists, 
graduate students in the Department of Psychology and 
Neuroscience) with supervision from the Principal Investigator. Dr. 
Perkins will function as the Project Medical Officer.  
 
 
 

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1 BACKGROUND AND RATIONALE 
Schizophrenia is one of the most devastating and costly of the medical/psychiatric disorders. In the last 25 
years, first episode psychosis (FEP) services have emerged to thwart the high relapse rates associated with this 
disorder and increase client treatment engagement. Increasing evidence shows that such services lead to 
improvements in symptoms, social functioning, quality of life and treatment satisfaction (1). In the United 
States, these services have come to be known as Coordinated Specialty Care (CSC).  
 
There are a number of North Carolina based CSC programs that provide early psychosis treatment to 
adolescents and young adults who have recently experienced the onset of psychosis.  Specifically, there are 4 
CSC programs in operation in North Carolina, including the Outreach and Support Intervention Services 
(OASIS) clinic in Chapel Hill, the Eagle Program for First Episode Psychosis in Charlotte, the Wake Encompass 
Program in Raleigh, as well as the SHORE program in Wilmington. Each CSC clinic employs a multidisciplinary 
team of providers that promotes recovery, person-centered and culturally competent evidence-based 
interventions with the goal of decreasing illness severity and reducing or preventing disability by intervening 
early in the course of illness. The goal of these programs is to help individuals get back “on track” in order to 
achieve school, work, relationship and other life goals. Evidence-based services including CBT-based individual 
psychotherapy, evidence-based pharmacology, supports for wellness and primary health coordination, family 
education and support, case management, supported employment and education, and/or peer support with 
an emphasis on shared decision-making, values, and recovery. 
 
Young people receiving services from CSC programs typically attain significant positive outcomes including 
decreased rates of hospitalization and improved social and occupational functioning within an average of two 
years of treatment (2). However, treatment benefits are usually not maintained over time (3-4) in particular 
when clients are less engaged in treatment or have recently experienced discharge from the program. For 
instance, the benefits of early intervention seen at the end of 2 years may not persist at 5 years (5). There is a 
need, therefore, to explore ways to provide ongoing support for individuals experiencing first episode 
psychosis. This support should address specially what some have called "social network crisis" experienced by 
the FEP population. This refers to the limited social networks and community support that individuals with 
psychosis generally have. Innovative approaches through internet-based interventions may shed valuable light 
on the issue of maintaining treatment effects derived from FEP services, and offer additional social support to 
those enrolled in such services. 
 
Additionally, the proposed research is aligned with the NIMH strategic objective of striving for prevention and 
cures through the study of mechanisms of therapeutic action. Specifically, it aligns with the goals of 
developing new treatments based on discoveries in the behavioral sciences and testing interventions for 
effectiveness in community practice settings. This project in essence builds and extends the findings of 
research on the effectiveness of CSC and looks to determine whether these benefits can be extended beyond 
CSC in a web-based platform delivered to individuals in the community.  
 
We suggest that internet-based interventions have the potential to provide cost-effective, non-stigmatizing, 
constantly available support to FEP people. These interventions, especially those aimed to strengthen social 
networks, can be used to counteract social isolation and disadvantage; increase functional outcomes and 
engagements (6); reduce symptomatology; and improve uptake and acquisition of therapeutic strategies. 

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These also provide an entirely new approach in which participants can safely self-disclosure, take positive 
interpersonal risks, gain perspective, broaden and rehearse coping skills, obtain encouragement and 
validation, and learn how to solve problems (7). 
 
The purpose of this study is to examine the feasibility and acceptability of implementing Horyzons across two 
cohorts of clients receiving routine care at clinics across North Carolina that provide services to individuals 
experiencing schizophrenia spectrum and other unspecified psychotic disorders, including those in their first 
episode of psychosis (FEP). Horyzons is an online platform that integrates: i) peer-to-peer on-line social 
networking; ii) individually tailored interactive psychosocial interventions; and (iii) trained moderation. First 
tested in Australia, this type of intervention has not been evaluated as part of standard service provision to 
individuals with psychosis in the US.  
 
Of note, the pilot study that was completed at the Outreach and Support Intervention Services (OASIS) clinic 
incorporated Horyzons as an adjunct to care rather than part of routine services. Also, there will be no 
incentives provided for engagement in Horyzons during the proposed implementation as our goal is to see 
examine the process by which clients are referred and maintained in the program.  As such, we seek to 
evaluate the extent to which Horyzons can be integrated into typical treatment at four FEP clinics across North 
Carolina. 
 
2 RESEARCH DESIGN AND METHODS 
2.1 OVERVIEW  
Participants (clients) will be given access to Horyzons (which is considered a “non significant risk” 
medical device and is described below) from their date of enrollment up to 3 months in the first cohort 
(enrolling January 2021) and up to 6 months in the second cohort (enrolling February 2022). Horyzons will 
be monitored daily (two hours per weekday & one hour per weekend day) by trained peer support 
specialists, master's level clinicians, Dr. David Penn (PI), and/or graduate students in the Department of 
Psychology and Neuroscience at UNC.  In an effort to facilitate and monitor engagement, a protocol is in 
place that directs moderators to contact participants via text message and/or email if an he/she/they have 
not logged onto the platform for two weeks, and via telephone if a participant remains inactive for an 
additional two weeks. The principal investigator, David Penn, will lead weekly supervision calls to ensure 
appropriate care and support of clients involved in this project, to discuss case conceptualization and 
suggestions for engaging clients in the platform, as well as to monitor any potential safety concerns. 
 
Overview of Horyzons. Horyzons is an online social media platform that integrates: i) peer-to-peer 
on-line social networking; ii) individually tailored interactive psychosocial interventions; and (iii) expert 
moderation. 
 
Peer-to-peer online social networking (the “Community”). The ‘community’ page includes a web feed 
where clients and moderators can post comments, information, upload pictures and videos, and ‘like’ 
different content. Moreover, the system includes a ‘wall’ function displaying the activity of individual 
users, and a ‘network’ (similar to a ‘friends’ function). The open trial also incorporates the participation of 
peer support specialists. Peer supports are individuals with lived experience of severe mental illness who 
are familiar with the Horyzons platform and affiliated with one of the first episode clinics in North Carolina 

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at which this study will be implemented.  These individuals are part of the investigational staff who will be 
interacting with participants for research purposes, and will also provide feedback (via focus groups with 
clinicians) upon completion of the study. Their primary function will be to induct clients to the platform, 
reach out to inactive participants, answer any questions clients may have about the site, and help facilitate 
discussion in the cafe and other sharing areas of the platform. Research staff at the university and/or 
clinicians at the FEP clinics in North Carolina will train and supervise all Horyzons peer support specialists, 
and will also be asked to provide feedback through participation in focus groups. 
 
Interactive psychosocial interventions. Horyzons includes a range of tailored interactive 
psychoeducation pathways divided into separate steps. These pathways target key risk factors and salient 
domains in the early recovery process including: (a) managing symptoms of (social) anxiety, (b) developing 
strategies to cope with depressive symptoms, and (c) improve social skills and functioning. Individuals are 
able to select which pathways they would like to utilize based on their treatment goals. All pathways are 
available to all participants in this study. 
 
Expert Moderation. Peer support specialists, clinicians with significant experience in the psychosocial 
treatment of FEP clients, as well as graduate students with relevant clinical/research experience with 
individuals with psychosis will serve as expert moderators. Their role is to provide guidance, monitor 
participants’ clinical status and ensure the safety of the social networking environment. The moderator 
reviews interactivity in the social networking space and information from individual participants’ modules 
to monitor clinical risk. The Horyzons Moderation Checklist will be completed by each moderator every 
time he/she moderates the platform. The checklist is designed to ensure moderators complete the 
appropriate safety checks during the moderation session, and to give moderators ideas as to how to 
engage users. 
 
Treatment period. Participants in both cohorts will complete study assessments at baseline, mid-
treatment, and post-treatment. Participants in the second cohort will complete two additional 
assessments before and after mid-treatment assessment at 1.5 months and 4.5 months following baseline, 
respectively.  
 
For all administration of assessments/interviews, the study coordinator will use screen sharing via 
secure videoconferencing to complete measures with the participant. Baseline assessment will be 
completed alongside the review and completion of informed consent and onboarding of participants onto 
the Horyzons platform. Participants will complete a mid-treatment assessment with the study coordinator 
or other trained research assistant, which corresponds to approximately 6-8 weeks after onboarding in the 
first cohort and approximately 12 weeks after onboarding in the second cohort. Participants will also meet 
with the study coordinator or other trained research assistant for a post-treatment assessment after 
clients have engaged with the platform for 12 weeks in the first cohort and 26 weeks in the second cohort. 
At post-treatment, both clients and clinicians (procedures described below) will be provided with an 
optional feedback form as a way of better understanding their experience with the platform and collecting 
suggestions for improving the site. Individual feedback interviews with clients will also be completed at 
post-treatment, lasting 60 minutes. These interviews will address participants’ social relationships, 
experiences with loneliness, and thoughts about connecting with others through Horyzons. 

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In order to evaluate the extent to which engagement in Horyzons may have impacted participants' 
perceptions of their social environment, participants will be asked to complete brief psychological 
measures. In the first cohort at baseline, mid-treatment (6-8 weeks), and post-treatment (12 weeks), 
participants will complete measures of loneliness (UCLA Loneliness Scale), social support (MOS Social 
Support Survey), social anxiety (Social Interaction Anxiety Scale), recovery (short form PWS - Psychological 
Wellbeing Scale), and therapeutic alliance (WAI-I and Perceived Autonomy Support Scale). 
 
The second cohort will complete all aforementioned measures at baseline, mid-treatment (12 weeks), and 
post-treatment (26 weeks) alongside additional measures of personal recovery (Questionnaire about the 
Process of Recovery), social anxiety related to use of social media (Social Anxiety Scale for Social Media 
Users), and self-report psychological symptomatology (Modified Colorado Symptom Index). A self-report 
measure of engagement (Twente Engagement with Ehealth Technologies Scale) will be completed at 
baseline, mid-treatment, and post-treatment as well as at two additional timepoints: 1.5 months and 4.5 
months following baseline. Measures of therapeutic alliance (WAI-I and Perceived Autonomy Support 
Scale) will be administered at 1.5 months, mid-treatment, 4.5 months, and post-treatment only. As this 
platform will be provided as part of clients' routine clinical care, we will also share clinical impressions and 
other relevant clinical information to the clinical team at the client's respective FEP clinic. 
 
Feedback from providers or staff (i.e., program directors, clinicians, peer specialists) will be collected 
through focus groups (lasting 60-75 minutes). Prior to initiating the focus groups, providers will complete a 
brief survey which will include (a) general feedback questionnaire about Horyzons and (b) service mapping 
questions; regarding the latter, program directors and clinicians/peer specialists will complete separate 
service mapping questionnaire specific their roles. In the qualitative focus groups, all providers will be 
asked to provide feedback about their perceptions of their clients’ experiences using the platform, and will 
also be asked to provide opinions about facilitators/barriers to engagement and challenges to 
implementing and disseminating the Horyzons platform within the clinic. All individual interviews and 
focus group feedback sessions will be conducted virtually via secure videoconferencing and will be led by 
the Horyzons study coordinator and/or a graduate student in clinical psychology at UNC-Chapel Hill. All 
feedback sessions will be digitally recorded, and will be de-identified and transcribed by a member of the 
research team or by a transcription service. The purpose of these recordings and transcriptions is to allow 
the research team to examine the feedback provided in the focus groups for the purposes of improving the 
process of integrating this type of treatment in clinics that provide mental health care to individuals with 
first episode psychosis. 
 
2.2 SUBJECTS 
For the first cohort of participants, up to 50 total study subjects will be recruited from the four FEP 
clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE), including up to 30 FEP clients and 20 FEP 
providers (clinicians and PSS). For the second cohort of participants, up to 80 total study subjects will be 
recruited from the four FEP clinics in North Carolina as well as the UNC-affiliated STEP clinics, including up 
to 60 FEP clients and 20 FEP providers (clinicians and PSS).  All clients who enroll in the study will have a 
primary diagnosis of a schizophrenia spectrum disorder. Demographic and clinical information that will be 

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collected as self-report for possible use as covariates includes: 1) demographics: age, sex, ancestry, 
education, parent education; 2) health: smoking, substance use, current medications, and DUP. 
 
2.2.1 INCLUSION CRITERIA 
1. Clients must be between the ages of 16 and 35 
2. Clients must have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform 
disorder, or Unspecified Schizophrenia Spectrum or Other Psychotic disorder 
3. Clients must be receiving services at one of the four FEP clinics in North Carolina (OASIS, 
Encompass, Eagle, or SHORE) or one of the three UNC STEP-affiliated clinics (Carr Mill Mall, Vilcom 
Center, Main Wake Clinic) 
4. Clients must not have had thoughts of harming themselves in the month before enrollment 
5. Clients must not have been hospitalized for psychiatric reasons in the three months before 
enrollment 
6. Clients must not have had a psychiatric medication change in the month before enrollment 
7. Clients must have access to the internet through a phone, tablet, or computer 
 
2.2.2 EXCLUSION CRITERIA  
1. Clients who do not speak English will not be considered for enrollment 
2. Adult clients (18+ years old) with legal guardians (LARs) will not be considered for the study 
 
3   ASSESSMENT OF DATA 
At this stage of treatment development, specific outcomes include:  
1. Examining the feasibility and acceptability of implementing Horyzons at NC FEP clinics through the 
following objectives: 
• Assessing change in psychological measures across the three-month (cohort 1) and six-month 
(cohort 2) study period (primary) 
• Ability to meet our recruitment targets 
• Evaluation of the safety and privacy protocol 
• Evaluating frequency and types of engagement on Horyzons 
• Identifying barriers/facilitators to implementing Horyzons 
 
3.1  OUTCOMES 
There are no specific hypotheses associated with this study, as it is an exploratory implementation 
trial that will test the feasibility and acceptability of Horyzons as a supplementary intervention for 
individuals in FEP programs. 
 
4 STUDY PROCEDURES 
4.1  SCREENING/BASELINE PROCEDURES 

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4.1.1 SCREENING PROCEDURES 
The research study coordinator will communicate with clinicians and other members 
of the treatment team to explain the project and discuss eligibility criteria for the study. If 
agreed to by the clinical team at each site, the research team will review the clinical census 
at each clinic and/or identify potential participants (clients) via the EPIC system.  Clinical 
team members will be asked to review their current caseloads to identify potentially eligible 
participants (i.e., patients who are currently receiving services at OASIS, SHORE, Encompass, 
Eagle, or STEP clinics and are considered clinically stable without current active suicidal 
ideation). The study coordinator and research assistant will engage in discussion with the 
treatment team to help identify appropriate clients for inclusion in the project. When 
participants have been identified and expressed interest in participation to their clinician or 
other treatment provider, the research study coordinator or RA will reach out to the client 
in their preferred method of contact (i.e., in person at the clinic or via phone/email) to 
discuss the project and complete an initial screen to confirm the inclusion and exclusion 
criteria. 
 
If clients self-refer (in response to flyers), the RA and PI will consult with their treatment 
team first before screening the client (i.e., to make sure there are no issues that prevent 
them from safely participating in the study). 
 
Clinicians will be consulted prior to each contact with a prospective participant and asked to 
advise the research team if any prospective participant should not be contacted. 
 
4.1.2 BASELINE PROCEDURES 
The study coordinator will meet virtually with client participants for approximately 1 
hour to complete all baseline measures. Informed consent and HIPAA authorization will be 
completed first, followed by a demographic form collecting basic information about sex, 
age, ancestry, education (including parent education levels), cigarette/alcohol use, and 
basic history of medication/psychosis (including DUP). After completing these documents, 
the study coordinator will guide participants through virtual copies of the UCLA Loneliness 
Scale, MOS Social Support Survey, SIAS, and short form PWS. Participants in the second 
cohort only will complete additional baseline measures (e.g., Questionnaire about the 
Process of Recovery, Modified Colorado Symptom Index, Social Anxiety Scale for Social 
Media Users, Twente Engagement Questionnaire). Once all baseline study measures are 
complete, the study coordinator will guide clients through a 20-30 minute orientation to the 
Horyzons platform, including creating their personal profile and learning the features of the 
site. Client participants will be paid $15.00 via Visa gift card for this hour of their time. 
 
4.2 INTERVENTION PERIOD PROCEDURES 
4.2.1 MID-TREATMENT PROCEDURES 

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The study coordinator will meet virtually with client participants for approximately 
30 minutes to complete the mid-treatment measures. Client participants will complete 
virtual copies of the UCLA Loneliness Scale, MOS Social Support Survey, SIAS, short form 
PWS, WAI-I, and Perceived Autonomy Support Scale. Participants in the second cohort only 
will complete additional measures at mid-treatment (e.g., Questionnaire about the Process 
of Recovery, Modified Colorado Symptom Index, Social Anxiety Scale for Social Media Users, 
Twente Engagement Questionnaire). Client participants will be paid $7.50 via Visa gift card 
for this 30 minutes of their time. 
 
4.2.2 POST-TREATMENT PROCEDURES 
The study coordinator will meet virtually with client participants for approximately 
1-1.5 hours to complete the post-treatment measures. Client participants will complete 
virtual copies of the UCLA Loneliness Scale, MOS Social Support Survey, SIAS, short form 
PWS, WAI-I, and Perceived Autonomy Support Scale. Participants in the second cohort only 
will complete additional measures at post-treatment (e.g., Questionnaire about the Process 
of Recovery, Modified Colorado Symptom Index, Social Anxiety Scale for Social Media Users, 
Twente Engagement Questionnaire). After completing these virtual measures, the study 
coordinator will lead client participants through a feedback survey and individual feedback 
interview regarding the Horyzons platform, their online therapist, the PSS, and the 
community newsfeed. Client participants will be welcomed to share their opinions 
regarding their experience, including suggestions for how to improve Horyzons in the 
future. 
 
4.2.3 ADDITIONAL ASSESSMENT PROCEDURES 
For participants in the second cohort only, the study coordinator will meet virtually 
with client participants for approximately .5 hours to complete the measures at 1.5 months 
following baseline (i.e., between baseline and mid-treatment visits) and 4.5 months 
following baseline (i.e., between mid-treatment and post-treatment visits). Participants in 
the second cohort only will complete virtual copies of the WAI-I, Perceived Autonomy 
Support Scale, and Twente Engagement Questionnaire. Client participants will be paid $7.50 
via Visa gift card for this 30 minutes of their time. 
 
4.3 FOCUS GROUPS 
Clinicians and PSS from the four FEP clinics in North Carolina will take part in small focus groups 
to discuss the feasibility and acceptability of Horyzons as a supplementary intervention at NC FEP 
clinics. Providers will complete informed consent and a demographic form collecting basic 
information about their age, sex, race, current position at the clinic, and years of experience in the 
mental health field over secure Zoom with the study coordinator before being assigned to a focus 
group. Focus groups will begin with a short feedback survey followed by a group interview led by the 

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study coordinator. Each group should take approximately 1 hour to complete, and clinician 
participants will be compensated $20 via Visa gift card for their time. 
 
5  DATA ANALYTIC PLAN 
5.1 PRIMARY OUTCOME MEASURES 
1. Mean Change in UCLA Loneliness Scale Score (Both Cohorts) [Time Frame: up to 6 months] 
The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I 
often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this 
way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater 
feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit. The UCLA 
Loneliness Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up 
to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
 
2. Mean Change in Medical Outcomes Study (MOS) Social Support Survey – Total Score (Both 
Cohorts) [Time Frame: up to 6 months] 
The MOS Social Support Survey is a 19 item scale. Answers are on a 5 point scale with options 
"none of the time", "a little of the time", "some of the time", "most of the time", and "all of the 
time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social 
support (more perceived social support). The MOS Social Support Survey is a part of the PhenX 
Toolkit. The MOS Social Support Survey is administered in both cohort 1 (Baseline, Mid-
treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
 
5.2 SECONDARY OUTCOME MEASURES 
 
1. Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts) [Time Frame: up to 6 
months] 
 
The Social Interaction Anxiety Scale (SIAS) is a 20 item scale. Answers are on a 4 point scale 
starting at 0 with options "none at all", "slightly", "moderately", "very", and "extremely". 
Possible scores range from 0 to 80. Higher scores reflect higher levels of social anxiety. Scoring 
a 43 or higher may indicate a diagnosis of social anxiety, and scores between 34 and 42 may 
indicate social phobia(s). The SIAS is administered in both cohort 1 (Baseline, Mid-treatment, 
Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 
6 months). 
 
2.   Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts) [Time 
Frame: up to 6 months] 
 

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The Psychological Wellbeing Scale (Short Form) is an 18 item scale. Answers are on a 6 point 
scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly 
agree", "moderately agree", and "strongly agree". Possible scores range from 18 to 108. Higher 
scores reflect higher levels of psychological wellbeing. The Psychological Wellbeing Scale is 
administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and 
cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
 
 
5.3 TERTIARY/EXPLORATORY OUTCOME MEASURES 
1. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational 
Support Subscale Score (Both Cohorts) [Time Frame: up to 6 months] 
The MOS Social Support Survey - Emotional/informational support subscale is an 8 item 
subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", 
"some of the time", "most of the time", and "all of the time". Possible scores range from 8 to 
40. Higher scores reflect higher feelings of emotional and informational social support (more 
perceived emotional and informational social support). The MOS Social Support Survey - 
Emotional/informational support subscale is administered in both cohort 1 (Baseline, Mid-
treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
2. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support 
Subscale Score (Both Cohorts) [Time Frame: up to 6 months] 
The MOS Social Support Survey - Tangible support subscale is a 4 item subscale. Answers are on 
a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most 
of the time", and "all of the time". Possible scores range from 4 to 20. Higher scores reflect 
higher feelings of tangible social support (more perceived tangible social support). The MOS 
Social Support Survey - Tangible support subscale is administered in both cohort 1 (Baseline, 
Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
3. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support 
Subscale Score (Both Cohorts) [Time Frame: up to 6 months] 
The MOS Social Support Survey - Affectionate support subscale is a 3 item subscale. Answers 
are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", 
"most of the time", and "all of the time". Possible scores range from 3 to 15. Higher scores 
reflect higher feelings of affectionate social support (more perceived affectionate social 
support). The MOS Social Support Survey - Affectionate support subscale is administered in 
both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 
(Baseline, Mid-treatment, Post-treatment, up to 6 months). 

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3. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social 
Interaction Subscale Score (Both Cohorts) [Time Frame: up to 6 months] 
The MOS Social Support Survey - Positive social interaction subscale is a 3 item subscale. 
Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of 
the time", "most of the time", and "all of the time". Possible scores range from 3 to 15. Higher 
scores reflect higher feelings of positive social interaction (more perceived positive social 
interaction). The MOS Social Support Survey - Positive social interaction subscale is 
administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and 
cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
4. Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale 
Score (Both Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Environmental Mastery Subscale is a 3 item 
scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", 
"slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores 
range from 3 to 18. Higher scores reflect higher levels of environmental mastery. The MOS 
Social Support Survey - Environmental Mastery subscale is administered in both cohort 1 
(Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-
treatment, Post-treatment, up to 6 months). 
5. Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score 
(Both Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Personal Growth subscale is a 3 item scale. 
Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly 
disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range 
from 3 to 18. Higher scores reflect higher levels of personal growth. The Psychological 
Wellbeing Scale - Personal Growth subscale is administered in both cohort 1 (Baseline, Mid-
treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
6. Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score (Both 
Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Self-Acceptance subscale is a 3 item scale. 
Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly 
disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range 
from 3 to 18. Higher scores reflect higher feelings of self-acceptance. The Psychological 
Wellbeing Scale - Self-Acceptance subscale is administered in both cohort 1 (Baseline, Mid-
treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 

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7. Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score (Both 
Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Autonomy Subscale is a 3 item scale. Answers 
are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly 
disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range 
from 3 to 18. Higher scores reflect higher levels of autonomy. The Psychological Wellbeing Scale 
- Autonomy subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-
treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 
months). 
8. Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score 
(Both Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Positive Relationships subscale is a 3 item 
scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", 
"slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores 
range from 3 to 18. Higher scores reflect higher levels of positive relationships. The 
Psychological Wellbeing Scale - Positive Relationships subscale is administered in both cohort 1 
(Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-
treatment, Post-treatment, up to 6 months). 
9. Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score (Both 
Cohorts) [Time Frame: up to 6 months] 
The Psychological Wellbeing Scale (Short Form) - Purpose in Life subscale is a 3 item scale. 
Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly 
disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range 
from 3 to 18. Higher scores reflect higher feelings of purpose in life. The Psychological 
Wellbeing Scale - Purpose in Life subscale is administered in both cohort 1 (Baseline, Mid-
treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
10. Qualitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts) 
[Time Frame: up to 6 months] 
This qualitative data will be collected post-treatment from clients and clinicians. Focus groups 
and individual interviews will discuss usage of the platform and any feedback participants may 
have. Feedback from participants will be summarized to include common themes regarding 
likes and dislikes of the platform, implementation within the clinical setting, and participant 
ideas for future directions. Feedback is elicited at post-treatment in both cohort 1 (Month 3) 
and cohort 2 (Month 6). 

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11. Quantitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts) 
[Time Frame: up to 6 months] 
This quantitative data will be collected post-treatment from clients and clinicians. Feedback 
forms will prompt participants to answer questions regarding their experience with the 
platform on a scale of 1 to 5, with higher scores reflecting a more positive experience. 
Frequency counts will be included here. Feedback is elicited at post-treatment in both cohort 1 
(Month 3) and cohort 2 (Month 6). 
12. Mean Change in Questionnaire about the Process of Recovery - Total Score (Cohort 2 Only) [Time 
Frame: up to 6 months] 
The Questionnaire about the Process of Recovery (QPR) - Total Score is a 15-item scale. 
Answers are rated on a 5-point scale with options "disagree strongly", "disagree", "neither 
agree nor disagree", "agree", and "agree strongly. Possible scores range from 0 to 60. Higher 
scores are indicative of recovery. The QPR is administered in only cohort 2 (Baseline, Mid-
treatment, Post-treatment, up to 6 months). 
13. Mean Change in Modified Colorado Symptom Index - Total Score (Cohort 2 Only) [Time Frame: up 
to 6 months] 
The Modified Colorado Symptom Index - Total Score is a 14-item scale. Answers are rated on a 
4-point scale with options "not at all", "once during the month", "several times during the 
month", "several times a week", and "at least every day". Possible scores range from 0 to 56. 
Higher scores indicate greater emotional distress. The Modified Colorado Symptom Index is 
administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
14. Mean Change in Social Anxiety Scale for Social Media Users - Total Score (Cohort 2 Only) [Time 
Frame: up to 6 months] 
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Total Score is a 21-item scale. 
Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and 
"always". Possible scores range from 21 to 105. Higher scores reflect greater anxiety related to 
social media usage. The SAS-SMU is administered in only cohort 2 (Baseline, Mid-treatment, 
Post-treatment, up to 6 months). 
15. Mean Change in Social Anxiety Scale for Social Media Users - Shared Content Anxiety Subscale 
Score (Cohort 2 Only) [Time Frame: up to 6 months] 
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Shared Content Anxiety subscale is 
a 7-item scale. Answers are rated on a 5-point scale with options "never", "rarely", 
"sometimes", "often", and "always". Possible scores range from 7 to 35. Higher scores reflect 
greater anxiety related to sharing or creating content on social media. The SAS-SMU - Shared 

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Content Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-
treatment, up to 6 months). 
16. Mean Change in Social Anxiety Scale for Social Media Users - Privacy Concern Anxiety Subscale 
Score (Cohort 2 Only) [Time Frame: up to 6 months] 
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Privacy Concern Anxiety subscale is 
a 5-item scale. Answers are rated on a 5-point scale with options "never", "rarely", 
"sometimes", "often", and "always". Possible scores range from 5 to 25. Higher scores reflect 
greater anxiety related to privacy concerns on social media. The SAS-SMU - Privacy Concern 
Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up 
to 6 months). 
17. Mean Change in Social Anxiety Scale for Social Media Users - Interaction Anxiety Subscale Score 
(Cohort 2 Only) [Time Frame: up to 6 months] 
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Interaction Anxiety subscale is a 6-
item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", 
"often", and "always". Possible scores range from 6 to 30. Higher scores reflect greater anxiety 
related to social interactions over social media. The SAS-SMU - Interaction Anxiety subscale is 
administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
18. Mean Change in Social Anxiety Scale for Social Media Users - Self-Evaluation Anxiety Subscale 
Score (Cohort 2 Only) [Time Frame: up to 6 months] 
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Self-Evaluation Anxiety subscale is a 
3-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", 
"often", and "always". Possible scores range from 3 to 15. Higher scores reflect greater anxiety 
related to negative self-evaluation. The SAS-SMU - Self-Evaluation Anxiety subscale is 
administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months). 
19. Mean Change in Perceived Autonomy Support Scale - Total Score (Both Cohorts) [Time Frame: up 
to 20 weeks] 
The Perceived Autonomy Support Scale - Total Score is a 6-item scale. Answer are on a 7-point 
scale with options "strongly disagree", "moderately disagree", "slightly disagree", "neutral", 
"slightly agree", "moderately agree", and "strongly agree". Possible scores range from 6 to 42. 
Higher scores reflect greater perceived autonomy support. The Perceived Autonomy Support 
Scale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and 
cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks). 
20. Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both 
Cohorts) [Time Frame: up to 20 weeks] 

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The Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score is a 12-
item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", 
"very often", and "always". Possible scores range from 12 to 60 (summed) or 1 to 5 (averaged). 
Higher scores reflect greater therapeutic alliance. The WAI-I is administered in both cohort 1 
(Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 
Months, Post-treatment, up to 20 weeks). 
21. Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale 
Score (Both Cohorts) [Time Frame: up to 20 weeks] 
The Working Alliance Inventory for Guided Internet Interventions - Bond subscale score is a 4-
item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", 
"very often", and "always". Possible scores range from 4 to 20 (summed) or 1 to 5 (averaged). 
Higher scores reflect greater bond with a clinician. The WAI-I - Bond subscale is administered in 
both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-
treatment, 4.5 Months, Post-treatment, up to 20 weeks). 
22. Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task 
Subscale Score (Both Cohorts) [Time Frame: up to 20 weeks] 
The Working Alliance Inventory for Guided Internet Interventions - Goal/Task Score is an 8-item 
scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very 
often", and "always". Possible scores range from 8 to 40 (summed) or 1 to 5 (averaged). Higher 
scores reflect greater shared goals and tasks with a clinician. The WAI-I - Goal/Task subscale is 
administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 
(1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks). 
23. Mean Change in Twente Engagement with E-health Technologies Scale - Total Score (Cohort 2 
Only) [Time Frame: up to 6 months] 
The Twente Engagement with E-health Technologies Scale - Total Score is a 9-item scale. 
Answers are on a 5-point scale with options "strongly disagree", "disagree", "neutral", "agree", 
and "strongly agree". Possible scores range from 0 to 36. Higher scores reflect greater 
engagement. The Twente Engagement with E-health Technologies Scale is administered in only 
cohort 2 (Baseline, 1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months). 
 
5.4 POWER ANALYSIS 
We did not conduct a priori power calculations to determine a sample size with 80% power because 
this is an exploratory study and will inform future well-powered and randomized pilot trials of 
Horyzons in North Carolina. 
 
5.5 DATA MANAGEMENT 

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We will use the Research Electronic Data Capture (REDCap) system to facilitate data entry and 
management. We will leverage features in REDCap such as real-time data validation, built-in integrity 
checks, and other mechanisms for ensuring data quality (i.e., double data entry). Our team will use 
the DeDoose program for qualitative analysis. All analyses will be conducted by the study research 
coordinator (Elena Pokowitz) and graduate student (Bryan Stiles).  
 
6 RISKS AND BENEFITS 
Risks for all participants. Identifying research subjects by a study number on all research documents 
minimizes risk of breach of confidentiality. Study documents that must contain personal information, such as 
the document that links study ID number to personal identifying information (necessary due to the 
longitudinal nature of this study) are kept in locked filing cabinets in locked rooms. Research data is kept on 
password-protected drives, and our computer systems are HIPAA compliant. All study staff participate in 
annual human subjects training that includes education about responsibilities to minimize risk that 
confidentiality may be breached. 
 
Risks for clients only. Risk of anxiety, paranoia, and/or shame/embarrassment due to experiences using 
this online platform is minimized by completion of a Horyzons induction procedure. This will also be mitigated 
through the use of consistent moderating of the site as well as moderators’ use of a nonjudgmental clinical 
attitude. The informed consent process will be completed in private spaces within the clinic/research setting 
or via video conferencing will be done in secure locations and on secure servers. The participant will be 
instructed via email or phone call before the interview to find a private location to complete the induction to 
the platform. All documents such as consent and feedback measure/questionnaire will be sent to the 
participant using a secure UNC email account. Documents will not contain confidential information. 
 
Risks for providers only. The informed consent process will be completed in private spaces within the 
clinic/research setting or via video conferencing will be done in secure locations and on secure servers. 
Providers will be instructed via email or phone call before the focus groups to identify an appropriate location 
for the group discussion (i.e., private space) if held virtually rather than in person. All documents such as 
consent documents will be sent to providers using a secure UNC email account. Documents will not contain 
confidential information. 
 
6.1 Monitoring Risks 
To address subject anxiety or embarrassment due to revealing person information, we have trained 
research staff who are experienced in working with individuals with schizophrenia spectrum disorders. 
They have been trained to put subjects at ease, let them take their time, and to conduct interviews in 
private rooms.  
 
To address the issue of accidental disclosure of personal information to others outside of the 
research staff, we will identify research subjects by study number on all research documents to minimize 
the risk of breach of confidentiality. Study documents that must contain personal information, including 
the informed consent document, and the document that links study ID number to personal identifying 
information are kept in locked filing cabinets in locked rooms. Research data will be kept on password-

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protected drives, and our computer systems are HIPAA compliant. All study staff participate in annual 
human subject training that includes education about responsibilities to minimize risk that confidentiality 
may be breached.  
 
Online safety. Privacy and online safety will be managed in accordance with the 'Online social 
networking' guidelines published by 'Cybersmart', a national cybersafety and cybersecurity education 
program managed by the Australian Communications and Media Authority (ACMA). Cybersmart is 
designed to meet the needs of its target audiences young people, parents, teachers and library staff. 
Information about Cybersmart can be found at http://www.cybersmart.gov.au/, while the guidelines are 
available at http://www.acma.gov.au/. 
 
Safe and informed orientation to the system  will be a priority for the research team. Peer support 
specialists, clinicians, and/or a graduate student in the Department of Psychology and Neuroscience at 
UNC-CH will meet with each participant to provide them with login information, help set up their account 
and orient them to the Horyzons system, including details of the terms of use. All users of Horyzons will be 
asked to nominate an emergency contact person, such as a close family member. The terms of use explain 
to users that information passed onto moderators or communicated within the system that may indicate 
concerns regarding their wellbeing may be communicated with their treating team or private practitioner. 
Hard copies of  ‘Horyzons Terms of Use’  will be provided to users which will be made available online and 
in printed form. Participants will be required to sign the hard copy as well as accepting the terms of use on 
entry into the system. The system also includes a "report function" which enables users at any time to 
indicate to the moderator a concern about any material posted by a user, including concern about 
potential abuse or concerns about the well being of another participant. The moderator will assess the 
basis of the report and respond accordingly, which can include the removal of the material or deactivation 
of an account.   
 
In addition, users will be able to "switch off" their profile and hide all of their existing comments on 
the system should they become concerned about their privacy during their course of participation. The 
limits of the moderator to respond (e.g., in a timely manner to emergencies) will also be fully explained. In 
order to protect the privacy of users who discontinue using the system, any accounts that have not been 
activated for one month may be deactivated following a follow-up telephone call from the moderator. 
Specifically, our disengagement protocol is such that a participant will receive an email/call/text message if 
they have not logged onto the platform for two weeks. If another two weeks pass, we will call this person 
to check in about any potential issues or concerns. If participants do not comply with the guidelines for 
safe use of Horyzons (e.g., discriminatory comments towards other users) they will be excluded from the 
system. 
 
Clinical safety. Clinical risk will be managed through manual and automated procedures. Information 
related to clinical risk will be screened twice daily by moderators (in the morning and late 
afternoon/evening). This information can include: 1) post made by participants, which disclose evidence of 
psychotic, depressive or suicidal symptoms; 2) participants reports or complaints of posts made by other 
users; 3) risk or self-harm related words automatically detected and blocked by the system; and 4) 

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presence of Early Warning Signs of relapse detected by the regular monitoring of psychotic symptoms 
implemented within Horyzons. 
 
Any detected increased risk will activate the Horyzons crisis protocol which includes a number of 
potential actions. Initially, the moderator will conduct a risk assessment based upon available information, 
inform the research team, and emergency contact nominated by the participant, and liaise with suitable 
emergency services where necessary. In addition, the system incorporates visible emergency guidelines 
and contact information (i.e., on every webpage). 
 
An automated keyword system has also been built in Horyzons which will be activated each time a 
participant posts a contribution containing the words or phrases: suicide, die, kill 
myself/you/him/her/them, hang myself/you/him/her/them, harm myself/you/him/her/them, snort, shoot 
up, burn myself/you/him/her/them, cut myself, drown myself/you/him/her/them, stab 
myself/you/him/her/them, slit, slice, electrocute, shoot myself/you/him/her/them, top myself, jump in 
front of, jump off, end it all, sleep and never wake up, death, die, asphyxiate, or gas. When these words 
are detected the contribution will be blocked and the participant will be sent an automated message 
explaining that the content has been blocked and if they are facing distress then they should contact the 
emergency contact number as soon possible or if they are not facing distress they may like to consider 
rephrasing their post. An automated message will also be sent to the Horyzons moderator containing the 
attempted post. 
 
In addition, a message will be available on each page providing a cell phone number carried by a 
member of the research team for any emergencies that are related specifically to the use of the Horyzons 
system (e.g., highly inappropriate use of the system). Further, each page includes an "In case of 
emergency" link that provides information about ways to contact emergency services (911), the UNC crisis 
line (984-974-3950), and crisis services ( http://crisissolutionsnc.org/). 
 
6.2 NON-SIGNIFICANT RISK DOCUMENTATION 
The present study has been deemed of non-significant risk (NSR) to participants. 
 
6.3 POTENTIAL BENEFITS OF THE RESEARCH TO SUBJECTS AND OTHERS 
While the field is still in its infancy, there is preliminary evidence that online interventions that 
combine therapy, social networking opportunities and expert and peer moderation may be better received 
by individuals with first episode psychosis than less integrated approaches. The proposed study will 
expand this growing body of work by testing the clinical utility of this intervention when implemented as 
part of mental health care at first episode clinics in North Carolina. 
 
Benefits to clients. The proposed study may increase clients’ sense of belonging and social support. 
Also, if they engage in the therapeutic pathways, they might develop cognitive behavioral and 
mindfulness-based skills. 
 

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Benefits to providers. Clinicians and peer support specialists may gain insight into clients’ experiences 
using the platform, including possible barriers to engagement and challenges to disseminating the 
Horyzons platform within the clinic. This information may prove useful to clinicians as they consider ways 
to incorporate online interventions and other adjunct services into their existing treatment approaches in 
the future. 
 
6.4 CONFIDENTIALITY OF DATA 
Names and associated contact information for potential subjects during the recruitment phase will 
be stored in a manner similar to that used to store study data. This information will be kept in a locked file 
cabinet in a locked office in the Department of Psychology and Neuroscience at UNC or within the 
administrative or secure storage areas of the FEP clinics involved in this project. Contact information will 
be destroyed immediately after it is ascertained that an individual does not want to participate in the 
study. Declining participants’ names will be retained on a secure password protected network to ensure 
that the same participant is not contacted more than once regarding participation. 
 
A member of the research team will meet individually with the client in order to explain the components 
of the Horyzons platform, elicit and answer any questions the client may have, and obtain informed 
consent. We will also collect information about current suicidal ideation and stability (e.g., recent 
hospitalizations) to assess eligibility for participation.  Persons will also be creating a Horyzons profile and 
answering questions about character strengths (e.g., curiosity, love of learning), which are embedded in 
the Horyzons platform.  These data will be linked to other sources of information, including the record of 
their interactions within the Horyzons system (e.g., number of posts/comments on the cafe). 
 
The Horyzons system and data generated by users of Horyzons will be hosted on a secure web server. A 
range of measures are in place to ensure the security of the Horyzons website and the data generated by 
users. In addition, the team who developed the web application has placed measures within the 
application to secure the application and database against unauthorized access. These measures conform 
to industry best practice as defined by the Open Web Application Security Project (www.OWASP.org). 
Feedback interviews/focus groups will be conducted via secure Zoom, and will be digitally recorded (via 
Zoom or using audio recorders) for the purposes of transcription. These recordings and transcripts will be 
immediately uploaded to a secure,  password-protected server and deleted from local devices. The project 
electronic database (including all transcripts from interviews/focus groups) will be password protected and 
stored securely, and will only be directly accessible by the research study coordinators, clinicians and peer 
support specialists, involved in this project, or PI (Dr. Penn). 
 
As this research program is being implemented in clinical settings, it is possible that FEP clinicians will 
create notes that indicate the participant is involved in the project, describe any issues may arise, etc. that 
will be connected to their medical record. These documents will be stored in approved medical record 
systems on HIPAA-compliant computers.  If researchers complete inductions or introductions to the site 
via video conference, the video or audio from these interviews will not be saved or recorded. Audio from 
qualitative interviews and focus groups will be stored on a secure, password-protected server.  
 

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Identifiable data will only be shared with the clinicians of subjects in the study with the permission of the 
subjects (obtained during informed consent). Clinicians will be contacted if issues arise related to safety 
during the trial. As part of the informed consent process, all subjects will provide the name and contact 
info of a clinician that we may contact if we become concerned about their safety (e.g., physical and/or 
mental health) during the course of the trial. We will not be sharing any confidential information with 
anybody outside of these clinicians. 
 
Identifiable data will be maintained for 5 years following study completion. At that point, hard copies of 
identifiable data including consent forms and contact information will be shredded. Electronic data will be 
de-identified upon entry, with the exception of the subjects' birth dates for the purposes of calculating 
their exact age. 
 
7 
SAFETY MANAGEMENT 
7.1 ADVERSE EVENTS 
Client activity on the platform will be monitored daily by the online moderators and PSS. Signs of 
potential clinical deterioration will be reported to the client’s treatment team. It is highly unlikely that 
clinical deterioration will be attributable to the Horyzons system. However, in the event that this becomes 
evident (e.g., a participant has clearly communicated that they have incorporated aspects of the Horyzons 
system into their delusional beliefs) the moderator will communicate this information to the clinical 
treatment team and/or the principal investigator. The principal investigator will inform the IRB of any 
concerns regarding adverse events associated with involvement in Horyzons. 
 
7.2 SERIOUS ADVERSE EVENTS 
Adverse events (AE) will be assessed to determine if they meet criteria for a serious adverse events 
(SAE). SAE, as defined by the FDA, will be systematically evaluated at each clinic visit. The trial period is 
defined from the time that the informed consent document is signed until 30 days after the last study visit. 
All SAE occurring during the trial period (including death due to any cause) or within 30 days after the last 
study visit will be communicated within 1 day of the investigator becoming aware of the event to 
designated personnel, using the telephone or fax numbers provided in the Study Reference Manual. Any 
fatal or life-threatening AE will be reported immediately, but no longer than 1 day from the time the 
investigator becomes aware of the event. A causality assessment will be provided for all SAEs. Critical 
follow-up information on SAEs will be provided as soon as it is available, but no longer than 1 day from the 
time the investigator became aware of the information. Other essential, but not critical, information may 
be reported within the following 5 days. An SAE, as defined by the FDA for use in clinical trials 
https://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm), is an adverse event that satisfies 
any of the following criteria: 
• Results in death. 
• Is immediately life-threatening, including potentially life threatening suicidal behavior or 
suicidal behavior that results in hospitalization. 
• Requires inpatient hospitalization or prolongation of existing hospitalization. 
• Results in persistent or significant disability or incapacity. 
• Is a congenital abnormality or birth defect. 

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• Is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. Examples would include allergic 
bronchospasm that requires treatment in an emergency department, or a seizure that does not 
result in hospitalization. 
The causality of SAEs (i.e., their degree of relatedness to study treatment) will be assessed by the 
investigators. 
 
7.3 DEATH 
All deaths occurring within the trial period or within 30 days after the last day that the study 
intervention is administered will be reported within 1 day of the investigator becoming aware of the event. 
If an autopsy has been performed, results of the autopsy will be obtained and forwarded along with any 
available toxicology reports. 
 
8 
RECRUITMENT STRATEGY 
 
Study subjects will be drawn from the four first episode psychosis clinics in North Carolina (OASIS, 
Encompass, SHORE, and Eagle) and the UNC-affiliated STEP clinics (Carr Mill Mall, Vilcom Center, Main Wake 
Clinic).  The OASIS clinic was co-developed by Dr. Penn for the treatment of people with first episode 
schizophrenia. Currently, each clinic has a census of approximately 100-150 people and admits approximately 
3-5 people per month. Approximately 30 client participants will be recruited from the four clinics, or around 6-
8 client participants per clinic. Additionally, all providers have been self-identified as clinicians or PSS providing 
services to clients at one of the four participating clinics; therefore, we expect approximately 20 providers to 
participate in this project. As such, we expect that we will be able to recruit the number of participants we 
would like to involve in this project. 
 
Once a client is referred to the study (or self refers), a study clinician or research assistant will speak with the 
individual (and any other individuals that she/he indicates, such as a family member) to describe the study 
protocol, expectations of study participation and potential study risks and benefits. If a client contacts a 
member of the research project to indicate interest in the study, a member of the research team will explain 
the study over the phone and use the screening questions to assess for potential eligibility. Providers will be 
contacted by phone and/or email in order to obtain consent and schedule focus groups. 
 
Recruitment will be completed by the study coordinator, research assistant, and/or clinical providers involved 
in this project.  The latter includes peer support specialists and clinicians at the local FEP clinics. 
 
9 CONSENT PROCESS 
Research staff will obtain informed consent directly from each subject. Staff obtaining the consent will 
provide the subject with a written document explaining the testing procedures and risks, and will answer any 
questions. We have several procedures in place to ensure that prospective participants fully understand the 
procedures, risks, and protections of the study. First, the consent form is written in easy to understand 
language. Second, the researcher reads the form to and with the potential subject, and invites questions after 
each section of the form. Third, the researcher asks the subject a series of questions about the study, such as 
what they are to do if they no longer want to participate, or what they would do if they experience any stress 

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during the protocol (this is to be used as comprehension check before consenting). As Horyzons is a fully 
virtual research study, participants will provide verbal consent as recorded by the study coordinator.  

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10 
REFERENCES  
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Preventing the second episode: a systematic review and meta-analysis of psychosocial and 
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psychiatry, 196(5), 372-376. 
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Symptom and functional outcomes for a 5 year early intervention program for 
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7. Alvarez-Jimenez, M., Bendall, S., Lederman, R., Wadley, G., Chinnery, G., Vargas, S., ... & 
Gleeson, J. F. (2013). On the HORYZON: moderated online social therapy for long-term recovery 
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