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

 
Horyzons: Implementation and Integration in Clinical Practice 
 
 
 
 
 
NCT number NCT06002958 
Document Date 05/14/2025 
 

Clinical Protocol & Data Analytic Plan 
 
 
Horyzons: Implementation and Integration in Clinical Practice 
 
 
Version 3.5 
Protocol Date: May 14, 2025 
 
 
 
David Penn, PhD 
Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) 
Chapel Hill, NC, 27514 
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 
HORYZONS: IMPLEMENTATION AND INTEGRATION IN CLINICAL PRACTICE ...................... 1 
ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................................................................................................................ 3 
PROTOCOL SYNOPSIS ............................................................................................................................................................................... 4 
1 BACKGROUND AND RATIONALE ................................................................................................................................................ 7 
2 RESEARCH DESIGN AND METHODS............................................................................................................................................ 8 
2.1 OVERVIEW ................................................................................................................................................................................. 8 
2.2 SUBJECTS ..................................................................................................................................................................................... 9 
2.2.1 INCLUSION CRITERIA ........................................................................................................................................................... 9 
2.2.2 EXCLUSION CRITERIA ........................................................................................................................................................ 10 
3  ASSESSMENT OF DATA ................................................................................................................................................................. 10 
3.1 OUTCOMES................................................................................................................................................................................ 10 
4 STUDY PROCEDURES .................................................................................................................................................................... 10 
4.1 SCREENING & BASELINE PROCEDURES .......................................................................................................................... 10 
4.1.1 SCREENING PROCEDURES ................................................................................................................................................ 10 
4.1.2 BASELINE PROCEDURES .................................................................................................................................................... 11 
4.2 INTERVENTION PERIOD PROCEDURES ................................................................................................................................ 11 
4.2.1 MID-TREATMENT PROCEDURES ...................................................................................................................................... 11 
4.2.2 POST-TREATMENT PROCEDURES ..................................................................................................................................... 11 
4.3 CLIENT PROCEDURES ....................................................................................................................................................................... 12 
5 DATA ANALYTIC PLAN ................................................................................................................................................................. 12 
5.1 PRIMARY OUTCOME MEASURES ......................................................................................................................................... 12 
5.2 SECONDARY OUTCOME MEASURES .................................................................................................................................. 12 
5.3 POWER ANALYSIS .................................................................................................................................................................. 13 
5.4 DATA MANAGEMENT ........................................................................................................................................................... 13 
6 RISKS AND BENEFITS .................................................................................................................................................................... 13 
6.1 Monitoring Risks ............................................................................................................................................................................. 14 
6.2 NON-SIGNIFICANT RISK DOCUMENTATION .................................................................................................................... 15 
6.3 POTENTIAL BENEFITS OF THE RESEARCH TO SUBJECTS AND OTHERS .................................................................. 15 
6.4 CONFIDENTIALITY OF DATA .............................................................................................................................................. 16 
7 SAFETY MANAGEMENT ................................................................................................................................................................ 17 
7.1 ADVERSE EVENTS ................................................................................................................................................................ 17 
7.2 SERIOUS ADVERSE EVENTS ............................................................................................................................................... 17 
7.3 DEATH....................................................................................................................................................................................... 17 
8 RECRUITMENT STRATEGY........................................................................................................................................................... 18 
9 CONSENT PROCESS........................................................................................................................................................................ 18 
10 REFERENCES ................................................................................................................................................................................. 19 
 
 
 

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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 
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 
SSD 
Schizophrenia Spectrum Disorder 
 
 
 

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Protocol Synopsis 
Study Title 
Horyzons: Implementation and Integration 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 barriers and 
facilitators to implementing a moderated online social media platform 
with therapeutic content, Horyzons, as a part of routine care received at 
first-episode psychosis (FEP) clinics across North Carolina. 
Study Objective(s) 
Examine the implementation and integration Horyzons at NC FEP 
clinics as part of routine clinical care through the following objectives: 
1. Identifying the unique barriers and facilitators in implementing 
Horyzons at each FEP clinic as part of standard care and distinct 
implementation strategies 
2. Evaluate client engagement with Horyzons and attrition as part of 
clinical care across 12 months 
3. Assess change in clients’ psychological measures across 12 months 
and use of emergency and social services across 12 months prior 
and during engagement with Horyzons platform 
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 fs. 
Study Design 
 
This is an open trial enrolling both clients from NC FEP clinics and 
clinicians and PSSs. FEP clients will participate in the use of Horyzons, 
a novel digital intervention, which has previously demonstrated benefits 
to this population and complete psychological measures. FEP clinicians 
and PSSs will take part in qualitative interviews and surveys to identify 
unique barriers and enablers in integrating Horyzons as a clinical service 
within FEP clinics. 
Client Participants 
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 
3. Clients must be receiving services at one of the five FEP clinics 
in North Carolina (OASIS, Encompass, Eagle, SHORE, or 
AEGIS) or one of their stepdown outpatient clinics (STEP and 
TIDES) 
4. Clients must not have had thoughts of harming themselves in 
the month before enrollment 

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5. Clients must not have been hospitalized for psychiatric reasons 
in the three months before enrollment 
6. Clients must actively be engaging with medication management 
via their clinic or another provider 
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. Clients with legal guardians (LARs) will not be considered for 
the study 
Provider &/or PSS 
Participants 
Key Criteria for Inclusion and 
Exclusion: 
Inclusion Criteria 
1. Provider &/or PSS must be 18 years or older 
2. Provider &/or PSS must be currently serving clients within their 
FEP clinic 
3. Provider &/or PSS must be able to speak and read English 
Number of Subjects  
50 client participants with SSDs, 20 provider &/or PSS participants 
from NC FEP clinics 
Study Duration 
Each subject’s participation will last approximately 12 months from 
baseline to post-treatment. The entire study is expected to last 
approximately 24 months (including a 12-month recruitment period). 
Study Phases 
Screening 
Study Treatment 
Qualitative Interviews 
Screening- Completed prior to the first virtual appointment via a 
telephone screen to confirm study eligibility. 
Baseline- Client participants who are deemed eligible schedule a virtual 
appointment with the study coordinator to obtain consent, HIPAA 
authorization, and complete the baseline assessments (Demographics, 
Clinical Characteristics, & psychological measures). Client participants 
are then oriented to the Horyzons platform. Provider &/or PSS 
participants will complete consent, demographics and characteristics, 
and baseline survey, the adapted CPCRN Federally Qualified Health 
Centers Survey. 
Study Treatment- Client participants will be given access to the digital 
platform Horyzons for approximately 12 months. Weekly engagement 
is decided by the participant. Digital access is available daily, digital 
access to PSS and online therapists is made available daily, and virtual 
“Horyzons Hangs” are hosted over Zoom by PSS approximately twice 
each month. 
Provider &/or PSS participants will have the option to engage with the 
Horyzons platform to track their caseload’s interaction with the 
platform, along with other ways in order to integrate the platform 
within their care. 
Mid-treatment – Client participants will be asked to complete a short 
battery of measures (UCLA Loneliness Scale, MOS Social Support 
Survey, and Horyzons Feedback Survey) at the approximately 6-month 

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timepoint. Provider &/or PSS participants will be asked to complete 
CPCRN Federally Qualified Health Centers Survey at approximately 6-
month timepoint. 
Post-treatment – Client participants will be asked to complete the short 
battery of measures (UCLA Loneliness Scale, MOS Social Support 
Survey, and Horyzons Feedback Survey) at the approximately 12-
month timepoint. There will be an additional follow-up visit to 
complete the brief surveys. Provider &/or PSS participants will be 
asked to participate in a qualitative interview focusing on the perceived 
barriers and facilitators to integrating Horyzons within their clinical 
practice as well as the CPCRN Federally Qualified Health Centers 
Survey at the approximately 12-month timepoint. 
 Evaluation 
Primary outcomes – Identification of barriers and enablers to 
implementing Horyzons to assess each clinic's unique circumstances to 
integrate Horyzons as part of routine clinical care. 
Secondary outcomes – Client engagement with the Horyzons platform 
and attrition in the study to assess Horyzons as part of routine clinical 
care. 
Tertiary outcomes – The UCLA Loneliness Scale and MOS Social 
Support Survey (total score) will be used to assess subjective feelings of 
loneliness and social support. Further, clients’ use of emergency and 
social services to further evaluate Horyzons benefit in clinical outcomes. 
Safety Evaluations 
A safety plan for Horyzons was developed before participants joined 
the Horyzons digital platform by Dr. David Penn and study coordinator 
Elizabeth Fraser. All safety measures were approved by the director of 
each NC FEP clinic. 
Statistical and Analytic 
Plan 
Analyses will primarily be thematic qualitative analysis in nature, along 
with quantitative measure of barriers and enablers. Semi-structured 
interviews will be coded to identify each clinic's unique situation to 
integrate Horyzons as part of a clinical offering within their FEP clinic. 
Secondary analyses will include an examination of client participation 
rates and utilization of the platform across sites and their attrition. We 
will also evaluate changes in mean loneliness and social support across 
12 months. 
Data and Safety 
Management 
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. David Penn, or Licensed Clinical 
Psychologist and research collaborator, Dr. Kelsey Ludwig. Dr. Diana 
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 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 5 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, the SHORE 
program in Wilmington, and AEGIS in Asheville. Each CSC clinic employs a multidisciplinary team of providers and 
PSSs 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 especially 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. 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 aims of this study are to assess barriers and facilitators to the implementation of Horyzons as a part of routine 
clinical care received at first-episode psychosis clinics across North Carolina and to evaluate how best the digital 
intervention can be integrated in treatment. Horyzons is an online platform that integrates: i) peer-to-peer on-line 

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social networking; ii) individually tailored interactive psychosocial interventions; and iii) trained moderation. First 
tested in Australia, this type of intervention has been evaluated for individuals with first episode psychosis (FEP) in 
Australia and abroad, including the US and Canada, and has found to be effective impacting various outcomes. 
 
Of note, a pilot study was completed at the Outreach and Support Intervention Services (OASIS) clinic incorporated 
Horyzons as an adjunct to care rather than part of routine services to assess acceptability and effectiveness as well as 
a follow-up study to further access effectiveness and provider and PSSs’ view of Horyzons as part of clinical care. 
While clients will receive compensation for completion of psychological surveys at 3 timepoints, clients will not be 
incentivized for engagement (or lack thereof) in Horyzons to examine the process by which clients are referred to and 
attrition across 12 months. As such, we seek to evaluate the extent to which Horyzons can be integrated into typical 
treatment at five FEP clinics across North Carolina and their step-down outpatient care clinics (e.g., STEP and 
TIDES). 
 
2 RESEARCH DESIGN AND METHODS 
2.1 OVERVIEW  
Client participants will be given access to Horyzons (which is considered a “non-significant risk” medical device and 
is described below) from their date of enrollment through an intervention period of approximately 12 months. 
Horyzons will be monitored daily (two hours per weekday & one hour per weekend day) by trained peer support 
specialists, master's level clinicians, licensed clinical psychologists, and/or graduate students in the Department of 
Psychology and Neuroscience or Social Work at UNC. To facilitate and monitor engagement, a protocol is in place 
that directs moderators to contact participants via text message and/or email if 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. Licensed 
Clinical Psychologists, Dr. David Penn and/or Dr. Kelsey Ludwig 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 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 
study questionnaires and interviews). 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 
community and other sharing areas of the platform. Research staff at the university and/or providers at the FEP 
clinics in North Carolina will train and supervise all Horyzons peer support specialists, who will also be asked to 
provide feedback through participation in qualitative interviews. 
 
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. 

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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 with individuals experiencing 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/they moderate 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. At the study midpoint (approximately 6-months) both client and provider/PSS participants will be 
asked to complete surveys. Client participants will complete a battery of measures evaluating loneliness, social 
supports, and feedback on the Horyzons platform (UCLA Loneliness Scale, Medical Outcomes Study [MOS] Social 
Support Survey, and Feedback Questionnaire, respectively). Provider and PSS participants will complete the adapted 
CPCRN Federally Qualified Health Centers Survey assessing outer-, inner-, and individual-settings in ability to 
integrate Horyzons. After clients have engaged with the platform for 52 weeks (about 12 months), clients will meet 
with research staff via HIPAA-compliant Zoom to complete the measure battery (UCLA Loneliness Scale, MOS 
Social Support Survey, and Feedback Questionnaire). Additionally at the post-treatment timepoint, provider and PSS 
participants will be asked to participate in feedback about the integration of the Horyzons platform within clinical 
care through qualitative interviews in addition to the CPCRN Federally Qualified Health Centers Survey. Both 
qualitative interviews and quantifiable data about their experience with barriers and enablers to the integration of 
Horyzons within their clinical care. Interviews with providers and PSSs will focus on their perceptions of capability, 
opportunity and motivation to integrate Horyzons, along with individual, provider, inner, and outer settings that 
impacted their ability to implement Horyzons within routine clinical care. 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. 
 
2.2 SUBJECTS 
Up to 70 total study subjects will be recruited from the five FEP clinics in North Carolina (OASIS, Encompass, Eagle, 
SHORE, and AEGIS) and their stepdown outpatient clinics (STEP and TIDES), including up to 50 FEP clients and 
20 FEP providers (clinicians and PSS). All subjects will have a primary diagnosis of schizophrenia spectrum disorder. 
Demographic and clinical information that will be collected as self-report for possible use as covariates includes: 1) 
demographics: age, sex & gender identity, race & ethnicity, 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 primary 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 five FEP clinics in North Carolina (OASIS, 
Encompass, Eagle, SHORE, AEGIS) or FEP clinics stepdown care clinics (STEP and TIDES) 
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 have been actively engaging in psychiatric medication management in the prior month 
7. Clients must have access to the internet through a phone, tablet, or computer 
 

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2.2.2 EXCLUSION CRITERIA  
1. Clients who do not speak English will not be considered for enrollment 
2. Clients 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. Identifying barriers and facilitators of implementing Horyzons at NC FEP clinics through the following: 
• Conducting qualitative interviews following the CFIR framework to identify individual-, inner-, and 
outer-setting climate and implementation of evidence-based practices within each clinic 
• Administration of quantitative measures pre-, mid-, and post-intervention to further assess barriers 
and facilitators experienced by providers and PSSs in the integration and implementation of Horyzons 
2. Evaluation of engagement of the platform and attrition of client participants across 12 months to assess 
acceptability of Horyzons as a routine clinical intervention within NC FEP clinics. 
3. Evaluation of psychological outcomes (loneliness and social support) in addition to use of services (e.g., 
emergency department, hospitalization, outpatient services) to assess potential benefits (e.g., stability in 
symptoms) as a result of engagement with Horyzons. 
 
3.1 OUTCOMES 
Based on previous interviews with providers and peer support specialists, we hypothesize providers and/or PSS will 
report barriers that may be unique to each clinic as each experiences different outer-, inner, and individual-setting 
circumstances. Previous barriers, which will likely be reiterated and further described include time constraints, 
workload, staffing turnover, and perception of the implementation of a new intervention within care. Facilitators are 
also likely to be distinctive to each clinic, including the support of the team lead in the implementation of Horyzons 
and time dedicated to Horyzons within care, perception and desire to incorporate evidence-based interventions into 
clinical treatment to improve client outcomes, and goals and aims of Horyzons aligning with their role.  
 
4 STUDY PROCEDURES 
4.1 SCREENING & BASELINE PROCEDURES 
4.1.1 SCREENING PROCEDURES 
For recruitment of client participants, the research study coordinator will communicate with providers 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, AEGIS, STEP and TIDES 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 and/or website form), the research coordinator 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). 

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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. 
 
For provider and PSS participation, research staff will reach out to the five FEP clinics (OASIS, SHORE, Encompass, 
Eagle, and AEGIS) through the program directors. Due to the long-standing relationship and close working 
partnership of the PI with programs, research staff are connected to program directors. After an explanation of the 
study is given to the program directors, program directors will be asked to discuss the study with their team prior to 
research staff reaching out to each team member individually. Providers and/or PSS will then be contacted by research 
staff to determine if they would like to participate and be screened to determine eligibility. 
 
4.1.2 BASELINE PROCEDURES 
The study coordinator will meet virtually with client participants for approximately 45 minutes to complete all baseline 
measures. Informed consent and HIPAA authorization will be completed first via DocuSign’s electronic consent 
platform, followed by a demographic and characteristic form collecting basic information about sex, age, ancestry, 
education (including parent education levels and zip code), cigarette/alcohol use, and basic history of 
medication/psychosis (including DUP). This will be followed by two psychological measures: the UCLA Loneliness 
Scale and MOS Social Supports Survey. Once the baseline study measures are complete, the study coordinator will 
guide clients through a 10-minute orientation to the Horyzons platform, including creating their personal profile and 
learning the features of the site. Client participants will be paid $20.00 via Visa gift card for their time and completion 
of the visit. 
 
The study coordinator will verbally highlight over the phone the study aims, what will be asked of the provider, the 
timeline of their participation, and that their participation is voluntary for each provider participant at the end of the 
screening. The provider participants will then be sent the consent forms via DocuSign to sign. In the email and at the 
top of the consent form in DocuSign there will be a number to call if they have questions. The language will explicitly 
indicate to call the number prior to consenting and signing the document if they have questions. The provider 
participants will then be sent the baseline surveys (demographics and CPCRN FQHC Survey) to complete on their 
own. Providers and PSS will be compensated $30 for completing the consent and baseline measures.  
 
4.2 INTERVENTION PERIOD PROCEDURES 
4.2.1 MID-TREATMENT PROCEDURES 
Research staff will meet with client participants virtually to complete the measure battery (UCLA Loneliness Scale, 
MOS Social Support Survey and Feedback Survey) for the mid-treatment measures at approximately 6-month mark 
(+/- 4 weeks). Client participants will be compensated $10 via Visa gift cards or Tango e-gift card for the approximate 
30-minute visit. The study coordinator will send the electronic survey to the provider participants for the mid-
treatment measures at the 6-month mark (+/- 4 weeks). Provider and/or PSS participants will complete electronic 
copies of the CPCRN Federally Qualified Health Centers Survey. Provider and/or PSS participants will be paid $20.00 
via Visa gift card or Tango e-gift card for these 40 minutes of their time. 
4.2.2 POST-TREATMENT PROCEDURES 
Research staff will meet virtually with client participants to complete the finally set of aforementioned measure battery 
for the post-treatment visit at approximately 12-month timepoint (+/- 4 weeks). Client participants will be 
compensated $10 via Visa gift cards or Tango e-gift card for the approximately 30-minute visit. There will be an 
additional follow-up survey 3-months post-intervention to complete the brief surveys. Clients will additionally be 
compensated $10 for this completion of this visit. The study coordinator will send the electronic survey to the provider 
participants for the post-treatment measures at the 12-month mark (+/- 4 weeks). Provider and/or PSS participants 

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will complete electronic copies of the CPCRN Federally Qualified Health Centers Survey. After completing the 
electronic measure, the study coordinator will contact the provider participant to determine if they are willing to 
participate in the qualitative interview. If they are willing, the study coordinator will meet with them via 
videoconferencing and lead provider and PSS participants through a semi-structured qualitative interview regarding 
the Horyzons and various barriers and facilitators to its implementation within their clinic. Provider and PSS 
participants will be compensated $20 for completing the post-treatment survey as well as an additional $30/hr 
prorated to the nearest half hour if they complete the qualitative interview. 
4.3 Client Procedures 
Upon completion of the 12-month intervention period, research staff will collect and amalgamate the passive 
engagement information of each participant on the platform to assess acceptability and feasibility of Horyzons as part 
of clinical care. Additionally, client participants’ medical records will be examined for service use (e.g., emergency 
room visits, hospitalizations, outpatient care, etc.) as a result of their mental health. 
 
5 DATA ANALYTIC PLAN 
5.1 PRIMARY OUTCOME MEASURES 
1. Qualitative Summaries of Provider and PSS Participant Feedback in Post-Treatment Interview 
[Time Frame: up to 12 months] 
This qualitative data will be collected post-treatment from providers and PSSs. Individual interviews will 
discuss the utility and usage of Horyzons within their clinical care in addition to barriers and facilitators 
on numerous levels (individual, inner setting, and outer setting) of its implementation within their clinic. 
Feedback from participants will be summarized to include common themes regarding implementation, 
barriers, and enablers within the clinical setting and ideas for future implementation. 
2. Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback 
[Time Frame: up to 12 months] 
This quantitative data will be collected pre-, mid-, and post-intervention from providers and PSSs. 
Feedback forms will prompt participants to answer questions regarding their experience with barriers and 
facilitators in implementing an evidence-based practice (in this case Horyzons) in various settings (outer, 
inner, and individual). The survey will be analyzed regarding changes or lack thereof in the various settings 
and climate.  
5.2 SECONDARY OUTCOME MEASURES 
1. Mean Change in UCLA Loneliness Scale Score [Time Frame: Baseline, Post-treatment, up to 12 
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. 
 
1. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score [Time Frame: 
Baseline, Post-treatment, up to 12 months] 
 

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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. 
 
2. Quantitative Summaries of Participant Experience in Post-Treatment Feedback [Time Frame: up to 12 
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. 
 
5.3 TERTIARY OUTCOME MEASURES 
1. Change in Engagement with the Horyzons Platform and Attrition over time [Time Frame: up to 12 
months] 
 
Changes in engagement with Horyzons will be passively collected for client participants via the platform. 
Data evaluated will include number of logins, number of journeys, tracks, and activities completed, and 
number engagements on the community page. 
 
2.  Change in use of emergency and social services [Time Frame: Pre- and Post-intervention, up to 12 months] 
 
Collection of use of emergency and social services pre-initiation and post-initiation of Horyzons will be assessed to 
determine change in use of such services. 
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 implementation of Horyzons in North Carolina as part of clinical services. 
 
5.5 DATA MANAGEMENT 
We will use the REDCap system to facilitate data entry and management, including informed consent. 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 NVivo program for qualitative analysis. DocuSign’s HIPAA 
compliant informed consent system will be used to obtain informed consent and electronic signature from 
participants. 
 
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. 
 

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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. Additionally, consent forms 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 and/or PSS will be 
instructed via email or phone call before the interview to identify an appropriate location (i.e., private space) if held 
virtually rather than in person. All documents such as consent documents and surveys will be sent to providers and/or 
PSS 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-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, 
research coordinator, 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 wellbeing 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.  
 

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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's ability 
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) 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 (988; 
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 and ability to implement the intervention as part of mental health care at first episode clinics in North 
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Benefits to clients. The proposed study may increase clients’ sense of belonging and social support. Also, if they engage in 
therapeutic pathways within the Horyzons platform, they might develop cognitive behavioral and mindfulness-based 
skills. 
 
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 and PSSs 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 community page). 
 
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). Qualitative interviews 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) will be password protected and stored securely, 
and will only be directly accessible by the research study coordinators, clinicians and peer support specialists, and 
collaborators involved in this project, or PI (Dr. Penn). 
 
As this research program is being implemented in clinical settings, it is possible that FEP clinicians or PSSs 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 will be stored on a secure, 
password-protected server.  
 
Identifiable data will only be shared with the providers and PSSs 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 
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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 providers and PSSs. 
 
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 event (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. 
• 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. 

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8 RECRUITMENT STRATEGY 
Client study subjects will be drawn from the five first episode psychosis clinics in North Carolina (OASIS, Encompass, 
SHORE, Eagle, and AEGIS). 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 40 client participants will be recruited from the five 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 five participating clinics; therefore, we expect approximately 20 providers and/or PSS 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 potential eligibility. Providers and PSSs 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 providers 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 during the protocol (this is to be used as 
comprehension check before consenting). As Horyzons is a fully virtual research study, participants will provide 
electronic consent via DocuSign’s HIPAA compliant electronic consent platform. 
 
 

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10 REFERENCES  
1. Dixon, L. B., Goldman, H. H., Srihari, V. H., & Kane, J. M. (2018). Transforming the treatment of 
schizophrenia in the United States: the RAISE initiative. Annual Review of Clinical Psychology, 14, 237-258. 
2. Nossel, I., Wall, M. M., Scodes, J., Marino, L. A., Zilkha, S., Bello, I., ... & Dixon, L. (2018). Results of a 
coordinated specialty care program for early psychosis and predictors of outcomes. Psychiatric 
Services, 69(8), 863-870. 
3. Singh, S. P. (2010). Early intervention in psychosis. The British Journal of Psychiatry, 196(5), 343-345. 
4. Alvarez-Jimenez, M., Parker, A. G., Hetrick, S. E., McGorry, P. D., & Gleeson, J. F. (2011). Preventing 
the second episode: a systematic review and meta-analysis of psychosocial and pharmacological trials in 
first-episode psychosis. Schizophrenia Bulletin, 37(3), 619-630. 
5. Gafoor, R., Nitsch, D., McCrone, P., Craig, T. K., Garety, P. A., Power, P., & McGuire, P. (2010). 
Effect of early intervention on 5-year outcome in non-affective psychosis. The British journal of 
psychiatry, 196(5), 372-376. 
6. Norman, R. M., Manchanda, R., Malla, A. K., Windell, D., Harricharan, R., & Northcott, S. (2011). 
Symptom and functional outcomes for a 5 year early intervention program for psychoses. Schizophrenia 
research, 129(2-3), 111-115. 
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 in first episode 
psychosis. Schizophrenia research, 143(1), 143-149.