Horyzons: Implementation and Integration in Clinical Practice

NCT06002958 | Terminated Results FDA Device

• 1 other identifier: 23-0672
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this trial is evaluating the barriers and enablers of implementing a digital intervention with both therapeutic content and social networking, Horyzons, as part of clinical care in first episode psychosis (FEP) clinics in North Carolina. Providers (clinicians and peers support specialists) will be recruited from FEP clinics to assess Horyzons implementation and integration within clinical care at three time points (baseline, 6 months, and 12 months). Further, individuals experiencing FEP between the ages of 16 and 35 receiving services from the FEP clinics will be recruited to engage with the platform over the course of 12 months. Due to the nature of the digital intervention being implemented across the state of North Carolina, all research visits will be conducted remotely via videoconferencing.

Conditions

Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Unspecified or Other Psychotic Disorders

Keywords

Digital Intervention; Social Media; Virtual Therapeutic Content; First Episode Psychosis; Implementation

Outcome Measures

Primary Outcomes (2)

• Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview

  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 will be analyzed using grounded theory and summarized to include common themes regarding implementation, barriers, and enablers within the clinical setting and ideas for future implementation.

  Up to 9 months

• Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback

  Quantitative data will be collected from providers and peer support specialists (PSSs) at baseline and post-treatment using a structured survey informed by the Consolidated Framework for Implementation Research (CFIR). The survey consists of Likert-style items rated from 1 = "strongly disagree" to 5 = "strongly agree" that capture perceived barriers and facilitators to implementing Horyzons in clinical practice (e.g., "People in our clinic actively seek new ways to improve how we do things"). Items correspond to four subscales based on the CFIR framework: inner setting, outer setting, individual, and process. Subscale scores are calculated by averaging the items within each domain, after reverse scoring when appropriate. Each subscale ranges from 1 to 5, with higher scores indicating more positive perceptions of implementation support for Horyzons (i.e., better outcomes). Descriptive statistics (mean and standard deviation) are reported for each subscale.

  Up to 9 months

Secondary Outcomes (3)

• Mean Change in UCLA Loneliness Scale Score

  Up to 9 months

• Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score

  Up to 9 months

• Quantitative Summaries of Participant Experience in Post-Treatment Feedback

  Up to 9 months

Other Outcomes (2)

• Change in Use of Emergency and Social Services

  Baseline, up to Month 9

• Change in Engagement With the Horyzons Platform and Attrition Over Time

  Baseline, up to Month 9

Study Arms (2)

FEP Providers

NO INTERVENTION

Approximately 20 FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, 9 months) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at 9 months.

FEP Clients

EXPERIMENTAL

Approximately 50 individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, 6-months, 12 months for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.

Device: Horyzons USA

Interventions

Horyzons USA DEVICE

Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.

FEP Clients

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clients must be between the ages of 16 and 35
• Clients must have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or Unspecified Schizophrenia Spectrum or Other Psychotic disorder
• 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)
• Client not having any active thoughts of harming self in the month prior to enrollment
• Clients must not have been hospitalized for psychiatric reasons in the three months before enrollment
• Clients must actively be engaging with medication management through their clinic
• Clients must have access to the internet through a phone, tablet, or computer

You may not qualify if:

• Clients who do not speak English will not be considered for enrollment
• Adult client with legal guardians where one or both the individual and legal guardian do not provide consent for the individual to participate
• PROVIDER PARTICIPANTS
• Provider \&/or PSS must be 18 years or older
• Provider \&/or PSS must be currently serving clients within their FEP clinic
• Provider \&/or PSS must be able to speak and read English
• Provider \&/or PSS under the age of 18
• Provider \&/or PSS not currently serving clients in their FEP clinic
• Provider \&/or PSS not able to speak or understand English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Kelsey Ludwig, PhD
• Organization: University of North Carolina at Chapel Hill

kelsey_ludwig@med.unc.edu

(919) 962-1401

Study Officials

• David Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Diana Perkins, MD, MPH

  Univeristy of North Carolina, School of Medicine

  PRINCIPAL INVESTIGATOR

• Felice Reddy, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 8, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

Locations

US (1)