Horyzons: Implementation and Integration in Clinical Practice

NCT06002958 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-18

Study results available
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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

Interventions

DEVICE

Horyzons USA

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.

Sponsors & Collaborators

  • North Carolina Department of Health and Human Services

    collaborator OTHER_GOV
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • David Penn, PhD · University of North Carolina, Chapel Hill

  • Diana Perkins, MD, MPH · Univeristy of North Carolina, School of Medicine

  • Felice Reddy, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002958 on ClinicalTrials.gov