N/A
N=85
Horyzons: Implementation in Clinical Practice
Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorders · Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04673851 ↗Enrolled (actual)
85
Serious AEs
1.6%
Results posted
Aug 2024
Primary outcome: Primary: Mean Change in UCLA Loneliness Scale Score (Both Cohorts) — 42.96; 45.08; 41.95; 42.47 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Horyzons USA (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in UCLA Loneliness Scale Score (Both Cohorts) |
42.96; 45.08; 41.95; 42.47; 39.70; 40.78 | — |
| PRIMARY Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts) |
77.28; 73.24; 76.19; 74.90; 79.45; 76.59 | — |
| SECONDARY Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts) |
26.24; 27.54; 26.90; 28.90; 23.85; 26.85 | — |
| SECONDARY Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts) |
83.80; 78.38; 84.57; 81.87; 88.20; 86.41 | — |
Summary
A clinical trial investigating 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. Clients between the ages of 16 and 35 who are enrolled at one of the 4 FEP clinics or 3 UNC-affiliated STEP Clinics in North Carolina will be considered for enrollment in the trial. Cohort 1 participants will have access to the platform for 3 months and cohort 2 participants will have access to the platform for 6 months. All interventions and assessments will be completed virtually/remotely due to the global pandemic.
Eligibility Criteria
Inclusion Criteria
- 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 four FEP clinics in North Carolina (OASIS, Encompass, Eagle, or SHORE) or UNC-affiliated STEP clinics (Carr Mill Mall, Vilcom Center, Main Wake Clinic)
- Clients must not have had thoughts of harming themselves in the month before enrollment
- Clients must not have been hospitalized for psychiatric reasons in the three months before enrollment
- Clients must not have had a psychiatric medication change in the month before enrollment
- Clients must have access to the internet through a phone, tablet, or computer
Exclusion Criteria
- Clients who do not speak English will not be considered for enrollment
- Adult clients (18+ years) with legal guardians (LARs) will not be considered for the study
Data sourced from ClinicalTrials.gov (NCT04673851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.