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Digital Intervention for Psychosis
N/A
Recruiting
Led By David Penn, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 12 following intervention completion, a total of up to 24 months
Awards & highlights
Study Summary
This trial is studying how a digital intervention (with therapeutic content & social networking) can help people with first episode psychosis in NC. Recruiting providers and those experiencing FEP to assess the platform over 12 months. Research visits done remotely.
Who is the study for?
This trial is for young people aged 16-35 with first episode psychosis, such as schizophrenia or related disorders, who are getting care at certain North Carolina clinics. They must have internet access and be stable on medications without recent hospitalization or current severe self-harm thoughts.Check my eligibility
What is being tested?
The study tests 'Horyzons', a digital platform combining therapy and social networking, to see how well it can be used in clinical practice for treating first episode psychosis. Participants will use Horyzons for a year with the study tracking its integration into their treatment remotely.See study design
What are the potential side effects?
Since 'Horyzons' is a digital intervention rather than a medication, traditional side effects like those seen with drugs aren't expected. However, users may experience discomfort or stress from using the technology or engaging with its content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 12 following intervention completion, a total of up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12 following intervention completion, a total of up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Qualitative Summaries of Provider and Peer support specialists (PSSs) Participant Feedback in Post-Treatment Interview
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Secondary outcome measures
Change in Engagement with the Horyzons Platform and Attrition over time
Change in use of emergency and social services
Other outcome measures
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score
Mean Change in UCLA Loneliness Scale Score
Quantitative Summaries of Participant Experience in Post-Treatment Feedback
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FEP ClientsExperimental Treatment1 Intervention
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 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, and 3 month follow-up.
Group II: FEP ProvidersActive Control1 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 three time points (baseline, 6 months, and 12 months) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Horyzons USA
2021
N/A
~90
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,972 Total Patients Enrolled
26 Trials studying Schizophrenia
2,589 Patients Enrolled for Schizophrenia
North Carolina Department of Health and Human ServicesOTHER_GOV
13 Previous Clinical Trials
131,895 Total Patients Enrolled
1 Trials studying Schizophrenia
89 Patients Enrolled for Schizophrenia
David Penn, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
166 Total Patients Enrolled
2 Trials studying Schizophrenia
106 Patients Enrolled for Schizophrenia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who can sign up to participate in this medical experiment?
"Eligibility for this study requires a diagnosis of schizophrenia and being between the ages of 16 - 35. Approximately 70 individuals are needed to complete the trial."
Answered by AI
Does this clinical trial encompass individuals aged over 50 years?
"This research endeavour is recruiting individuals aged between 16 and 35 years old."
Answered by AI
Is this experimental trial still open for enrolment?
"The clinical trial portal shows that this particular study is not currently recruiting. It was initially posted on September 5th 2023 and last modified August 14th 2023, suggesting that it has completed its recruitment process for now. However, there are 460 other trials actively looking for volunteers right now."
Answered by AI
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