← Back to Search

Digital Intervention for Psychosis

N/A

Recruiting

Led By Diana Perkins, MD, MPH

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12 following intervention completion, a total of up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in Engagement with the Horyzons Platform and Attrition over time

Change in use of emergency and social services

Other study objectives

Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score

Mean Change in Twente Engagement with E-health Technologies Scale - Total Score

Mean Change in UCLA Loneliness Scale Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (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.

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 two time points (baseline, 9 months) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at 9 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Horyzons USA

2021

N/A

~90

Do I qualify?Apply below to find out