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SchizophreniaNCT04673851

Horyzons: Implementation in Clinical Practice

A study testing Horyzons USA in people with Schizophrenia and Schizoaffective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years
What is being tested?
Horyzons USA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
19 Jan 2021to 31 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the detailed description

Purpose: Our primary objective is to examine the feasibility and acceptability of implementing Horyzons as a part of care received at first-episode psychosis clinics across North Carolina. Our primary aim is to understand how to implement a novel treatment approach as part of routine clinical practice with guidance, assistance, and feedback from service providers (e.g., clinicians, peer support specialists) embedded within the clinic. Our second aim is to assess the extent to which clients engage with the platform (i.e., site usage information) and their thoughts and opinions of Horyzons (i.e., feedback and suggestions). Our third aim is to assess change in psychological measures across the three-month (cohort 1) or six-month (cohort 2) study period.

Participants:

Cohort 1:

30 individuals with first episode psychosis (FEP) 20 clinicians and/or peer support specialists from the FEP clinics

Cohort 2:

60 individuals with FEP 20 clinicians and/or peer support specialists from the FEP clinics

Procedures (methods): FEP participants will be recruited over a 16-week period at their respective first episode clinic. Site usage information as well as feedback about their experience will be collected from participants through the Horyzons platform. Site usage information (e.g., number of posts/comments made on the site, the number and types of 'Journeys' or 'Tracks' (therapeutic content) completed by participants, etc.) will be collected automatically through the Horyzons platform. This trial will last three months for cohort 1 and six months for cohort 2. Before being given access to Horyzons, a research assistant, peer support specialist, or clinician will provide instructions and guidance for using the site (i.e., Horyzons induction). Feedback will be collected from participants at the end of the active study period.

Service providers (i.e., clinicians and/or peer support specialists) will be asked to provide feedback about their perceptions of their clients' responses to engaging in Horyzons for the 3-month (cohort 1) or the 6-month (cohort 2) period. Clinicians and peer support specialists will also be asked about their experience integrating the psychosocial intervention in the clinic. Items will include challenges to clinic-wide implementation as well as their feedback to overcome/reduce the impact of these barriers if Horyzons were to be provided as part of routine clinical care in the future. Clinicians and peer support specialists will be interviewed in 1-2 focus groups (depending on schedule and availability) for which these individuals will be compensated.

As Horyzons involves therapeutic content and is designed to improve psychological outcomes such as loneliness and social support, this service is considered part of the clinical care provided to individuals by their respective FEP clinic. As such, participants will not be compensated for their involvement in the platform. Site usage information will be collected automatically through the Horyzons site. However, clients will be compensated for providing feedback about their experience with Horyzons as well as for completing the assessment portion of the study onboarding process.

Finally, Horyzons will be monitored daily (two hours per weekday and one hour per weekend day) by trained peer support specialists, master's level clinicians, and/or graduate students in the Department of Psychology and Neuroscience at UNC. The principal investigator, David Penn, will lead weekly supervision calls to ensure appropriate care and support of clients involved in this project, to discuss case conceptualization and suggestions for engaging clients in the platform, as well as to monitor any potential safety concerns. All clinically-relevant information will be shared with the first episode clinicians involved in participants' mental health care.

Being tested
Horyzons USA
Keywords
Social Media, Virtual Therapeutic Content, First Episode Psychosis, Virtual Therapy
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Horyzons USADevice

    Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.

Study groups in NCT04673851
Study groupRoleWhat they receive
FEP ClientsExperimentalParticipants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) or UNC-affiliated STEP Clinics (Carr Mill Mall, Vilcom Center, Main Wake Clinic) will participate in the online platform Horyzons for 3 months (cohort 1) or 6 months (cohort 2) as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study.
Receives: Device: Horyzons USA
FEP CliniciansOtherProviders (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study.
Receives: Device: Horyzons USA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in UCLA Loneliness Scale Score (Both Cohorts)

    The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit. The UCLA Loneliness Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

    Measured: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

  2. Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts)

    The MOS Social Support Survey is a 19 item scale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social support (more perceived social support). The MOS Social Support Survey is a part of the PhenX Toolkit. The MOS Social Support Survey is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

    Measured: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

Secondary outcomes (2)

  1. Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts)

    The Social Interaction Anxiety Scale (SIAS) is a 20 item scale. Answers are on a 5-point scale starting at 0 with options "none at all", "slightly", "moderately", "very", and "extremely". Possible scores range from 0 to 80. Higher scores reflect higher levels of social anxiety. Scoring a 43 or higher may indicate a diagnosis of social anxiety, and scores between 34 and 42 may indicate social phobia(s). The SIAS is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

    Measured: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

  2. Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts)

    The Psychological Wellbeing Scale (Short Form) is an 18 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 18 to 108. Higher scores reflect higher levels of psychological wellbeing. The Psychological Wellbeing Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

    Measured: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start19 Jan 2021
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673851
Sponsor's protocol ID
19-1709
Status last verified
Jun 2024
First submitted
11 Dec 2020
Last updated
15 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Pokowitz EL, Stiles BJ, Thomas R, Bullard K, Ludwig KA, Gleeson JF, Alvarez-Jimenez M, Perkins DO, Penn DL. User experiences of an American-adapted moderated online social media platform for first-episode psychosis: Qualitative analysis. Digit Health. 2023 May 22;9:20552076231176700. doi: 10.1177/20552076231176700. eCollection 2023 Jan-Dec.

    PubMed 37252256

Questions about this trial

What is this clinical trial studying?

A study testing Horyzons USA in people with Schizophrenia and Schizoaffective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in UCLA Loneliness Scale Score (Both Cohorts) (time frame: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.

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Horyzons: Implementation in Clinical Practice | AzTrials