Horyzons: Implementation in Clinical Practice

NCT04673851 | Completed Results FDA Device

• 1 other identifier: 19-1709
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Unspecified Schizophrenia Spectrum and Other Psychotic Disorder

Keywords

Social Media; Virtual Therapeutic Content; First Episode Psychosis; Virtual Therapy

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

• 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).

  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)

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

  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)

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

  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)

Other Outcomes (24)

• Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts)

  Cohort 1: Mid-treatment (between Month 1-2), Post-treatment (up to 3 months); Cohort 2: 1.5 months (between Month 1-2), Mid-treatment (between Month 2-4), 4.5 months (between Month 4-5), Post-treatment (up to 6 months)

• Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts)

  Cohort 1: Mid-treatment (between Month 1-2), Post-treatment (up to 3 months); Cohort 2: 1.5 months (between Month 1-2), Mid-treatment (between Month 2-4), 4.5 months (between Month 4-5), Post-treatment (up to 6 months)

• Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts)

  Cohort 1: Mid-treatment (between Month 1-2), Post-treatment (up to 3 months); Cohort 2: 1.5 months (between Month 1-2), Mid-treatment (between Month 2-4), 4.5 months (between Month 4-5), Post-treatment (up to 6 months)

Study Arms (2)

FEP Clients

EXPERIMENTAL

Participants 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.

Device: Horyzons USA

FEP Clinicians

OTHER

Providers (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.

Device: Horyzons USA

Interventions

Horyzons USA DEVICE

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.

FEP Clients; FEP Clinicians

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 37252256 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Bryan Stiles, MA
• Organization: University of North Carolina at Chapel Hill

stilesb@unc.edu

919-590-5811

Study Officials

• David Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Diana Perkins, MD, MPH

  University of North Carolina, Chapel Hill - School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: January 19, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 to 36 months following publication
• Access Criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

Locations

US (1)