Horyzons: Implementation in Clinical Practice

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Unspecified Schizophrenia Spectrum and Other Psychotic Disorder; Schizophreniform Disorders
• Interventions: Device: Horyzons USA

• Registration Number: NCT04673851
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-01-19
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-06
• Results First Submitted: 2024-06-21
• Results First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Results First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FEP Clients	Horyzons USA	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.
FEP Clinicians	Horyzons USA	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in UCLA Loneliness Scale 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)	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).
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - 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)	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).

Secondary Outcome Measures

Name	Time	Method
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)	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).
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)	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).

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States