Horyzons: Implementation in Clinical Practice

Study Overview
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Brief Summary
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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 18 and 35 who are enrolled at one of the 4 FEP 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
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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 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.

Official Title
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Horyzons: Implementation in Clinical Practice

Conditions
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Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Unspecified Schizophrenia Spectrum and Other Psychotic Disorder

Intervention / Treatment
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* Device: Horyzons USA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clients must be between the ages of 18 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) 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 Exclusion Criteria: Clients who do not speak English will not be considered for enrollment Clients with legal guardians (LARs) will not be considered for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEP Clients<br>Approximately 90 first episode psychosis (FEP) clients recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) 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<br>* 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.<br>|
| Other: FEP Clinicians<br>Approximately 40 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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 4 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). | up to 6 months | 
| 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). | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Media, Virtual Therapeutic Content, First Episode Psychosis, Virtual Therapy