Clinical trial NCT04673851: Horyzons: Implementation in Clinical Practice
Official title: Horyzons: Implementation in Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords: Social Media
Virtual Therapeutic Content
First Episode Psychosis
Virtual Therapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Department of Health and Human Services
First posted: 2020-12-17
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Mean Change in UCLA Loneliness Scale Score (Both Cohorts)
timeFrame: 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)
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts)
timeFrame: 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:
measure: Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts)
timeFrame: 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)
measure: Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts)
timeFrame: 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:
measure: Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts)
timeFrame: 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)
measure: Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts)
timeFrame: 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)
measure: Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts)
timeFrame: 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)
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational Support Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social Interaction Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score (Both Cohorts)
timeFrame: up to 6 months
measure: Qualitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
timeFrame: up to 6 months
measure: Quantitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
timeFrame: up to 6 months
measure: Mean Change in Questionnaire About the Process of Recovery - Total Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Modified Colorado Symptom Index - Total Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Social Anxiety Scale for Social Media Users - Total Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Social Anxiety Scale for Social Media Users - Shared Content Anxiety Subscale Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Social Anxiety Scale for Social Media Users - Privacy Concern Anxiety Subscale Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Social Anxiety Scale for Social Media Users - Interaction Anxiety Subscale Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Social Anxiety Scale for Social Media Users - Self-Evaluation Anxiety Subscale Score (Cohort 2 Only)
timeFrame: up to 6 months
measure: Mean Change in Perceived Autonomy Support Scale - Total Score (Both Cohorts)
timeFrame: up to 20 weeks
measure: Mean Change in Twente Engagement With E-health Technologies Scale - Total Score (Cohort 2 Only)
timeFrame: up to 6 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David Penn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill - School of Medicine
name: Diana Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: