Clinical trial NCT06002958: Horyzons: Implementation and Integration in Clinical Practice
Official title: Horyzons: Implementation and Integration in Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophreniform Disorders
Schizoaffective Disorder
Unspecified or Other Psychotic Disorders
Keywords: Digital Intervention
Social Media
Virtual Therapeutic Content
First Episode Psychosis
Implementation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Department of Health and Human Services
First posted: 2023-08-21
Enrollment: 55
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: The primary aim of this trial is evaluating the barriers and enablers of implementing a digital intervention with both therapeutic content and social networking, Horyzons, as part of clinical care in first episode psychosis (FEP) clinics in North Carolina. Providers (clinicians and peers support specialists) will be recruited from FEP clinics to assess Horyzons implementation and integration within clinical care at three time points (baseline, 6 months, and 12 months). Further, individuals experiencing FEP between the ages of 16 and 35 receiving services from the FEP clinics will be recruited to engage with the platform over the course of 12 months. Due to the nature of the digital intervention being implemented across the state of North Carolina, all research visits will be conducted remotely via videoconferencing.

Detailed description: Purpose: The primary objective is to assess the barriers and facilitators of integrating Horyzons, an evidence-based digital intervention, in outpatient mental health clinics in North Carolina that provide care to individuals with schizophrenia spectrum and other unspecified psychotic disorders. The primary aim is to evaluate and identify the unique barriers and facilitators in implementing Horyzons at each first episode psychosis (FEP) clinic as part of standard care and distinct implementation strategies. The secondary and tertiary aims are to evaluate client engagement with Horyzons and attrition as part of clinical care and assess the change in clients' psychological measures across in addition to their use of state-funded services (e.g., emergency department and social services) across the 12-month intervention.

Participants: To assess the first aim, the investigators will recruit 20 clinicians and/or peer specialists from the FEP clinics. To assess the first and second aim, the investigators will recruit 50 individuals with FEP (i.e., first episode of a schizophrenia spectrum and other unspecified psychotic disorders).

Procedures (methods): Service provider participants will be recruited over a 4-6 week period at their respective clinics. They will be asked to complete an adapted measure, the Cancer Prevention and Control Research Network (CPCRN) Federally Qualified Health Center (FQHC) Survey, assessing clinical readiness, leadership, acceptance, adoption, and perspective on evidence-based practices. Service providers will then participate in implementing and integrating Horyzons within clinical practice including preferred implementation strategy that is distinct for each clinic (e.g., Horyzons training, access to the platform by clinicians, ongoing technical support, attendance and update at monthly team meetings, etc.). Service providers will meet with research staff at approximately the 6-month timepoint (+/- 4 weeks) to complete the CPCRN FQHC Survey then upon completion of the effectiveness trial with clients, service providers will complete this measure once again in addition to participating in a qualitative interview based on the Consolidated Framework for Implementation Research (CFIR) around their experience with integrating the platform and identification of barriers and facilitators to Horyzons' implementation. Service providers will be compensated for the completion feedback, including the questionnaire and qualitative interviews.

Client participants will be recruited over a 16- to 20-week period at their respective clinic. Participants will participate in a baseline visit to provide informed consent and complete a brief battery of measures (Demographics and Characteristics, University of California, Los Angeles (UCLA) Loneliness Scale, MOS Social Supports Survey). Participants will then meet with a research assistant, peer support specialist, or clinician to be given guidance and instruction for using the site (i.e., Horyzons onboarding). Clients will then engage in the platform, where site usage information as well as experience will be collected from participants through the Horyzons platform. Site usage (e.g., number of posts/comments made on the online platform, number and type of 'Journeys' or 'Tracks', self-guided therapeutic content, completed during time on the platform) will automatically be collected via the platform. Participants will have access and engage in this platform for approximately 12 months, depending on when recruited into trial. During this 12 month engagement period with the platform, client participants will meet with research staff at their midway point to complete the brief battery of measures assessing loneliness and social support and feedback on Horyzons. Upon completion of their engagement with the platform, client participants will additionally participate two additional research visits to complete the battery of measures at 12-months and at a 3-month follow-up. research visits to complete the battery of measures at 12-months and at a 3-month follow-up. As Horyzons involves therapeutic content and is designed to improve psychological outcomes, such as loneliness and social support, this platform is considered part of clinical care provided to individuals by their respective clinic. For this reason, participants will not be compensated for their usage and engagement with the platform, but rather, they will receive compensation for completion of assessment batteries at baseline, midway, final, and follow-up research study visits.

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 with relevant clinical/research experience with individuals with psychosis. Drs. David Penn and Kelsey Ludwig, who are clinical psychologists, lead weekly supervision calls to ensure appropriate care and support of clients involved in the trial, to discuss case conceptualization and suggestions for engaging clients in the platform.

Eligibility criteria: CLIENT PARTICIPANTS

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 five FEP clinics in North Carolina (OASIS, Encompass, Eagle, SHORE, or AEGIS) or one of their stepdown outpatient clinics (STEP and TIDES)
* Client not having any active thoughts of harming self in the month prior to enrollment
* Clients must not have been hospitalized for psychiatric reasons in the three months before enrollment
* Clients must actively be engaging with medication management through their clinic
* 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 client with legal guardians where one or both the individual and legal guardian do not provide consent for the individual to participate

PROVIDER PARTICIPANTS

Inclusion Criteria:

* Provider \&/or PSS must be 18 years or older
* Provider \&/or PSS must be currently serving clients within their FEP clinic
* Provider \&/or PSS must be able to speak and read English

Exclusion Criteria:

* Provider \&/or PSS under the age of 18
* Provider \&/or PSS not currently serving clients in their FEP clinic
* Provider \&/or PSS not able to speak or understand English

Primary outcomes:
measure: Qualitative Summaries of Provider and Peer support specialists (PSSs) Participant Feedback in Post-Treatment Interview
timeFrame: Up to 9 months
measure: Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
timeFrame: Up to 9 months
Secondary outcomes:
measure: Change in Engagement with the Horyzons Platform and Attrition over time
timeFrame: Baseline, up to Month 12
measure: Change in use of emergency and social services
timeFrame: Baseline, Month 12 following intervention completion, a total of up to 24 months
Other outcomes:
measure: Mean Change in UCLA Loneliness Scale Score
timeFrame: Up to 12 months
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score
timeFrame: Up to 12 months
measure: Quantitative Summaries of Participant Experience in Post-Treatment Feedback
timeFrame: Up to 12 months
measure: Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score
timeFrame: Up to 12 months
measure: Mean Change in Twente Engagement with E-health Technologies Scale - Total Score
timeFrame: Up to 12 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: Univeristy of North Carolina, School of Medicine
name: Diana Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Felice Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References: