Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorders, Unspecified or Other Psychotic Disorders
Conditions
Keywords
Digital Intervention, Social Media, Virtual Therapeutic Content, First Episode Psychosis, Implementation
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.
Interventions
DEVICEHoryzons USA
Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Sponsors
North Carolina Department of Health and Human Services
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Up to 9 months | This qualitative data will be collected post-treatment from providers and PSSs. Individual interviews will discuss the utility and usage of Horyzons within their clinical care in addition to barriers and facilitators on numerous levels (individual, inner setting, and outer setting) of its implementation within their clinic. Feedback will be analyzed using grounded theory and summarized to include common themes regarding implementation, barriers, and enablers within the clinical setting and ideas for future implementation. |
| Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Up to 9 months | Quantitative data will be collected from providers and peer support specialists (PSSs) at baseline and post-treatment using a structured survey informed by the Consolidated Framework for Implementation Research (CFIR). The survey consists of Likert-style items rated from 1 = strongly disagree to 5 = strongly agree that capture perceived barriers and facilitators to implementing Horyzons in clinical practice (e.g., People in our clinic actively seek new ways to improve how we do things). Items correspond to four subscales based on the CFIR framework: inner setting, outer setting, individual, and process. Subscale scores are calculated by averaging the items within each domain, after reverse scoring when appropriate. Each subscale ranges from 1 to 5, with higher scores indicating more positive perceptions of implementation support for Horyzons (i.e., better outcomes). Descriptive statistics (mean and standard deviation) are reported for each subscale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Summaries of Participant Experience in Post-Treatment Feedback | Up to 9 months | This quantitative data will be collected post-treatment from clients. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with total scores ranging from 11-55 and higher scores reflecting a more positive experience. |
| Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score | Up to 9 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 mean change from baseline to mid-treatment and baseline to post-treatment will be averaged to get the overall mean for each timepoint. The MOS Social Support Survey is a part of the PhenX Toolkit. |
| Mean Change in UCLA Loneliness Scale Score | Up to 9 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Use of Emergency and Social Services | Baseline, up to Month 9 | Collection of use of emergency and social services pre-initiation and post-initiation of Horyzons will be assessed to determine change in use of such services. |
| Change in Engagement With the Horyzons Platform and Attrition Over Time | Baseline, up to Month 9 | Changes in engagement with Horyzons will be passively collected for client participants via the platform. Data evaluated will include number of logins, number of journeys, tracks, and activities completed, and number engagements on the community page. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FEP Providers FEP providers (clinicians and peer support specialists) affiliated with first episode psychosis (FEP) clinics in North Carolina (OASIS, SHORE, Encompass, Eagle, AEGIS) will be recruited to share their perspectives of barriers and facilitators in implementing and integrating a digital intervention in clinical practice. They will be asked to complete a survey examining their perspective and beliefs at two time points (baseline, post-treatment) as well as a qualitative interview based on the Consolidated Framework for Implementation Science at the end of the trial. | 20 |
| FEP Clients Individuals experiencing FEP and receiving services from FEP clinics (OASIS, SHORE, Encompass, Eagle, AEGIS) or their step down care clinics (STEP and TIDES) will be recruited to participate in a digital platform, Horyzons, for 12 months (for individuals enrolled at the initial opening of the platform; at a minimum 3 months of engagement) as part of their clinical care. Participants will have access to and encouraged to use the therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a small battery of measures at baseline, mid-treatment, post-treatment for individuals enrolled at the initiation of the study, while those enrolled later due to rolling recruitment may experience less assessment visits due to closing of the platform at the end of August 2024.
Horyzons USA: Client participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes therapeutic content that is tailored to each individual and their current needs and experiences, including social anxiety, generalized anxiety, mood, and social functioning, and distress intolerance. Further, the platform includes a moderated social media function, where individuals and peer support specialists can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians. | 32 |
| Total | 52 |
Baseline characteristics
| Characteristic | FEP Providers | Total | FEP Clients |
|---|---|---|---|
| Age, Continuous | 37.75 years STANDARD_DEVIATION 11 | 29.08 years STANDARD_DEVIATION 10.25 | 23.66 years STANDARD_DEVIATION 4.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 49 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 18 Participants | 33 Participants | 15 Participants |
| Region of Enrollment United States | 20 Participants | 52 Participants | 32 Participants |
| Sex/Gender, Customized Female | 14 Participants | 22 Participants | 8 Participants |
| Sex/Gender, Customized Male | 4 Participants | 28 Participants | 24 Participants |
| Sex/Gender, Customized Non-Binary | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 32 |
| other Total, other adverse events | 0 / 20 | 0 / 32 |
| serious Total, serious adverse events | 0 / 20 | 1 / 32 |
Outcome results
Primary
Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview
This qualitative data will be collected post-treatment from providers and PSSs. Individual interviews will discuss the utility and usage of Horyzons within their clinical care in addition to barriers and facilitators on numerous levels (individual, inner setting, and outer setting) of its implementation within their clinic. Feedback will be analyzed using grounded theory and summarized to include common themes regarding implementation, barriers, and enablers within the clinical setting and ideas for future implementation.
Time frame: Up to 9 months
Population: This measure only applied to FEP Providers; therefore, data were not collected for FEP Clients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Lacked team integration; often viewed peer support and/or Horyzons as 'separate' | 9 Participants |
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Viewed Horyzons as a way to combat loneliness and a safe space to socially engage with peers | 12 Participants |
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Flexible/accessible resource that can be used anywhere and anytime | 10 Participants |
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Therapy content that appealed to clients (e.g., psychoed and mindfulness exercises) | 10 Participants |
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Platform lacks a true mobile app experience with notifications and updated design | 7 Participants |
| FEP Providers | Qualitative Summaries of Provider and Peer Support Specialists (PSSs) Participant Feedback in Post-Treatment Interview | Staff turnover and significant demands on clinicians' time made prioritizing Horyzons challenging | 10 Participants |
Primary
Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback
Quantitative data will be collected from providers and peer support specialists (PSSs) at baseline and post-treatment using a structured survey informed by the Consolidated Framework for Implementation Research (CFIR). The survey consists of Likert-style items rated from 1 = strongly disagree to 5 = strongly agree that capture perceived barriers and facilitators to implementing Horyzons in clinical practice (e.g., People in our clinic actively seek new ways to improve how we do things). Items correspond to four subscales based on the CFIR framework: inner setting, outer setting, individual, and process. Subscale scores are calculated by averaging the items within each domain, after reverse scoring when appropriate. Each subscale ranges from 1 to 5, with higher scores indicating more positive perceptions of implementation support for Horyzons (i.e., better outcomes). Descriptive statistics (mean and standard deviation) are reported for each subscale.
Time frame: Up to 9 months
Population: This measure only applied to FEP Providers; therefore, data were not collected for FEP Clients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Inner (baseline) | 3.73 score on a scale | Standard Deviation 0.43 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Inner (post-treatment) | 3.62 score on a scale | Standard Deviation 0.19 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Outer (baseline) | 3.83 score on a scale | Standard Deviation 0.7 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Outer (post-treatment) | 3.84 score on a scale | Standard Deviation 0.54 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Individual (baseline) | 4.21 score on a scale | Standard Deviation 0.48 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Individual (post-treatment) | 4.03 score on a scale | Standard Deviation 0.48 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Process (baseline) | 3.77 score on a scale | Standard Deviation 0.62 |
| FEP Providers | Quantitative Summaries of Provider and PSS Participant Experience in Post-Treatment Feedback | Process (post-treatment) | 3.78 score on a scale | Standard Deviation 0.49 |
95% CI: [-0.815, 0.255]
95% CI: [-0.503, 0.545]
95% CI: [-0.85, 0.225]
95% CI: [-0.85, 0.534]
Secondary
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score
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 mean change from baseline to mid-treatment and baseline to post-treatment will be averaged to get the overall mean for each timepoint. The MOS Social Support Survey is a part of the PhenX Toolkit.
Time frame: Up to 9 months
Population: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FEP Clients | Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score | Baseline to Mid-treatment | -0.005 score on a scale | Standard Deviation 11.66 |
| FEP Clients | Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score | Baseline to Post-treatment | 0.155 score on a scale | Standard Deviation 11.66 |
Secondary
Mean Change in UCLA Loneliness Scale Score
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.
Time frame: Up to 9 months
Population: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FEP Clients | Mean Change in UCLA Loneliness Scale Score | Baseline to Mid-treatment | -0.101 score on a scale | Standard Deviation 9.61 |
| FEP Clients | Mean Change in UCLA Loneliness Scale Score | Baseline to Post-treatment | -0.182 score on a scale | Standard Deviation 9.61 |
Secondary
Quantitative Summaries of Participant Experience in Post-Treatment Feedback
This quantitative data will be collected post-treatment from clients. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with total scores ranging from 11-55 and higher scores reflecting a more positive experience.
Time frame: Up to 9 months
Population: This measure only applied to FEP Clients; therefore, data were not collected for FEP Providers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FEP Clients | Quantitative Summaries of Participant Experience in Post-Treatment Feedback | 41.56 score on a scale | Standard Deviation 7.5 |
Other Pre-specified
Change in Engagement With the Horyzons Platform and Attrition Over Time
Changes in engagement with Horyzons will be passively collected for client participants via the platform. Data evaluated will include number of logins, number of journeys, tracks, and activities completed, and number engagements on the community page.
Time frame: Baseline, up to Month 9
Other Pre-specified
Change in Use of Emergency and Social Services
Collection of use of emergency and social services pre-initiation and post-initiation of Horyzons will be assessed to determine change in use of such services.
Time frame: Baseline, up to Month 9