Horyzons: Implementation in Clinical Practice

Schizophrenia Clinical Trial

Official title:

Horyzons: Implementation in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673851
• Other study ID #: 19-1709
• Status: Completed
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders
• Schizophreniform Disorders
• Unspecified Schizophrenia Spectrum and Other Psychotic Disorder

Intervention

Device:
• Horyzons USA
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational Support Subscale Score (Both Cohorts)	The MOS Social Support Survey - Emotional/informational support subscale is an 8 item subscale. 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 8 to 40. Higher scores reflect higher feelings of emotional and informational social support (more perceived emotional and informational social support). The MOS Social Support Survey - Emotional/informational support subscale 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
Other	Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support Subscale Score (Both Cohorts)	The MOS Social Support Survey - Tangible support subscale is a 4 item subscale. 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 4 to 20. Higher scores reflect higher feelings of tangible social support (more perceived tangible social support). The MOS Social Support Survey - Tangible support subscale 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
Other	Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support Subscale Score (Both Cohorts)	The MOS Social Support Survey - Affectionate support subscale is a 3 item subscale. 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 3 to 15. Higher scores reflect higher feelings of affectionate social support (more perceived affectionate social support). The MOS Social Support Survey - Affectionate support subscale 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
Other	Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social Interaction Subscale Score (Both Cohorts)	The MOS Social Support Survey - Positive social interaction subscale is a 3 item subscale. 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 3 to 15. Higher scores reflect higher feelings of positive social interaction (more perceived positive social interaction). The MOS Social Support Survey - Positive social interaction subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Environmental Mastery Subscale is a 3 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 3 to 18. Higher scores reflect higher levels of environmental mastery. The MOS Social Support Survey - Environmental Mastery subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Personal Growth subscale is a 3 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 3 to 18. Higher scores reflect higher levels of personal growth. The Psychological Wellbeing Scale - Personal Growth subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Self-Acceptance subscale is a 3 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 3 to 18. Higher scores reflect higher feelings of self-acceptance. The Psychological Wellbeing Scale - Self-Acceptance subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Autonomy Subscale is a 3 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 3 to 18. Higher scores reflect higher levels of autonomy. The Psychological Wellbeing Scale - Autonomy subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Positive Relationships subscale is a 3 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 3 to 18. Higher scores reflect higher levels of positive relationships. The Psychological Wellbeing Scale - Positive Relationships subscale 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
Other	Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score (Both Cohorts)	The Psychological Wellbeing Scale (Short Form) - Purpose in Life subscale is a 3 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 3 to 18. Higher scores reflect higher feelings of purpose in life. The Psychological Wellbeing Scale - Purpose in Life subscale 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
Other	Qualitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)	This qualitative data will be collected post-treatment from clients and clinicians. Focus groups and individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).	up to 6 months
Other	Quantitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)	This quantitative data will be collected post-treatment from clients and clinicians. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with higher scores reflecting a more positive experience. Frequency counts will be included here. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).	up to 6 months
Other	Mean Change in Questionnaire about the Process of Recovery - Total Score (Cohort 2 Only)	The Questionnaire about the Process of Recovery (QPR) - Total Score is a 15-item scale. Answers are rated on a 5-point scale with options "disagree strongly", "disagree", "neither agree nor disagree", "agree", and "agree strongly. Possible scores range from 0 to 60. Higher scores are indicative of recovery. The QPR is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Modified Colorado Symptom Index - Total Score (Cohort 2 Only)	The Modified Colorado Symptom Index - Total Score is a 14-item scale. Answers are rated on a 4-point scale with options "not at all", "once during the month", "several times during the month", "several times a week", and "at least every day". Possible scores range from 0 to 56. Higher scores indicate greater emotional distress. The Modified Colorado Symptom Index is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Social Anxiety Scale for Social Media Users - Total Score (Cohort 2 Only)	The Social Anxiety Scale for Social Media Users (SAS-SMU) - Total Score is a 21-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 21 to 105. Higher scores reflect greater anxiety related to social media usage. The SAS-SMU is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Social Anxiety Scale for Social Media Users - Shared Content Anxiety Subscale Score (Cohort 2 Only)	The Social Anxiety Scale for Social Media Users (SAS-SMU) - Shared Content Anxiety subscale is a 7-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 7 to 35. Higher scores reflect greater anxiety related to sharing or creating content on social media. The SAS-SMU - Shared Content Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Social Anxiety Scale for Social Media Users - Privacy Concern Anxiety Subscale Score (Cohort 2 Only)	The Social Anxiety Scale for Social Media Users (SAS-SMU) - Privacy Concern Anxiety subscale is a 5-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 5 to 25. Higher scores reflect greater anxiety related to privacy concerns on social media. The SAS-SMU - Privacy Concern Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Social Anxiety Scale for Social Media Users - Interaction Anxiety Subscale Score (Cohort 2 Only)	The Social Anxiety Scale for Social Media Users (SAS-SMU) - Interaction Anxiety subscale is a 6-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 6 to 30. Higher scores reflect greater anxiety related to social interactions over social media. The SAS-SMU - Interaction Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Social Anxiety Scale for Social Media Users - Self-Evaluation Anxiety Subscale Score (Cohort 2 Only)	The Social Anxiety Scale for Social Media Users (SAS-SMU) - Self-Evaluation Anxiety subscale is a 3-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 3 to 15. Higher scores reflect greater anxiety related to negative self-evaluation. The SAS-SMU - Self-Evaluation Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).	up to 6 months
Other	Mean Change in Perceived Autonomy Support Scale - Total Score (Both Cohorts)	The Perceived Autonomy Support Scale - Total Score is a 6-item scale. Answer are on a 7-point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "neutral", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 6 to 42. Higher scores reflect greater perceived autonomy support. The Perceived Autonomy Support Scale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).	up to 20 weeks
Other	Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts)	The Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score is a 12-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 12 to 60 (summed) or 1 to 5 (averaged). Higher scores reflect greater therapeutic alliance. The WAI-I is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).	up to 20 weeks
Other	Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts)	The Working Alliance Inventory for Guided Internet Interventions - Bond subscale score is a 4-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 4 to 20 (summed) or 1 to 5 (averaged). Higher scores reflect greater bond with a clinician. The WAI-I - Bond subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).	up to 20 weeks
Other	Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts)	The Working Alliance Inventory for Guided Internet Interventions - Goal/Task Score is an 8-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 8 to 40 (summed) or 1 to 5 (averaged). Higher scores reflect greater shared goals and tasks with a clinician. The WAI-I - Goal/Task subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).	up to 20 weeks
Other	Mean Change in Twente Engagement with E-health Technologies Scale - Total Score (Cohort 2 Only)	The Twente Engagement with E-health Technologies Scale - Total Score is a 9-item scale. Answers are on a 5-point scale with options "strongly disagree", "disagree", "neutral", "agree", and "strongly agree". Possible scores range from 0 to 36. Higher scores reflect greater engagement. The Twente Engagement with E-health Technologies Scale is administered in only cohort 2 (Baseline, 1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).	up to 6 months
Primary	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
Primary	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	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
Secondary	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