Study Summary
This trial is testing whether an online social media platform with therapeutic content, called Horyzons, can help people with first-episode psychosis. The trial will enroll clients from 4 FEP clinics in North Carolina, who will be assigned to one of two groups. Cohort 1 will have access to the platform for 3 months and cohort 2 will have access to the platform for 6 months. All interventions and assessments will be completed online/remotely due to the global pandemic.
Eligible Conditions
- Schizophrenia
- Schizophreniform Disorder
- Schizoaffective Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary Β· 4 Secondary Β· Reporting Duration: up to 6 months
Week 14
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support Subscale Score
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational Support Subscale Score
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social Interaction Subscale Score
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support Subscale Score
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score
Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score
Mean Change in Psychological Wellbeing Scale Short Form - Total Score
Mean Change in Social Interaction Anxiety Scale (SIAS) Score
Mean Change in UCLA Loneliness Scale Score
up to 20 weeks
Mean Change in Perceived Autonomy Support Scale - Total Score (Both Cohorts)
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts)
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts)
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts)
up to 6 months
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support Subscale Score (Both Cohorts)
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational Support Subscale Score (Both Cohorts)
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social Interaction Subscale Score (Both Cohorts)
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support Subscale Score (Both Cohorts)
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts)
Mean Change in Modified Colorado Symptom Index - Total Score (Cohort 2 Only)
Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score (Both Cohorts)
Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts)
Mean Change in Questionnaire about the Process of Recovery - Total Score (Cohort 2 Only)
Mean Change in Social Anxiety Scale for Social Media Users - Interaction Anxiety Subscale Score (Cohort 2 Only)
Mean Change in Social Anxiety Scale for Social Media Users - Privacy Concern Anxiety Subscale Score (Cohort 2 Only)
Mean Change in Social Anxiety Scale for Social Media Users - Self-Evaluation Anxiety Subscale Score (Cohort 2 Only)
Mean Change in Social Anxiety Scale for Social Media Users - Shared Content Anxiety Subscale Score (Cohort 2 Only)
Mean Change in Social Anxiety Scale for Social Media Users - Total Score (Cohort 2 Only)
Anxiety
Mean Change in Twente Engagement with E-health Technologies Scale - Total Score (Cohort 2 Only)
Mean Change in UCLA Loneliness Scale Score (Both Cohorts)
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Qualitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
Quantitative Summaries of Participant Experience in Post-Treatment Feedback
Quantitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
Trial Safety
Trial Design
1 Treatment Group
FEP Clients
1 of 1
Experimental Treatment
117 Total Participants Β· 1 Treatment Group
Primary Treatment: Horyzons USA Β· No Placebo Group Β· N/A
FEP Clients
Device
Experimental Group Β· 1 Intervention: Horyzons USA Β· Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,367 Previous Clinical Trials
3,919,564 Total Patients Enrolled
25 Trials studying Schizophrenia
2,624 Patients Enrolled for Schizophrenia
North Carolina Department of Health and Human ServicesOTHER_GOV
9 Previous Clinical Trials
171,636 Total Patients Enrolled
Diana Perkins, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill - School of Medicine
1 Previous Clinical Trials
2 Total Patients Enrolled
David Penn, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
17 Total Patients Enrolled
1 Trials studying Schizophrenia
17 Patients Enrolled for Schizophrenia
Eligibility Criteria
Age 18 - 35 Β· All Participants Β· 7 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments