Horyzons: Implementation in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Mean Change in UCLA Loneliness Scale Score (Both Cohorts)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Change in UCLA Loneliness Scale Score (Both Cohorts)
时间窗: 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)
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).
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts)
时间窗: 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)
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).
次要结局
- Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts)(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))
- Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts)(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))