Fostering Agricultural Relationships and Meaning - Thriving on Kinship (FARM-TOK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Mean change in loneliness
研究概览
简要总结
This study aims to enroll 65 participants who will be assigned to one of two groups. Each group will receive an intervention consisting of six weekly sessions of 40-60 minutes each. Eligibility includes residing in an agricultural area and reporting loneliness or feeling alone or disconnected.
详细描述
Individuals (n = 65) who reside in a agricultural area and report loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, or (2) therapist-delivered Health Education. Loneliness, quantity of social interactions, perceived social support, substance use outcomes, and other key outcomes and descriptive characteristics will be assessed at baseline, mid-treatment, post-treatment, and at a one-month follow-up. Participants will have the option to complete daily ecological momentary assessments (EMA) 3 times a day for 7 weeks via an app on their smartphone, Catalyst by MetricWire, throughout the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •able to provide informed consent
- •understand English
- •have internet access
- •reside in an agricultural area
- •screen positive for loneliness by scoring at least 44 on the 20-item UCLA Loneliness Scale
排除标准
- •unable to give informed consent
- •non-English speaking
- •does not have consistent access to a phone and/or internet
- •reports being diagnosed with a neurological disorder or a current psychotic or bipolar 1 diagnosis
- •current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer
研究组 & 干预措施
Cognitive-Behavioral Therapy
CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth
干预措施: Cognitive-Behavioral Therapy for Perceived Social Isolation (Behavioral)
Therapist-delivered Health Education
Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Mean change in loneliness
时间窗: Baseline to 6 months
Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Mean change in anxiety
时间窗: Baseline to 6 months
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in depression
时间窗: Baseline to 6 months
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in social interactions
时间窗: Baseline to 6 months
Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.
次要结局
未报告次要终点
研究者
Nicholas Allan
Assistant Professor
Ohio State University