Modifiers and Mechanisms of Loneliness Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- High frequency heart rate variability (HF-HRV)
研究概览
简要总结
A specific aim of this research is to identify the role of emotion regulation in response to social threat in caregivers' response to a behavioral coaching intervention for loneliness. A second aim of the study is to determine the benefit of a digitized, social engagement prioritization tool for improving coaches' intervention fidelity and caregiver outcomes. This study is funded through the Pilot Award Program of the Rochester Roybal Center for Social Ties & Aging Research, a UR Center funded by the National Institute on Aging by grant P30AG064103.
详细描述
The objective of this Stage III mechanistic study is to help identify additional modifiable targets and scalable approaches to support further development of highly effective, mechanistic-informed approaches to reducing loneliness and improving social connectedness in caregivers. This study is a Stage III, 19-month 2 (groups) x 2 (assessment timepoints) randomized clinical trial (RCT) aimed at identifying whether lonely caregivers' capacity, is associated with the degree to which loneliness is reduced in response to social engagement intervention (S-ENG). Further, the study will address whether a digitized, social engagement prioritization tool (C4C) used in the first session of S-ENG can improve intervention fidelity and
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver (age 50 or older) for a community-dwelling loved one with Alzheimer's disease or related dementia (ADRD), living with (or in close proximity to) the person with ADRD.
- •Elevated caregiving distress: above population mean (>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score >= 5) on the Modified Caregiver Strain Index.
- •Social disconnection: UCLA Loneliness Scale: Short Form score of > 5.
排除标准
- •Non-English speaking
- •Significant cognitive impairment
- •Major cardiovascular conditions that may interfere with reliable assessment of HRV (e.g., congestive heart failure, pacemaker, prior myocardial infarction).
研究组 & 干预措施
Social Engage Coaching
Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving for increasing social connectedness.
干预措施: Social Engage Coaching (Behavioral)
Social Engage Coaching with Connect for Caregivers
Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving, guided by use of a digitized prioritization tool, for increasing social connectedness.
干预措施: Social Engage Coaching (Behavioral)
Social Engage Coaching with Connect for Caregivers
Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving, guided by use of a digitized prioritization tool, for increasing social connectedness.
干预措施: Connect for Caregivers (Behavioral)
结局指标
主要结局
High frequency heart rate variability (HF-HRV)
时间窗: 11 weeks
HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform collected during a rest period, and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (absolute power of the high-frequency band (0.15-0.4 Hz) in ms-squared) reflects greater parasympathetic regulation of the heart.
Loneliness
时间窗: 11 weeks
UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).
Affect (valence) from Self-Assessment Manikin
时间窗: 11 weeks
Mean valence score during negatively valenced social pictures. The Self-Assessment Manikin is a non-verbal pictorial assessment technique that directly measures a person's affect in response to positive, negative, and neutrally valenced pictures. Affect valence is measured on a 9-point scale: 1 (very unpleasant) - 9 (very pleasant).
Dot probe task
时间窗: 11 weeks
Difference in response times (in milliseconds) to dots appearing in the location of a previously shown negative versus the neutral face.
Stroop Task
时间窗: 11 weeks
Difference in response time (in ms) to congruent versus incongruent trials, where congruent trials presented, for example, a positive social word spoken in a positive tone of voice whereas incongruent trials presented, for example, a positive social word spoken in a negative tone of voice. Negative values indicate longer response times to incongruent trials (interpreted as greater cognitive interference/distraction when trying to determine the semantic meaning (positive or negative) of a word when the vocal tone is inconsistent with the semantic meaning of the word.
High Frequency Heart Rate Variability (HF-HRV)
时间窗: 11 weeks
HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform collected during a rest period, and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (absolute power of the high-frequency band (0.15-0.4 Hz) in ms-squared) reflects greater parasympathetic regulation of the heart.
Dot Probe Task
时间窗: 11 weeks
Difference in response times (in milliseconds) to dots appearing in the location of a previously shown negative versus the neutral face. Negative values indicate a shorter response time to negative versus neutral faces (interpreted as a greater attentional bias to negative versus neutral faces).
Affect (Valence) From Self-Assessment Manikin
时间窗: 11 weeks
Mean valence score during negatively valenced social pictures. The Self-Assessment Manikin is a non-verbal pictorial assessment technique that directly measures a person's affect in response to positive, negative, and neutrally valenced pictures. Affect valence is measured on a 9-point scale: 1 (very unpleasant) - 9 (very pleasant).
次要结局
- Flanker Task(11 weeks)
- Set-Shifting Task(11 weeks)
研究者
Kathi Heffner
Professor
University of Rochester