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临床试验/NCT03999385
NCT03999385Unknown不适用

Growth and Self-Care: The Use of Mindfulness-Based Interventions to Assist Emerging Adults With Diabetes Transition to Adulthood

University of Manitoba2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change in average plasma glucose concentration

研究概览

简要总结

The transition from pediatric to adult care is particularly difficult for individuals with Type 1 diabetes. It is hypothesized that a mindfulness-based intervention for individuals making this transition will contribute to personal psychological well-being, superior participation in health care, and more tightly controlled blood sugar levels. Young adults with Type I diabetes will complete an eight-week training program in Mindful Self-Compassion. Intervention effectiveness will be assessed with both self-report and physiological measures. Assessments will occur at the start of the training program, end of the program, and three-months post-program.

详细描述

This research will evaluate the consequences of an eight-week Mindful Self-Compassion (MSC) intervention on the psychological and physical well-being of 18 to 25 year-old individuals with Type 1 diabetes who are at an age of established risk. Participants will be randomly assigned to either an immediate intervention group or wait-list control group. All participants will be tested before and after the intervention on a battery of self-report measures designed to assess various aspects of self-care and psychological functioning. Blood samples will also be taken before and after the intervention to determine HbA1C levels. Participants will also receive a followup assessment three-months post-intervention to assess the durability of the effects. We expect MSC training to induce positive change in participants' diabetes management and personal well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between the ages of 18 and 25
  • Obtain care for Type 1 diabetes

排除标准

  • Psychologically or medically unable to complete the MSC program

研究组 & 干预措施

Immediate Training Group

Experimental

8 weeks of training in Mindful Self-Compassion.

干预措施: Mindful Self-Compassion (MSC) (Behavioral)

Waitlist Control Group

Other

No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion.

干预措施: Mindful Self-Compassion (MSC) (Behavioral)

结局指标

主要结局

Change in average plasma glucose concentration

时间窗: Baseline, 8 weeks, and 3 months

Assessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management.

Change in diabetes self-management

时间窗: Baseline, 8 weeks, and 3 months

Assessed by total scores and subscale scores on the Summary of Diabetes Self-Care Activities (Toobert, Hampson, \& Glasgow, 2000), which range from 0 to 7 when item scores are averaged. The items assess general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The desired outcome is a statistically significant increase in diabetes self-management.

次要结局

  • Change in Negative Affect(Baseline, 8 weeks, and 3 months)
  • Change in Life Engagement(Baseline, 8 weeks, and 3 months)
  • Change in Eating Disorder Symptomatology(Baseline, 8 weeks, and 3 months)
  • Change in Mindfulness(Baseline, 8 weeks, and 3 months)
  • Change in Fears of Compassion(Baseline, 8 weeks, and 3 months)
  • Change in Positive Affect(Baseline, 8 weeks, and 3 months)
  • Change in Self-compassion(Baseline, 8 weeks, and 3 months)
  • Change in Perceived Stress(Baseline, 8 weeks, and 3 months)
  • Change in Health Locus of Control(Baseline, 8 weeks, and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael McIntyre

Principal Investigator

University of Manitoba

研究点 (2)

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