Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percentage of Enrolled of Eligible Participants Screened
研究概览
简要总结
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 12-17y
- •T1D, with at least 1-year duration of illness
- •negative affectivity, defined as clinically elevated scores (T-score >55 indicating at least mild depression/anxiety symptoms on either the PROMIS short form-depression and/or anxiety scales)
- •A1c >7.5%
- •English-speaking
排除标准
- •no cognitive or developmental delays which would interfere with their ability to participate in the study
- •are able and willing to complete questionnaires and intervention via the internet
- •do not have severe depression or active or recent (within the past two months) suicidal ideation
- •have no other serious medical conditions (e.g., cystic fibrosis, cancer).
结局指标
主要结局
Percentage of Enrolled of Eligible Participants Screened
时间窗: During screening (10 months total)
The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.
Number of Weeks to Enroll Participants to Form One Cohort
时间窗: During screening (10 months)
Number of weeks to enroll 10 participants to be randomized 5 per group
Percentage of Participants With Data Collected
时间窗: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Number of participants with data at each time point.
Percentage of Attended Sessions
时间窗: Immediate post-intervention follow-up (2-3 months post baseline)
Number of intervention sessions (calculated by multiplying number of expected sessions by number of participants for total possible sessions held) attended divided by total number of intervention sessions expected per group.
Satisfaction With Intervention Program
时间窗: Immediate post-intervention follow-up (2-3 months post-baseline)
Satisfaction report by participants
次要结局
- Mindful Attention Awareness Scale(Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Five-Facet Mindfulness Questionnaire(Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline))
- PROMIS Depression Short Form - Adolescent Report(Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- PROMIS Anxiety Short Form - Adolescent Report(Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Diabetes Eating Problems Survey Revised(Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- UPPS-P Negative Urgency Subscale(Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Self-Care Inventory(Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Problem Areas in Diabetes - Teen(Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Glycemic Control(Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline))
- Interventionist Adherence to Session Manuals(Week 6 of intervention)
研究者
Eleanor Mackey
Associate Professor
Children's National Research Institute