■1型糖尿病(T1D)需要苛刻的自我管理健康行为,患有T1D的青少年有不良社会心理和医疗结果的风险。发展韧性技能可以帮助患有T1D和高度困扰的青少年度过常见的压力源并取得积极的结果。
■为了测试促进压力管理(PRISM)干预措施对血红蛋白A1c(HbA1c)水平的疗效,糖尿病困扰,自我管理行为,弹性,以及青少年的生活质量。
■此阶段3,并行,从2020年1月1日至2022年11月30日,在2家儿童医院中的每一家进行了1:1随机临床试验,对172名参与者进行了12个月的随访,在西雅图,华盛顿,还有休斯顿,德克萨斯州。参与者年龄为13至18岁,患有T1D至少12个月,并且糖尿病困扰升高。
■PRISM,一个手工的,基于技能,教授压力管理的个人干预计划,目标设定,重构,和意义的创造,由教练协助,并伴随着一个数字应用程序,在三个30到60分钟的会议中交付,大约间隔2周。
■两个主要结果,糖尿病困扰和HbA1c水平,和3个次要结果,弹性,生活质量,参与自我管理行为,在基线和基线后6个月和12个月进行评估。线性混合效应回归模型用于评估意向治疗人群在两个时间点的PRISM或常规治疗(UC)与这些结果之间的关联。
■在172名青少年中(平均[SD]年龄,15.7[1.6]年),96人是女性(56%),基线平均(SD)HbA1c水平为8.7%(2.0%).PRISM和UC接受者的HbA1c水平无明显差异(β,-0.21[95%CI,-0.65至0.22];P=0.33)或糖尿病困扰(β,-2.71[95%CI,-6.31至0.90];P=.14)或任何参与者报告的结果(例如,β,6个月时的2.25[95%CI,-0.30至4.80];自我管理行为P=.08)。12个月时,两组间HbA1c水平无统计学差异(β,-0.26[95%CI,-0.72至0.19];P=0.25);然而,PRISM接受者报告糖尿病困扰的改善明显更大(β,-4.59[95%CI,-8.25至-0.94];P=0.01)和自我管理行为的改善(β,3.4[95%CI,0.9至5.9];P=0.01)与UC接受者相比。
■这项12个月时与PRISM相关的社会心理和行为改善的随机临床试验的结果说明了基于优势的干预的价值。将韧性技能建设与传统糖尿病护理相结合可能是改善患有T1D和糖尿病恶化的青少年预后的有希望的方法。
■ClinicalTrials.gov编号:NCT03847194。
UNASSIGNED: Type 1 diabetes (T1D) requires demanding self-management health behaviors, and adolescents with T1D are at risk for poor psychosocial and medical outcomes. Developing resilience skills may help adolescents with T1D and elevated distress navigate common stressors and achieve positive outcomes.
UNASSIGNED: To test the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention on levels of hemoglobin A1c (HbA1c), diabetes distress, self-management behaviors, resilience, and quality of life among adolescents.
UNASSIGNED: This phase 3, parallel, 1:1 randomized clinical
trial that followed up 172 participants for 12 months was conducted from January 1, 2020, to November 30, 2022, at each of 2 children\'s hospitals, in Seattle, Washington, and Houston, Texas. Participants were ages 13 to 18 years with T1D for at least 12 months and elevated diabetes distress.
UNASSIGNED: PRISM, a manualized, skills-based, individual intervention program that teaches stress management, goal setting, reframing, and meaning-making, facilitated by a coach and accompanied by a digital app, was delivered in three 30- to 60-minute sessions approximately 2 weeks apart.
UNASSIGNED: The 2 primary outcomes, diabetes distress and HbA1c levels, and 3 secondary outcomes, resilience, quality of life, and engagement in self-management behaviors, were assessed at baseline and 6 and 12 months after baseline. Linear mixed-effects regression models were used to evaluate associations between PRISM or usual care (UC) and these outcomes at both time points for the intention-to-treat population.
UNASSIGNED: Among 172 adolescents (mean [SD] age, 15.7 [1.6] years), 96 were female (56%), and their baseline mean (SD) HbA1c level was 8.7% (2.0%). No differences were evident between PRISM and UC recipients in HbA1c levels (β, -0.21 [95% CI, -0.65 to 0.22]; P = .33) or diabetes distress (β, -2.71 [95% CI, -6.31 to 0.90]; P = .14) or any participant-reported outcome (eg, β, 2.25 [95% CI, -0.30 to 4.80]; P = .08 for self-management behaviors) at 6 months. At 12 months, there was no statistically significant difference between arms in HbA1c levels (β, -0.26 [95% CI, -0.72 to 0.19]; P = .25); however, PRISM recipients reported significantly greater amelioration of diabetes distress (β, -4.59 [95% CI, -8.25 to -0.94]; P = .01) and improvement in self-management behaviors (β, 3.4 [95% CI, 0.9 to 5.9]; P = .01) compared with UC recipients.
UNASSIGNED: The findings in this randomized clinical
trial of psychosocial and behavioral improvements associated with PRISM at 12 months illustrate the value of a strengths-based intervention. Integrating resilience skills-building with traditional diabetes care may be a promising approach for improving outcomes among adolescents with T1D and elevated diabetes distress.
UNASSIGNED: ClinicalTrials.gov number: NCT03847194.