接受与承诺疗法方案对糖化血红蛋白水平升高的 1 型糖尿病成人的糖化血红蛋白、自我管理和心理社会因素的影响：一项随机对照试验。
Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial.
机构信息
Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden
Department of Health Care Sciences, Marie Cederschiöld University, Stockholm, Sweden.
出版信息
BMJ Open. 2023 Dec 14;13(12):e072061. doi: 10.1136/bmjopen-2023-072061.
OBJECTIVE
To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).
SETTING
An endocrinologic clinic in Sweden.
PARTICIPANTS
In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18-70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.
INTERVENTION
The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.
OUTCOMES
The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.
RESULTS
Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (χ=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test χ=12.63, p<0.001) was observed with improved scores on The Acceptance and Action Questionnaire in the intervention group after 1 and 2 years.
CONCLUSIONS
No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.
TRIAL REGISTRATION NUMBER
NCT02914496.
目的
评估针对 1 型糖尿病患者量身定制的接受与承诺疗法 (ACT) 方案对糖化血红蛋白 (HbA1c)、自我管理和心理社会因素的影响，与常规治疗 (TAU) 相比，HbA1c 水平>60mmol/mol 的个体。
设置
瑞典内分泌诊所。
参与者
在这项随机对照试验中，81 名年龄在 18-70 岁之间、HbA1c>60mmol/mol 的 1 型糖尿病患者被随机分配到 ACT 组干预或 TAU 组。排除标准为：不会说瑞典语、未治疗或严重精神疾病、皮质激素治疗、未经治疗的甲状腺疾病和新开始胰岛素泵治疗。在 2 年随访时，有 26 名个体测量了 HbA1c。
干预
ACT 方案包括 7 个 2 小时的课程，共 14 周，重点是接受压力下的思想和情绪，并促进基于价值的承诺行动。
结果
主要结局是 HbA1c，次要结局是抑郁、焦虑、一般压力、低血糖恐惧、糖尿病困扰、自我护理活动、心理灵活性（一般和与糖尿病相关）和生活质量的测量。主要终点是干预方案 2 年后的 HbA1c。线性混合模型用于检验测量时间和组之间的交互效应。
结果
嵌套模型的似然比检验表明，HbA1c 方面，测量时间和组之间没有统计学上显著的交互效应（χ=0.49，p=0.485）。然而，在干预组中，接受与行动问卷的评分在 1 年和 2 年后都有统计学上显著的交互效应（似然比检验 χ=12.63，p<0.001）。
结论
两组在主要结局测量 HbA1c 方面无统计学差异。然而，ACT 方案显示出对干预组心理灵活性的持续有益影响。失访率高于预期，这可能表明这种类型的研究存在挑战。
试验注册号
NCT02914496。
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