Chew Boon How, Vos Rimke C, Metzendorf Maria-Inti, Scholten Rob Jpm, Rutten Guy Ehm
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht, Netherlands, 3508 GA.
Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011469. doi: 10.1002/14651858.CD011469.pub2.
Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms.
To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM.
We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases.
We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects.
Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates.
We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA.
AUTHORS' CONCLUSIONS: Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.
许多成年2型糖尿病(T2DM)患者承受着与疾病相关的社会心理负担和心理健康问题。糖尿病相关困扰(DRD)对自我护理行为和疾病控制有显著影响。改善成年T2DM患者的DRD可增强心理健康、健康相关生活质量、自我护理能力并控制疾病,还可减轻抑郁症状。
评估心理干预对成年T2DM患者糖尿病相关困扰的影响。
我们检索了考克兰图书馆、MEDLINE、Embase、PsycINFO、CINAHL、BASE、世界卫生组织国际临床试验注册平台检索门户和ClinicalTrials.gov。BASE的最后检索日期为2014年12月,其他所有数据库的最后检索日期为2016年9月21日。
我们纳入了关于心理干预对18岁及以上成年T2DM患者DRD影响的随机对照试验(RCT)。如果试验比较了不同的心理干预或比较了心理干预与常规护理,我们则将其纳入。主要结局为DRD、健康相关生活质量(HRQoL)和不良事件。次要结局为自我效能感、糖化血红蛋白A1c(HbA1c)、血压、糖尿病相关并发症、全因死亡率和社会经济影响。
两位综述作者独立确定纳入的出版物并提取数据。我们根据干预措施对情绪、认知或情绪 - 认知的关注程度对其进行分类。我们进行随机效应荟萃分析以计算总体估计值。
我们确定了30项RCT,共9177名参与者。16项试验为平行双臂RCT,7项为三臂平行试验。还有7项整群随机试验:2项有四个组,其余5项有两个组。干预的中位持续时间为6个月(范围1周至24个月),中位随访期为12个月(范围0至12个月)。试验包括广泛的干预措施,既有个体干预也有团体干预。
所有心理干预措施与常规护理联合进行的荟萃分析显示,对DRD(标准化均数差(SMD)-0.07;95%置信区间 -0.16至0.03;P = 0.17;3315名参与者;12项试验;低质量证据)、HRQoL(SMD 0.01;95%置信区间 -0.09至0.11;P = 0.87;1932名参与者;5项试验;低质量证据)、全因死亡率(每1000人中有11人 vs 每1000人中有11人;风险比(RR)1.01;95%置信区间0.17至6.03;P = 0.99;1376名参与者;3项试验;低质量证据)或不良事件(每1000人中有17人 vs 每1000人中有41人;RR 2.40;95%置信区间0.78至7.39;P = 0.13;438名参与者;3项试验;低质量证据)均无确切影响。我们在中期随访(6至12个月)时看到对自我效能感和HbA1c有小的有益影响:自我效能感方面,SMD为0.15(95%置信区间0.00至0.30;P = 0.05;2675名参与者;6项试验;低质量证据),支持心理干预;HbA1c方面,平均差(MD)为 -0.14%(95%置信区间 -0.27至0.00;P = 0.05;3165名参与者;11项试验;低质量证据),支持心理干预。我们纳入的试验未报告糖尿病相关并发症或社会经济影响。
许多试验规模较小,因结局数据不完整以及基于主观问卷的结局评估中可能存在的实施和检测偏倚而存在高偏倚风险,一些试验似乎存在选择性报告的风险。有4项试验等待进一步分类。这些是聚焦认知和聚焦情绪 - 认知干预的平行RCT。另外还有18项正在进行的试验,可能聚焦于情绪 - 认知或认知,评估糖尿病自我管理支持、电话认知行为疗法、压力管理以及糖尿病管理问题解决网络应用等干预措施。这些试验大多在社区环境中进行,且以美国为基地。
低质量证据表明,没有哪种心理干预措施在改善DRD方面比常规护理更有效。心理干预后自我效能感和HbA1c有所改善的证据质量较低。这意味着我们不确定心理干预对这些结局的影响。然而,与常规护理相比,心理干预可能没有实质性不良事件。需要在非美国和非欧洲环境以及低收入和中等收入国家开展更多以情绪为重点方案的高质量研究。