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临床试验/NCT03077997
NCT03077997终止不适用

Acceptability and Clinical Feasibility of an Internet-delivered Intervention for Psychological Distress in Patients With Type 2 Diabetes

Derek Richards1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Diabetes Distress (As measured by the Diabetes Distress Scale)

研究概览

简要总结

Diabetes distress is a psychological phenomenon associated with the self-management of the disease and is characterised by feelings of anxiety, guilt, helplessness, defeat, and depression. Research suggests that internet-delivered interventions have the potential to increase people's ability to self-manage their symptoms, but whether they are effective is largely unknown. This study is designed to investigate the potential effectiveness of an internet-delivered intervention for diabetes distress in patients with type 2 diabetes.

详细描述

Diabetes is a chronic metabolic endocrine disorder characterised by the inability to metabolise glucose effectively. It is associated with reduced life expectancy, significant morbidity due to specific diabetes related complications, and increased risk of complications such as heart disease, stroke, and diminished quality of life. The incidence of diabetes is on the increase with approximately 347 million adults affected worldwide. Type 2 diabetes accounts for 90-95% of these cases and figures are estimated to increase to 552 million by 2030.

Lifestyle changes such as a reduction in exercise and an increase in dietary intake over the past number of years have been flagged as being responsible for this dramatic surge in the prevalence of Type 2 diabetes on a global scale.

Because diabetes is a chronic and progressive condition people not only require regular access to medical care, but the ability to self-manage symptoms on a daily basis is now considered to be an essential part of treatment. Self-management involves the continuous monitoring of dietary intake, physical activity, general health, stress levels, blood sugar levels, and adherence to medication regimens. Diabetes is a demanding illness that requires complex self-management maintenance/care on a daily basis. Coping with these demands and maintaining lifestyle changes can often be overwhelming for individuals and this can result in significant distress that includes feelings of anxiety, guilt, helplessness, defeat, and depression.

Research has demonstrated that those who display high levels of such symptoms are not necessarily clinically depressed; rather they experience high levels of emotional distress related to diabetes and their management of the disease. Diabetes distress is a distinct condition that directly relates to diabetes outcomes. It is characterised by unique emotional issues that directly relate to the burden of living with diabetes such as worry, frustration, concern and aspects of burnout.

Several factors prevent people with diabetes from accessing support and treatment for any distress they may experience in self-managing, such as poor education, personal finances, physical access to services, lack of social support, poor motivation, low self-efficacy, and negative attitudes to treatments. In addition the concept of diabetic distress is relatively new and unknown. This highlights the growing need to develop effective treatment options to overcome barriers to access for people with type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 25-
  • •Have type 2 diabetes for five years or more.
  • •Have internet access

排除标准

  • •Outside of age criteria.
  • •Does not have type 2 diabetes for five years or more.
  • •No internet access

研究组 & 干预措施

Space from Diabetes

Experimental

Participants will be assigned the 'Space from Diabetes' intervention in a supported mode for 8 weeks. Participants are assigned a clinical supporter, who will be a psychological well-being practitioner in an NHS Mental Health Service. As the participant works through the programme content, the supporter will provide them with a review of their progress and interactions with the platform 6 times over the 8 week supported period.

干预措施: Space from Diabetes (Behavioral)

结局指标

主要结局

Diabetes Distress (As measured by the Diabetes Distress Scale)

时间窗: At the end of treatment (week 8)

Diabetes Distress Scale (DDS; Polonsky et al., 2005; Fisher et al., 2008) is a 17-item measure that focuses on 4 aspects of distress associated with diabetes: emotional burden, regimen distress, interpersonal distress and physician distress. The measure and its 4 subscales have demonstrated good internal consistency (α \> .87) and convergent validity with the Center for Epidemiological Studies Depression Scale, meal planning, exercise and total cholesterol (Polonsky et al., 2005).

次要结局

  • Depression (as measured by the Patient Health Questionnaire)(At the end of treatment (week 8))
  • Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)(At the end of treatment (week 8))
  • Work and Social Adjustment(At the end of treatment (week 8))
  • Satisfaction with Treatment(End of treatment (week 8))
  • EuroQol 5D5L(At the end of treatment (week 8))

研究者

发起方
Derek Richards
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Derek Richards

Director of Clinical Research and Innovation

Silver Cloud Health

研究点 (1)

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