A Pilot Study to Examine the Effects of Mindfulness Versus Values-plus-goals Interventions for Adults With Diabetes Treated With Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Diabetes Self-Management Questionnaire
研究概览
简要总结
Individuals with insulin-treated diabetes can experience psychological difficulties associated with living with and managing the condition. Acceptance and Commitment Therapy (ACT) is being increasingly used to treat these psychological difficulties, with research in this area indicating positive psychological and diabetes-related outcomes (Gregg, Callaghan, Hayes, & Glenn-Lawson, 2007; Shayeghian, Hassanabadi, Aguilar-Vafaie, Amiri, & Besharat, 2016). Given the lack of psychology funding in diabetes care provision, a financially feasible theory-based intervention is much-needed (Diabetes UK, 2008). ACT may be the solution as it can be delivered in smaller modules.
The study aims to investigate the effectiveness of two online ACT-based interventions (a mindfulness-based intervention [MBI] and a values-plus-goals intervention [VGI]) on wellbeing, diabetes self-management, coping style and glycaemic control among a sample of adults with insulin-treated diabetes. It also aims to examine whether the interventions are associated with changes in diabetes acceptance and valued living, and whether diabetes acceptance and valued living are associated with the aforementioned outcomes.
Participants will be recruited from the diabetes outpatient clinics at Ashford and St. Peter's Hospitals NHS Foundation Trust to take part in the study. They will be randomly assigned to take part in either the MBI or VGI, which are both 4-week interventions. Participants will be asked to complete self-report questionnaires to measure their wellbeing, diabetes self-management, coping style, diabetes acceptance and valued living at the beginning of the study, at the end of the intervention and at a 1-month follow-up. Glycaemic control will be measured at the beginning of the study and at a 2-month follow up.
It is hypothesised that both interventions will improve diabetes-related outcomes. It is hypothesised that MBI may be associated with increases in acceptance and more positive emotion focused coping, whereas the VGI may be associated with increased valued living and problem-focused/active coping.
详细描述
Background
Diabetes is a long-term condition which affects the way the body regulates blood sugar in around 4.7 million people in the United Kingdom (Diabetes UK, 2019). There are two types of diabetes: Type 1 is when an individual is unable to produce any insulin, which is a hormone that allows sugar to enter the cells in our bodies, and Type 2 is when an individual no longer responds to insulin (Diabetes UK. 2019). Type 1 Diabetes is treated using insulin therapy and some people with Type 2 Diabetes will also need insulin therapy (DeWitt & Hirsch, 2003).
Individuals with diabetes have a greater risk of experiencing heart attacks, stroke and cardiovascular diseases, and complications from the condition such as amputations, sight loss and kidney disease (Diabetes UK, 2019). They also face many psychological challenges associated with managing the condition, such as depression, diabetes-related distress, and negative coping strategies, which can lead to poorer diabetes self-management (Rane, Wajngot, Wändell, & Gåfvels, 2011). According to the annual diabetes prevalence figures published in 2019 by Diabetes UK, around 40% of people with diabetes experience psychological difficulties and up to 65% can experience low mood related to their diabetes. Those with mental health difficulties seeking physical treatment can cost the NHS up to 50% more than those without mental health difficulties (Diabetes UK, 2019).
Psychological interventions and Acceptance and Commitment Therapy A range of psychological interventions have been used to treat individuals with diabetes, such as psychoeducation about diabetes self-management, problem-solving approaches and Cognitive Behavioural Therapy, which aims to challenge negative thoughts (Thorpe, Fahey, & Johnson, 2012). However, due to the realistic nature of thoughts related to chronic health conditions at times, approaches that challenge thoughts have limited effectiveness for some individuals (Hofmann, Sawyer, & Fang, 2010).
Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999) may be a promising approach for use with the diabetes population. It is a therapeutic approach that is increasingly being used to treat psychological difficulties experienced by individuals with health conditions, as it moves away from attempts to alter internal experiences and promotes value-based living alongside our internal experiences. There is an emerging evidence base for the use of ACT with diabetes. Gregg, Callaghan, Hayes and Glenn-Lawson (2007) demonstrated that it is effective in improving coping styles, diabetes self-management and blood sugar control among adults with diabetes. ACT has been shown to be effective in improving diabetes-related outcomes in other studies as well (e.g. Shayeghian, Hassanabadi, Aguilar-Vafaie, Amiri, & Besharat, 2016). It has been delivered online successfully in the diabetes population through the use of smartphones, suggesting that it is feasible and effective in reducing anxiety, depression and diabetes-related distress (e.g. Nes et al., 2012; NHS Grampian, 2015).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes or type 2 diabetes treated with insulin
- •Recent HbA1c value of 64 mmol/mol or higher
- •At least 18 years of age
- •Fluent in written and spoken English
- •Access to the Internet to access the intervention
排除标准
- •People with diabetes treated with diet and/or tablets alone
- •Non-English speakers
- •Aged under 18 years
- •No Internet access
- •Severe and enduring mental health problems
- •Presence of another serious and/or life-threatening physical condition
- •Cognitive and/or visual impairment
- •Currently accessing psychological treatment
结局指标
主要结局
Change in Diabetes Self-Management Questionnaire
时间窗: T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up)
Diabetes Self-Management Questionnaire (DSMQ; Schmitt et al., 2013) is a 16-item measure of self-care activities associated with glycaemic control. Each item is scored on a 4-point Likert scale from 'applies to me very much' (score of 3) to 'does not apply to me' (score of 0). The measure is composed of four subscales: 'Glucose Management', 'Dietary Control', 'Physical Activity' and 'Health-Care Use'. Schmitt et al. (2013) have shown that the DSMQ has good internal consistency (0.84) and significant convergent correlations with parallel scales of self-management and HbA1c levels.
次要结局
- Change in Well-Being Questionnaire(T1 (start of intervention), T2 (end of intervention), T3 (1-month follow-up))
- Change in Brief COPE(T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up))
- Change in Diabetes Acceptance Scale(T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up))
- Change in Valued Living Questionnaire(T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up))
- Change in HbA1c level(T1 (start of intervention), T3 (2-month follow-up))
研究者
Sophini Logeswaran
Chief Investigator
Royal Holloway University