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临床试验/NCT02600091
NCT02600091已完成不适用

Exploring the Effectiveness of Mindfulness-based Cognitive Therapy to Improve Emotional Wellbeing and Glycaemic Control Among Adults With Diabetes

University of Aberdeen1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Recruitment/Retention Rates

研究概览

简要总结

Type 1 and 2 diabetes are challenging conditions to manage. Anxiety and depression are common among this group and are associated with poorer diabetes control. No trials have been conducted to ascertain the effectiveness of psychological interventions designed to alleviate significant levels of anxiety and/or depression and improve glycaemic control among those with diabetes who have significant difficulties with their emotional wellbeing and diabetes control.

The aim of this project is to establish if it is feasible to run a multi-site randomised controlled trial in Scotland exploring whether an 8-week mindfulness and self-management based intervention programme decreases anxiety and/or depression, and improves diabetes control. This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, and pave the way for a larger and definitive trial.

详细描述

This is a feasibility trial informed by the MRC guidelines. It is a small RCT, where participants are randomised to either the MBCT intervention or waiting list control. Participants will be receiving their diabetes care in Aberdeen and Glasgow, and randomisation will occur at each site. The participants who are allocated to the waiting list control group will receive the MBCT intervention 3 months after the intervention group complete their MBCT programme.

The investigators will recruit participants using posters and leaflets, word of mouth from diabetes professionals, and from writing to those who are eligible. All of these methods are simply to raise awareness of the study. The intervention requires considerable commitment from participants (as indicated below) and this will be fully explained and explored. It will be up to potential participants to make initial contact with the research team, at which point they will be invited to the diabetes outpatient clinic for a discussion about what the project entails, the nature of mindfulness, and to go through the usual consent procedure.

In the cases of those people who agree to participate, the investigators will write to their GP and to their diabetes consultant to let them know that their patient has enrolled in the study, and provide brief information about the project.

The MBCT intervention is manualised and delivered to groups. The aim of the MBCT intervention is to increase mindfulness skills and to facilitate their use in relation to emotional wellbeing and diabetes self-management. Participants will attend on 8 occasions, once per week, for 2 hours. These meetings will have a standard structure. First, participants will describe their efforts to practice mindfulness at home over the previous week, followed by discussion of an educational topic relevant to the aims of the course. Finally, the group will do a mindfulness practice together, and the home practice for the following week will be set. In-between meetings, participants are asked to practice mindfulness by listening to an audio file or CD for about 30 minutes per day.

The research assistants will administer brief, self-report inventories at baseline; post-treatment and at 3 months follow-up to establish participants' level of mindfulness (Cognitive and Affective Mindfulness Scale-Revised);

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

  • •Adults (over the age of 18 years)
  • •Type 1 or Type 2 diabetes, diagnosed at least 1 year ago
  • •Mild to moderate levels of anxiety and/or depression (ie, HADS scores of ≥ 8)
  • •Most recent HbA1c value of ≥ 75 mmol/mol (Type 1) or ≥ 61 mmol/mol (Type 2).

排除标准

  • •Severe mental health problems (such as severe depression with suicidal ideation, psychosis, personality disorder)
  • •Terminal illness
  • •Inability to give informed consent in English
  • •Inability to understand written and spoken English.

研究组 & 干预措施

MBCT Intervention

Experimental

Participants in the Mindfulness-based Cognitive Therapy Intervention arm will receive an 8-week programme in mindfulness-based cognitive therapy

干预措施: Mindfulness-Based Cognitive Therapy (Behavioral)

Waiting List Control

No Intervention

The participants who are allocated to the waiting list control group will receive usual care. They will receive the MBCT intervention 3 months after the intervention group complete their MBCT programme.

结局指标

主要结局

Recruitment/Retention Rates

时间窗: 20 months

This study aims to establish if a large scale, definitive RCT of a specifically designed mindfulness-based group intervention, with self-management activation embedded within the programme structure, for adults with diabetes and significant emotional distress, is feasible, justified, and potentially cost-effective. The primary outcome, which will decide whether or not a full trial is feasible, will be based on rates of recruitment and retention of participants.

次要结局

  • Acceptability(20 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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