A Pilot and Feasibility Trial of a Group Mindfulness and Self-compassion Intervention for Young People Diagnosed With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline Psychological Distress at 6 time points
研究概览
简要总结
Young people with IBD face all the usual complexities of growing up, with the additional complications of having a chronic health condition, often recently diagnosed, which can have a detrimental impact on their mental health.
This research seeks to examine the potential effectiveness of a two-stage intervention for young people with IBD via a pilot feasibility trial. First, a mindfulness-based stress reduction (MBSR) group with a "Mindfulness based compassionate living" (MBCL) group delivered soon afterwards. Both interventions will be delivered online. MBSR aims to increase peoples awareness of their tendency to get caught up in thoughts and help them live in the present moment. Once an individual has achieved greater awareness of their thought processes, MBCL then aims to help individuals to become kinder to themselves, and less critical. We know from interview studies with young people with IBD that they can be harsh on themselves about how they are coping, and being harsh and critical can impact wellbeing. By targeting mindfulness and self-compassion we hope to demonstrate a positive impact on wellbeing, by reducing stress, anxiety and depression and improving quality of life (primary outcome measures) for young people with IBD and equip them with a mindfulness practice to use in the future as they continue to manage their IBD.
详细描述
Design: This study is designed as a pilot and feasibility trial, using a step-wedged design, and designed in line with CONSORT guidance. Pilot trials are used in advance of a larger future definitive randomised controlled trial (RCT) to focus on the development and refinement of the intervention, assess potential effectiveness, intervention acceptability and to determine whether a larger RCT is feasible. In step-wedged designs, all participants begin the study as 'control participants' and at regular 'steps' one group crosses from the control to the intervention condition, until all groups have completed the intervention. The step-wedged design is a pragmatic and financially viable design which reconciles the need for robust evaluations and logistical time constraints, as each participant acts as their own control. On conclusion of group participation, all participants will be invited to take part in one-to-one interviews with the lead researcher to discuss their experiences of MBSR+MBCL, to assess the acceptability of the intervention and inform future adaptations prior to larger trial.
Recruitment: Eligible and consenting participants will be identified in two ways. Firstly, by clinical staff at either Sheffield Teaching Hospital (NHS) or Sheffield Children's Hospital specialist IBD gastroenterology services and secondly, by poster, email or social media advertisements at the University of Sheffield and through relevant charitable organisations. Participants will be recruited on an ongoing basis and allocated to the next available group, or another, if the dates of the next group are not convenient.
Procedure: All consenting and eligible participants will meet with the lead researcher who will induct them into the trial and inform them of group allocation, and when they will commence the intervention. As in most psychological intervention trials, it will be impossible to blind participants to the interventions they are receiving. All outcome measures will be completed online via the Qualtrics platform.
Interventions (delivered online via video call): MBSR is an 8-week intervention consisting of 2.5 hour weekly sessions which involves the teaching and practice of formal mindfulness exercises, aimed at promoting the use of mindfulness in daily life for individuals experiencing stress, pain and/or illness. Participants are asked to engage in homework exercises which are intended to reinforce the techniques learnt each week. The intervention will aim to establish home practice and introduce self-compassion. MBCL is designed to be a follow-up intervention to a MBI. MBCL is a group intervention, also eight weeks in length and the sessions last 2.5 hours. The sessions contain a mixture of mindfulness practice, group discussion and didactic and interactive teaching. However, the content of the practices are different to traditional MBSR, focusing on turning towards suffering and developing a kind attitude to the self. Both MBSR and MBCL interventions will be taught by one of two accredited mindfulness teachers who have extensive experience in teaching MBIs, and who will complete the MBCL teaching training prior to the trial commencing. Adherence to the interventions will be measured by attendance at the group sessions and by participants home practice diaries. Fidelity to the interventions will be evaluated in line with guidance from previous studies and the application of a fidelity checklist.
Control condition: Prior to entering the intervention phase of the study, all individuals will begin in the control condition which consists of the routine medical monitoring and psychosocial support provided by gastroenterologists and IBD nurse specialists. Participants will be requested not to change their medication during the study, if at all possible, and to refrain from beginning any other psychological interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16-25
- •Confirmed diagnosis of IBD
- •Be able to verbally communicate and write in English
- •Be able to give informed consent
- •Be able to engage in light exercise (required for the intervention)
- •Be able to commit to home practice
排除标准
- •Major psychiatric illness
- •Active alcohol/drug dependency
- •Scheduled for major surgery in the next 3 months
- •Participation in any other IBD intervention studies within the last 6 months
- •Prescribed antidepressants within the last 3 months.
结局指标
主要结局
Change from Baseline Psychological Distress at 6 time points
时间窗: When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls.
Psychological distress will be measured using 21-item The Depression Anxiety Stress Scales-Short Form (DASS-21). Participants will rate themselves on items such as, "I found myself feeling agitated, according to a 4-point Likert scale, higher scores indicating greater psychological distress. The measure yields three subscale scores: depression (range from 0 to 42), anxiety (range from 0 to 42), stress (range from 0 to 42), and an overall psychological distress total score (range from 0 to 126). The total score is computed by summing the subscale scores.
Change from Baseline Quality of Life at 6 time points
时间窗: When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls
Quality of life will be measured using the Inflammatory Bowel Disease Questionnaire (IBDQ). Participants rate themselves on items such as, "how frequent have your bowel movements been during the last two weeks?" according to seven point scales, lower scores indicating poorer health status in all subscales. The IBDQ is a 32-item self-report measure assessing quality of life, yielding four subscale scores: bowel symptoms (ranging from 10 to 70), systemic symptoms (range 5 to 35), emotional function (range 12 to 84) and social function (range 5 to 35) and a global subjective health status score calculated by summing the subscale scores (range from 32 to 224).
Change from Baseline Disease Activity at 3 time points
时间窗: 8-weeks, 20 weeks, and 59 weeks.
Disease activity will be measured by faecal calprotectin levels, a biological measure of disease activity. Calprotectin is activated when inflammation occurs (whatever the cause of that may be) and thus can be used as a diagnostic indicator. The concentration of calprotectin relates directly to the severity of the inflammation.
次要结局
- Change from Baseline Mindfulness at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Sleep Disturbance at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Pain Interference and Intensity at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Coping Style at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Self-Compassion at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Fatigue at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)
- Change from Baseline Self-Efficacy at 6 time points(When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls)