NCT04738890已完成不适用
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
研究概览
简要总结
This study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).
详细描述
This study is a pilot randomised controlled trial (RCT) comparing adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA) with a treatment as usual control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 15) and at follow-up (week 23).
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
- 是
入选标准
- •Parents or caregivers who identify as having a child under the age of 18 with a food allergy
- •The allergy has been diagnosed by a qualified physician (e.g. GP or allergy specialist)
- •Mean score of >=2 on the FAQL-PB, indicating they are at least 'somewhat limited/troubled' by their child's allergy (Cohen et al., 2004).
- •Resident in the United Kingdom
- •Have access to email, a PC/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing
排除标准
- •They had consulted on the design and content of the intervention or study
- •They have already participated in a substantial mindfulness-based course
- •They are currently engaged or are planning to engage with another psychological intervention during the course of the study
- •They currently engage in regular mindfulness-based practice
- •They do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice
- •They have scores >19 on PHQ-8 (indicating 'severe' depressive symptom severity; Kroenke et al., 2009) or >15 on GAD (indicating 'severe' level of anxiety; Spitzer et al., 2006)
- •They have a problem with alcohol or recreational drug misuse
- •They have experienced thoughts about harming themselves or others in the last 12 months
- •They have been given a diagnosis of psychosis
- •They are currently experiencing high levels of distress and/or currently feeling particularly fragile
- •They have experienced a bereavement of someone close to them in the last year or are continuing to experience continuing grief in relation to losing someone further back in time
- •They have had traumatic experiences that they continue to be troubled by (including, but not limited to, receiving diagnosis of post-traumatic stress disorder)
- •They experience significant difficulty being in a group with other people.
- •NB: for further details re the FAQL-PB and PHQ-8, please see the outcome measures section.
结局指标
主要结局
Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
时间窗: Post intervention (week 15)
This measures quality of life in parents of children with food allergies producing a score between 17 and 119, with higher scores indicating a greater burden on the family.
次要结局
- Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)(Follow up (week 23))
- Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)(Post intervention (week 15))
- Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)(Follow up (week 23))
- Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8)(Post intervention (week 15))
- Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8)(Follow up (week 23))
- Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS)(Post intervention (week 15))
- Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS)(Follow up (week 23))
- Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)(Post intervention (week 15))
- Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)(Follow up (week 23))
- Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items(Post intervention (week 15))
- Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items(Post intervention (week 23))
- Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items(Post intervention (week 15))
- Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items(Post intervention (week 23))
研究者
研究点 (2)
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