NCT02794376已完成不适用
Mindfulness for Irritable Bowel Syndrome
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
- 67
- 主要终点
- Change in IBS symptom Severity (GSRS - IBS)
研究概览
简要总结
This study investigates the effectiveness of a 6 week mindfulness intervention in reducing symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment. Participants will be randomly allocated to an immediate treatment group and a waiting list control group.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Diagnosed with IBS by Gastroenterologist or General Practioner (GP), meeting Rome III criteria for IBS, symptom onset at least 6 months prior to inclusion, discomfort or pain at least 2-3 days per month
- •Participants speaks English fluently or at a native level
- •Participant has normal or corrected to normal vision
排除标准
- •Participant has insufficient manual dexterity for the computerized tasks
- •Severe Diagnostic and Statistical Manual (DSM) Axis I or II psychiatric disorder (diagnosis of dementia, amnesia, delirium, a dissociative disorder, a personality disorder, schizophrenia or any other psychotic disorder, a substance-related or induced disorder (such as alcoholism), attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), primary diagnosis of obsessive compulsive disorder (OCD), current suicidality, regular non-suicidal self-injury.
- •Recent bereavement (within one year)
- •GI diagnosis other than IBS (IBD, coeliac disease, another FGID)
- •Pregnancy
- •No access to the internet
- •Prior participation in an 8-week mindfulness course (MBSR, MBCT) or any other structured mindfulness training. Prior participation in Vipassana meditation courses. Regular meditation practice (meditating more than once per month).
- •Not able or unwilling to commit to amount of practice (sessions and home practice).
- •Participant is currently enrolled in another IBS treatment study (psychological or pharmacological).
研究组 & 干预措施
Immediate Treatment Group
Experimental
Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.
干预措施: Mindfulness Based Cognitive Therapy (MBCT) (Behavioral)
Delayed Treatment Group
Other
Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
干预措施: Mindfulness Based Cognitive Therapy (MBCT) (Behavioral)
Delayed Treatment Group
Other
Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
干预措施: Waiting Period (Behavioral)
结局指标
主要结局
Change in IBS symptom Severity (GSRS - IBS)
时间窗: Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Self-Report Questionnaire
次要结局
- Baseline levels of Thought Suppression (WBSI)(Baseline)
- Baseline levels of Rumination (RRS)(Baseline)
- Changes in IBS catastrophizing (GI-Cognitions Questionniare)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Attention to Health Threat (Dot-probe)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Change in IBS symptom Severity (GSRS - IBS) at Follow up(Baseline, Follow up (one month after the post assessment))
- Changes in IBS quality of Life (IBS-QOL)(Baseline, (Follow up one month after the post assessment))
- Changes in Positive and Negative Emotions (PANAS)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Mindfulness (FFMQ-short)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Shame Identification (IAT)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Visceral Anxiety Sensitivity (VSI)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Attentional Control (ANT)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Shame Association (SRET)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Changes in Illness Identification (IAT)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
- Baseline levels of Social Anxiety (SIAS-SPS)(Baseline)
- Baseline levels of Alexithymia (TAS-20)(Baseline)
- Baseline levels of Somatosensory Amplification (SSATS)(Baseline)
- Changes in Psychological Distress (DASS)(Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention))
研究者
相似试验
撤回
不适用
Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols DietIrritable Bowel Syndrome (IBS)NCT05630703Wake Forest University Health Sciences30
已完成
不适用
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey DataIrritable Bowel SyndromeNCT00880256Seattle Institute for Biomedical and Clinical Research93
已完成
不适用
Mindfulness vs. Support Groups for Irritable Bowel SyndromeIrritable Bowel SyndromeNCT00680693University of North Carolina, Chapel Hill75
已完成
不适用
Meditation and Yoga for Irritable Bowel SyndromeYogaMeditationIrritable Bowel SyndromeNCT04302623University of Calgary79
已完成
不适用
Mindfulness-Based Eating in Patients With Irritable Bowel SyndromeAbdominal PainIBSIrritable Bowel SyndromeNCT02681666University of Miami20