Dainty Andrew David, Fox Mark, Lewis Nina, Hunt Melissa, Holtham Elizabeth, Timmons Stephen, Kinsella Philip, Wragg Andrew, Callaghan Patrick
Nottingham Digestive Disease Centre Biomedical Research Unit and School of Health Sciences, University of Nottingham, Nottingham, UK.
Functional GI Diagnostics Laboratory, Division of Gastroenterology and Hepatology, Centre for Reflux and Swallowing Disorders, University Hospital, Zürich, Switzerland.
BMJ Open. 2014 Jun 17;4(6):e005262. doi: 10.1136/bmjopen-2014-005262.
Irritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic.
A mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis.
This study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee.
83683687 (http://www.controlled-trials.com/ISRCTN83683687).
肠易激综合征(IBS)的特征是出现腹痛、便秘、腹泻和腹胀等症状。这些症状会影响与健康相关的生活质量,导致医疗服务利用过度,给医疗系统带来沉重负担。IBS背后的某些机制可以用生物心理社会模型来解释,该模型适合采用认知行为疗法(CBT)等技术进行心理治疗。虽然目前的证据支持对这类患者进行CBT干预,但在英国医疗系统中获得这些治疗仍存在问题。
一项混合方法可行性随机对照试验将用于评估在二级护理胃肠诊所开展低强度、由护士提供指导的自助干预的可行性。总共60名参与者将被分配到四种治疗条件中,包括:由完全合格的认知行为治疗师提供的高强度CBT、由注册护士提供的低强度指导自助、无治疗师支持的仅自助以及常规治疗对照条件。将对研究各干预组的参与者进行访谈,以确定在临床实践环境中实施CBT干预的潜在障碍和促进因素。定量数据将仅使用描述性统计进行分析。定性数据将使用分组主题分析进行分析。
本研究将提供有关在二级护理胃肠诊所由护士提供CBT干预可行性的重要信息。本研究期间收集的数据在规划实质性试验时也将提供有用信息,并将在资助机构考虑对实质性试验资金进行投资时提供帮助。诺丁汉二号研究伦理委员会对本研究给予了有利意见。
ISRCTN:83683687(http://www.controlled-trials.com/ISRCTN83683687)