Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis: the PIMS trial.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Ashley Brown, Sam Norton, Whitney Scott, Barbara Barrett, Qazi Rahman, Lesley Catterall, Denise Middleton, Malgorzata 'Gosia' Kuran, Eli Silber, Rona Moss-Morris
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引用次数: 0

Abstract

Background: Multiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50-80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological interventions for addressing SDs in PwMS, although integrating them into routine care poses challenges. This protocol details the trial assessing the acceptability and feasibility of an eight-session, clinicians supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS).

Methods: This is a multicentre interventional two-arm randomized feasibility trial with a nested qualitative study to gather preliminary data about the intervention and the feasibility of conducting a full-scale trial. We aim to recruit 50 PwMS across three research sites in England's National Health Service (NHS). Participants will be randomised to either the PIMS intervention (comprised of 8 sessions: 6 self-led and 2-facilitator led over the course of 12 weeks) or psychosexual education (one appointment with a facilitator to discuss treatment options). Feasibility will be assessed by collecting descriptive data on recruitment and retention rates and willingness to be randomised according to Consolidated Standards of Reporting Trials (CONSORT) feasibility and pilot trial guidelines. Patient reported outcomes (e.g., measures of sexual functioning and distress, psychological functioning, and quality of life) will be measured at baseline and follow up 14-weeks after randomisation. We will also use a nested qualitative study will use inductive thematic analysis to identify barriers to engagement with and delivery of the intervention, and to make appropriate modifications to PIMS.

Discussion: The PIMS intervention will be the first integrated psychosexual intervention developed for people with Multiple Sclerosis in the UK. Assessing the feasibility of PIMS is an important first step to establishing future implementation and efficacy via a definitive randomised controlled trial.

Trial registration: This trial is registered at ISRCTN: 12202900 . Registration date: 28th February 2023; Retrospectively registered. IRAS identification: 305830. NIHR award reference: NIHR202006. Trial sponsorship: This trial is co-sponsored by South London and Maudsley NHS Foundation Trust and King's College London.

Contact:  slam-ioppn.research@kcl.ac.uk.

Protocol version:  2.0, 10th February, 2025.

Abstract Image

综合性心理干预治疗多发性硬化症患者性障碍的随机对照可行性试验方案:PIMS试验
背景:多发性硬化症(MS)是一种显著降低生活质量(QoL)的长期疾病。性困难(SDs)是常见的,但往往被忽视的症状,影响50-80%的MS (PwMS)患者。MS中SDs的出现是疾病过程、治疗和心理社会因素复杂相互作用的结果,导致生活质量进一步下降,对身体形象、人际关系和心理健康产生不利影响。尽管治疗选择有限,主要包括药物和物理治疗,但在心理干预方面有希望解决PwMS中的SDs,尽管将其整合到常规护理中存在挑战。本方案详细介绍了评估多发性硬化症(PIMS)患者接受性心理综合干预的可接受性和可行性的8期临床医生支持的试验。方法:这是一项多中心介入两组随机可行性试验,采用嵌套定性研究收集干预的初步数据和开展全面试验的可行性。我们的目标是在英格兰国家卫生服务(NHS)的三个研究地点招募50名PwMS。参与者将被随机分配到PIMS干预(包括8个阶段:6个自我主导和2个引导者主导,为期12周)或性心理教育(与引导者讨论治疗方案的一次预约)。将根据报告试验综合标准(CONSORT)可行性和试点试验指南,通过收集有关招聘和保留率以及随机分配意愿的描述性数据来评估可行性。患者报告的结果(例如,性功能和痛苦的测量,心理功能和生活质量)将在基线和随机化后14周随访时进行测量。我们还将使用嵌套定性研究,将使用归纳主题分析来确定参与和提供干预的障碍,并对PIMS进行适当的修改。讨论:PIMS干预将是英国第一个为多发性硬化症患者开发的综合性心理干预。评估PIMS的可行性是通过明确的随机对照试验确定未来实施和疗效的重要第一步。试验注册:该试验在ISRCTN: 12202900注册。报名日期:2023年2月28日;回顾注册。IRAS标识:305830。NIHR奖励参考号:NIHR202006。试验赞助:该试验由南伦敦和莫兹利NHS基金会信托基金和伦敦国王学院共同赞助。联系方式:slam-ioppn.research@kcl.ac.uk.Protocol版本:2.0,2025年2月10日。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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