行为疗法治疗发作间期双相症状(稳定)的随机对照可行性试验研究方案。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Kim Wright, Fiona Warren, Sandra Bucci, Barnaby D Dunn, Steven Jones, Heather O'Mahen, Rod S Taylor, Antonieta Medina-Lara
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引用次数: 0

摘要

背景:在(轻度)躁狂和重度抑郁症发作之间,双相情感障碍患者可以经历持续的情绪低落或情绪不稳定,这些也可能作为循环胸腺障碍的一部分存在。这是一项针对发作间双相症状的适应性行为疗法(稳定)的II期评估。该研究旨在确定治疗和研究程序的可行性和可接受性,包括经济成分,为未来的最终试验提供信息。方法:患者将按1:1随机分配到常规治疗组(对照组)或常规治疗加稳定干预组(干预组)。随访点将在资格确认后的14周、30周和52周,以30周为主要终点。我们的目标是招募60名符合双相情感障碍诊断标准的个体,并报告在躁狂或严重抑郁发作之外的持续双相情感障碍症状(情绪低落或情绪不稳定)。可行性和可接受性将通过招募率和保留率、候选主要结果指标(PHQ9、ALS-SF、QoL)的完成率进行审查。BD和BRQ)以及参与者对其研究参与和治疗经验的反馈。如果满足以下标准,将表明进行最终试验:(i)参加试验被认为或可以足够安全;㈡招聘率表明,更大规模的招聘是可行的(在至少一个场址内每月至少招聘两名参与者,并在总体目标样本量未达到时制定缓解计划);(iii)对于候选主要结果测量,至少75%的参与者在30周时可获得随访数据,或55 - 74%的参与者有明确的改善计划。讨论:本研究是一项随机对照可行性试验,建立在稳定方法的初始病例系列基础上。研究结果将用于确定未来的确定试验是否可行,并完善研究程序和治疗方案。试验注册:ISRCTN18207465。2024年3月13日注册,https://www.isrctn.com/ISRCTN18207465。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A study protocol for a randomized controlled feasibility trial of behavioural therapy for interepisode bipolar symptoms (STABILISE).

A study protocol for a randomized controlled feasibility trial of behavioural therapy for interepisode bipolar symptoms (STABILISE).

Background: In between episodes of (hypo) mania and major depression, people with bipolar disorder can experience ongoing low mood or mood instability, and these may also be present as part of cyclothymic disorder. This is a phase II evaluation of an adapted form of behavioural therapy (STABILISE) for inter-episode bipolar symptoms. The study aims to establish the feasibility and acceptability of the therapy and research procedures, including an economic component, to inform a future definitive trial.

Methods: Patients will be randomised 1:1 to either Treatment as Usual (control arm) or Treatment as Usual plus STABILISE intervention (intervention arm). Follow up points will be at 14, 30 and 52 weeks post eligibility confirmation, with 30 weeks as the primary end point. We aim to recruit 60 individuals meeting diagnostic criteria for a Bipolar Spectrum Disorder, and reporting ongoing bipolar symptoms (low mood or mood instability) outside of a manic or severe depressive episode. Feasibility and acceptability will be examined through recruitment and retention rates, completion rates for the candidate primary outcome measures (PHQ9, ALS-SF, QoL.BD and BRQ) and feedback from participants on their experience of study participation and therapy. Proceeding to a definitive trial will be indicated if the following criteria are met: (i) trial participation is deemed, or can be made, sufficiently safe; (ii) recruitment rate indicates that larger-scale recruitment would be feasible (recruitment rate of at least two participants per month within at least one site, with mitigation plan if overall target sample size not met); (iii) for candidate primary outcome measure follow up data is available at 30 weeks from at least 75% of participants, or from between 55 and 74% with clear plan for improvement.

Discussion: This study is a randomised, controlled feasibility trial that builds on an initial case series of the STABILISE approach. The findings will be used to establish whether a future, definitive trial is feasible and to refine the research procedures and therapy protocol.

Trial registration: ISRCTN18207465. Registered 13th March 2024, https://www.isrctn.com/ISRCTN18207465 .

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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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