Wright Kim, Warren Fiona, Bucci Sandra, Dunn Barnaby D, Jones Steven, O'Mahen Heather, Taylor Rod S, Medina-Lara Antonieta
Department of Psychology, University of Exeter, Exeter, UK.
Exeter Clinical Trials Unit, University of Exeter School, Exeter, UK.
Pilot Feasibility Stud. 2025 Jul 10;11(1):97. doi: 10.1186/s40814-025-01678-6.
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.
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.
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.
ISRCTN18207465. Registered 13th March 2024, https://www.isrctn.com/ISRCTN18207465 .
在双相情感障碍患者的轻躁狂发作和重度抑郁发作期间，他们可能会持续情绪低落或情绪不稳定，这些症状也可能是环性心境障碍的一部分。这是一项针对发作间期双相情感障碍症状的适应性行为疗法（STABILISE）的II期评估。该研究旨在确定该疗法及研究程序（包括经济部分）的可行性和可接受性，为未来的确定性试验提供依据。
患者将按1:1随机分为常规治疗组（对照组）或常规治疗加STABILISE干预组（干预组）。随访时间点为符合入选标准后的14周、30周和52周，以30周作为主要终点。我们的目标是招募60名符合双相情感障碍谱系障碍诊断标准、并报告在躁狂或重度抑郁发作之外存在持续性双相情感障碍症状（情绪低落或情绪不稳定）的个体。可行性和可接受性将通过招募和保留率、候选主要结局指标（PHQ9、ALS-SF、QoL.BD和BRQ）的完成率以及参与者对参与研究和治疗体验的反馈来进行评估。如果满足以下标准，则表明可以进行确定性试验：（i）试验参与被认为或能够被证明足够安全；（ii）招募率表明大规模招募是可行的（至少一个研究点每月至少招募两名参与者，若未达到总体目标样本量则有缓解计划）；（iii）对于候选主要结局指标随访数据，至少75% 的参与者在30周时可获得，或在55%至74%的参与者中可获得且有明确的改进计划。
本研究是一项随机对照可行性试验，基于STABILISE方法的初始病例系列展开研究。研究结果将用于确定未来的确定性试验是否可行，并完善研究程序和治疗方案协议。
ISRCTN18207465。于2024年3月13日注册，https://www.isrctn.com/ISRCTN18207465 。
