对躁狂症患者进行非药物研究的可行性:基于扎根理论对“夜间渥太华太阳镜”研究的定性分析
The feasibility of conducting non-pharmacological research studies in participants with mania: a grounded theory qualitative analysis of the Ottawa Sunglasses at Night study.
作者信息
Yu Jessica, Burns Joseph K, Mikhail Eric, Solmi Marco, Hatcher Simon, Smith Andrew L, Robillard Rébecca, Nguyen Thanh, Edgar Nicole, Kendzerska Tetyana, Kaluzienski Mark, Bardell Andrea, Fiedorowicz Jess G
机构信息
Neurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Department of Psychiatry, University of Ottawa, Ottawa, Ontario, Canada.
出版信息
Int J Qual Stud Health Well-being. 2025 Dec;20(1):2540795. doi: 10.1080/17482631.2025.2540795. Epub 2025 Aug 9.
BACKGROUND
Feasibility concerns around non-pharmacological interventions can be a barrier against clinical research in individuals with mania.
METHODS
As part of a randomized controlled trial using blue-blocking vs lightly-tinted glasses, we interviewed participants who were hospitalized with mania and clinicians to gather insight on feasibility of recruitment and acceptability and implementation of tinted glasses according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework using a grounded theory approach. Semi-structured interviews with 24 participants and 10 clinicians were conducted.
RESULTS
The central theory of "research readiness for a dark therapy trial" was developed from six main themes identified from participant interviews: motivation, patient-centred approach, benefits of participating, research understanding, efficacy of intervention and challenges. The central theory of "supportive of blue-blocking glasses" was developed from five themes identified from clinician interviews: importance and benefits of clinical research, clinician-patient interactions, acceptability of research for participants, documentation and challenges.
DISCUSSION
This study identified themes from the experiences of participants and clinicians of the clinical trial that contribute to the feasibility and acceptability of blue-blocking glasses as an intervention for mania. The results of this qualitative study will inform implementation practices for clinical trials investigating non-pharmacological interventions for hospitalized individuals with mania and related acute psychiatric conditions which affect judgement.
背景
围绕非药物干预措施的可行性担忧可能会阻碍针对躁狂症患者的临床研究。
方法
作为一项使用蓝光阻挡眼镜与浅色眼镜的随机对照试验的一部分,我们采访了因躁狂症住院的参与者和临床医生,以运用扎根理论方法,根据RE-AIM(覆盖范围、有效性、采用率、实施情况和维持情况)框架,深入了解招募的可行性以及有色眼镜的可接受性和实施情况。我们对24名参与者和10名临床医生进行了半结构化访谈。
结果
“黑暗疗法试验的研究准备就绪”这一核心理论是从参与者访谈中确定的六个主要主题发展而来的:动机、以患者为中心的方法、参与的益处、对研究的理解、干预的效果以及挑战。“支持蓝光阻挡眼镜”这一核心理论是从临床医生访谈中确定的五个主题发展而来的:临床研究的重要性和益处、临床医生与患者的互动、参与者对研究的可接受性、记录以及挑战。
讨论
本研究从临床试验的参与者和临床医生的经历中确定了一些主题,这些主题有助于蓝光阻挡眼镜作为躁狂症干预措施的可行性和可接受性。这项定性研究的结果将为针对患有躁狂症及相关影响判断力的急性精神疾病的住院患者调查非药物干预措施的临床试验的实施实践提供参考。