The 'Nature Impact' feasibility study protocol: a mixed methods feasibility study of a group- and nature-based health intervention for adults experiencing mild to moderate anxiety, depression and/or stress.

IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Signe Salanson Jensen-Smidt, Louise Sofia Madsen, Lisa Gregersen Oestergaard, Dorthe Varning Poulsen, Knud Ryom, Nanna Holt Jessen
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引用次数: 0

Abstract

Background: Anxiety, depression and stress-related conditions are prevalent and growing public health challenges, impacting individuals' quality of life and placing significant strain on healthcare systems globally. These complex conditions rarely respond to a single mode of treatment, underscoring the importance of diverse and complementary approaches. Nature-based health interventions (NBHIs) represent one such perspective, offering novel opportunities to address mental health by engaging with natural environments. While international interest in NBHIs is growing, evidence on how these interventions can be systematically developed and implemented remains limited. The aim of this study protocol is to report the planned Nature Impact Feasibility Study.

Methods: The Nature Impact Feasibility Study is a one-armed, mixed methods feasibility study aiming to evaluate a complex, group-based NBHI developed using the Medical Research Council framework for complex interventions. The intervention will be conducted across three sites in Denmark: Glostrup outpatient clinic, Kolding and Silkeborg municipality centres. The intervention consists of group-based NBHI programmes delivered weekly over 10 consecutive weeks, facilitated by experienced health professionals. The feasibility evaluation will examine three core domains. These include (1) the implementation process, including fidelity, dose, reach, adaptations and acceptability; (2) mechanisms of change and (3) contextual factors influencing implementation and intervention processes. Data will be collected through participant observations, focus group interviews, registration forms and participant questionnaires assessing mental health outcomes and the participants' relationship to nature. Data will be analysed using a mixed methods convergent design. Quantitative and qualitative data will be analysed separately and then integrated thematically during interpretation.

Discussion: By reporting the study protocol for the Nature Impact Feasibility Study in advance, the project enhances transparency, allows for critical appraisal of the planned design and methods and strengthens the foundation for the subsequent feasibility evaluation and future large-scale trials. The Nature Impact Feasibility Study will provide valuable insight into delivering NBHIs for adults experiencing mild to moderate anxiety, depression and/or stress, while informing intervention refinement, outcome measures and future research aimed at investigating the potential of integrating NBHIs into existing practices for treating anxiety, depression and stress.

Trial registration: NCT06981000. Registered on March 13, 2025.

“自然影响”可行性研究方案:对经历轻度至中度焦虑、抑郁和/或压力的成年人进行基于群体和自然的健康干预的混合方法可行性研究。
背景:焦虑、抑郁和与压力相关的疾病是普遍存在的,也是日益严重的公共卫生挑战,影响着个人的生活质量,并给全球医疗保健系统带来了巨大压力。这些复杂的情况很少对单一的治疗模式有反应,强调了多样化和互补方法的重要性。基于自然的健康干预措施(NBHIs)代表了这样一种观点,为通过与自然环境接触来解决心理健康问题提供了新的机会。虽然国际上对国家卫生保健的兴趣日益增加,但关于如何系统地制定和实施这些干预措施的证据仍然有限。本研究方案的目的是报告计划中的自然影响可行性研究。方法:自然影响可行性研究是一项单臂、混合方法可行性研究,旨在评估使用医学研究委员会复杂干预框架开发的复杂的、基于群体的国家健康保险。干预措施将在丹麦的三个地点进行:Glostrup门诊诊所、Kolding和Silkeborg市政中心。干预措施包括由经验丰富的保健专业人员提供协助,在连续10周内每周开展以小组为基础的国家健康计划。可行性评估将审查三个核心领域。这些包括(1)实施过程,包括保真度、剂量、可及性、适应性和可接受性;(2)变化机制;(3)影响实施和干预过程的背景因素。数据将通过参与者观察、焦点小组访谈、登记表和参与者问卷收集,评估心理健康结果和参与者与自然的关系。数据将使用混合方法收敛设计进行分析。定量和定性数据将分别分析,然后在解释过程中按主题进行整合。讨论:通过提前报告自然影响可行性研究的研究方案,该项目提高了透明度,允许对计划设计和方法进行批判性评估,并为随后的可行性评估和未来的大规模试验奠定了基础。Nature Impact可行性研究将为为患有轻度至中度焦虑、抑郁和/或压力的成年人提供NBHIs提供有价值的见解,同时为干预改进、结果测量和未来研究提供信息,旨在调查将NBHIs纳入治疗焦虑、抑郁和压力的现有实践的潜力。试验注册:NCT06981000。于2025年3月13日注册。
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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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