The Effect of a Nature-based, Self-help Intervention on Mental Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS).
研究概览
简要总结
The goal of this pilot randomised controlled trial is to test the feasibility of a brief nature-based self-help psychological intervention for low mental wellbeing. The investigators want to learn whether the intervention is likely to help improve mental wellbeing and whether it is acceptable to participants. Participants will be members of the public in the United Kingdom (UK) with low mental wellbeing and the intervention lasts for four weeks.
The main questions it aims to answer are:
Will participants' mental wellbeing improve after the intervention, relative to participants in a waiting list arm.
Will participants find the intervention useful and acceptable to do?
Participants will:
Complete baseline questionnaires on demographic information and on several areas linked to wellbeing.
Complete further questionnaires on wellbeing after 2 weeks and 4 weeks. Complete a questionnaire on their experience of the intervention at 4 weeks. Receive and complete a self-guided booklet and link to a webspace to complete activities that are informed by psychological principles.
Receive the intervention after four weeks if they were allocated to the waiting list arm first.
详细描述
This study tests a brief nature-based psychological intervention for low mental wellbeing. This is a parallel groups waiting list control pilot randomised controlled trial (RCT). This a United Kingdom (UK) based pilot study and has the primary aim of assessing the acceptability and feasibility of the intervention. The pilot will assess the potential for the intervention to improve mental wellbeing but the efficacy of the intervention will be formally tested in a future powered RCT.
This RCT will compare a novel self-help guidebook called 'Roots and Shoots', which was designed to deliver a nature-based intervention for improving low wellbeing, against a waiting list control arm. Eligible participants will be randomly allocated to trial arm (1:1) using random permuted blocks, using the online randomisation service sealedenvelope.com. This is an automated process that ensures randomisation is not influenced by the researchers and prevents selection bias. At baseline (T0), 2-weeks (T1), and 4-weeks (T2) self-report assessments will be collected remotely using the online survey platform, Qualtrics®. Ethical approval was granted by the University of Exeter Psychology Ethics Committee prior to starting the study (Application ID: 5412277).
Participants will be recruited through opportunity sampling using recruitment methods including social media (e.g. Facebook, X), emails, newsletters and printed posters. Participants will be signposted to a brief screening survey in the first instance to check the eligibility criteria. Eligible participants will be contacted via email by a member of the research team to notify them of their eligibility status and confirm their availability to participate in the study. Following confirmation, participants will then be randomly assigned (1:1) to receive the intervention or be placed on a waiting list. Participants will be informed of this outcome by email. Given the nature of the intervention and study design, blinding of the participants is not possible. Participants will receive and read the participant information sheet (PIS) and provide informed consent before commencing the study. Once informed consent has been obtained, all participants will complete a series of baseline measures (T0) prior to starting the intervention or waiting list period. Following receipt of the guidebook, sent to the participant's postal address, participants assigned to the intervention group will be asked to complete the weekly activities and engage with additional online resources housed on the companion website (rowantree.uk).
All participants will be asked to complete a battery of measures at a 2-week interval (T1) and immediate post-intervention, at week 4 (T2). Participants in both the intervention and waiting list control group will complete the same set of online questionnaires at all three timepoints (T0, T1, T2), with the exception of additional feasibility and acceptability questions included in the final survey (T2) for participants in the intervention arm. All measures will be presented to participants in a fixed order and housed in the online distribution platform Qualtrics®. After completion of final survey (at 4-weeks) all participants will receive debrief information which includes the study aims, researcher contact details and signposting for further support and mental health services.
Trial Arms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes are recorded remotely by the participant, online using the Qualtrics platform.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must score 22 or less on the SWEMWBS scale-indicating low wellbeing-to facilitate clearer assessment of the intervention's consequence on such a measure.
- •Participants must be 18+ to take part in the study,
- •Participants must have sufficient understanding of the English language, to be able to fully comprehend the measures and intervention tasks, which at present are limited in translation due to methodological constraints.
排除标准
- •Visual or auditory impairments that may impede full engagement with the intervention.
- •Receiving formal psychological therapy in the last three months.
结局指标
主要结局
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS).
时间窗: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
The Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS) is a 7-item unidimensional self-report measure that captures social, eudaimonic and hedonic dimensions of mental wellbeing. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.
次要结局
- Patient Health Questionnaire (PHQ-8).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Generalised Anxiety Disorder (GAD-7).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Perceived Stress Scale (PSS4).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Ruminative Response Styles (RRS).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Five Factor Mindfulness Questionnaire (FFMQ15).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Jenkins Sleep Scale (JSS).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- The Nature Relatedness Questionnaire (NR6).(T0 (baseline), T1 (2 weeks) and T2 (4 weeks).)
- Acceptability and feasibility questions(T2 (4 weeks).)