The Effect of a Nature-based, Self-help Intervention on Mental Wellbeing
NCT ID: NCT06513793
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
47 participants
INTERVENTIONAL
2024-06-02
2024-08-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
The Nature-based Intervention: Roots and Shoots
The intervention, Roots and Shoots, consists of a printed, self-help guidebook that covers six main section and includes weekly, evidence-based activities, as well as additional online components. Designed as a short, four week course for improving low wellbeing, the guidebook incorporates elements of environmental psychology (e.g. forest bathing) with techniques and exercises informed by several psychological therapies and traditions. In the first section participants are provided with a comprehensive introduction to the course including nature and wellbeing psychoeducation. This is consistent with research that has highlighted the benefits of psychoeducation as an effective therapeutic approach for improving low mood in individuals with depression. The following four sections guide participants through a set of weekly activities including a habit tracker, psychological coping tool, nature contact tracker, mood and nature connection monitoring and a reflective writing exercise. The rationale for the weekly exercises was informed by behavioural activation principles, mindfulness, cultivation of habits, self-tracking of mood, nature exposure, compassion focused therapy and acceptance and commitment therapy techniques. Throughout Roots and Shoots participants will be signposted to an online webspace where they had access to additional digital resources including nature videos, meditations and breathing exercises. These activities draw on evidence showing the beneficial effects of virtual nature exposure, guided imagery, brief nature-based meditation and guided breathwork. Participants are also encouraged to reflect on their time spent engaging with nature and the guidebook activities.
Waiting list Control
Participants in the waiting list control arm will complete the assessments at the three time points: baseline (T0), at a 2-weeks (T1) and post-intervention (T2). At this point control arm participants will be offered the intervention and will receive a copy of the Roots and Shoots guidebook in the post and will be provided with full access to the additional online resources.
Analyses
Because this is a pilot RCT and is not designed to test the efficacy of the intervention, the primary focus will be on the feasibility and acceptability of the intervention. To this end the investigators will report on the feasibility of the intervention including recruitment to target, and proportion of participants returning the assessment surveys. The investigators will report the simple descriptive statistics on the feasibility and acceptability questions, as well as for the psychometric measures. In the analysis the investigators will follow the principle of intention to treat (ITT). That is, the investigators will not excluding any participants based on their level of engagement with the intervention. The investigators do not plan to remove outliers from any analysis.
The investigators will report the relative change in mean scores on the primary and secondary outcomes. The investigators will primarily report on mean differences, effect sizes and confidence intervals, not p-values. The investigators therefore will not be applying correction for multiple comparisons. No power calculation is required for this pilot study. The investigators will report means, standard deviations and 95% confidence intervals for the psychometric measures and report Hedge's g for estimates of effect size. To assist in the design of a potential future fully powered RCT, the investigators will carry out supplementary analyses. The investigators will carry out repeated measures analyses on the outcomes using mixed models or a general linear model. The investigators will also calculate Clinically Significant Change (CSC) to help assess the clinical significance of any improvement measured in the outcomes. The investigators will explore any clinical change on outcomes using graphs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The Nature-based Intervention Condition: Roots and Shoots
The intervention condition, Roots and Shoots, consists of a printed, self-help guidebook that incorporates weekly, evidence-based activities with the aim to improve mental wellbeing. The intervention is a short, four week course for improving low wellbeing and is informed by psychological theory, clinical psychology therapeutic principles and environmental psychology.
Roots and Shoots
Four-week intervention involving a self-help guidebook to improve mental wellbeing.
Waiting list Control Condition
Participants in the waiting list control group will complete the assessments at the three time points: baseline (T0), at a 2-weeks (T1) and post-intervention (T2). At this point control condition participants will be offered the intervention and will receive a copy of the Roots and Shoots guidebook in the post and will be provided with full access to the additional online resources.
Waiting list
Four-week waiting list period involving treatment as usual.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Roots and Shoots
Four-week intervention involving a self-help guidebook to improve mental wellbeing.
Waiting list
Four-week waiting list period involving treatment as usual.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Receiving formal psychological therapy in the last three months.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Exeter
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew Owens, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Exeter
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Exeter
Exeter, Devon, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bratman GN, Anderson CB, Berman MG, Cochran B, de Vries S, Flanders J, Folke C, Frumkin H, Gross JJ, Hartig T, Kahn PH Jr, Kuo M, Lawler JJ, Levin PS, Lindahl T, Meyer-Lindenberg A, Mitchell R, Ouyang Z, Roe J, Scarlett L, Smith JR, van den Bosch M, Wheeler BW, White MP, Zheng H, Daily GC. Nature and mental health: An ecosystem service perspective. Sci Adv. 2019 Jul 24;5(7):eaax0903. doi: 10.1126/sciadv.aax0903. eCollection 2019 Jul.
Fincham GW, Strauss C, Montero-Marin J, Cavanagh K. Effect of breathwork on stress and mental health: A meta-analysis of randomised-controlled trials. Sci Rep. 2023 Jan 9;13(1):432. doi: 10.1038/s41598-022-27247-y.
Owens M, Bunce H. The effect of brief exposure to virtual nature on mental wellbeing in adolescents. Sci Rep. 2023 Oct 18;13(1):17769. doi: 10.1038/s41598-023-44717-z.
Owens M, Bunce HLI. Nature-Based Meditation, Rumination and Mental Wellbeing. Int J Environ Res Public Health. 2022 Jul 26;19(15):9118. doi: 10.3390/ijerph19159118.
Tursi MF, Baes Cv, Camacho FR, Tofoli SM, Juruena MF. Effectiveness of psychoeducation for depression: a systematic review. Aust N Z J Psychiatry. 2013 Nov;47(11):1019-31. doi: 10.1177/0004867413491154. Epub 2013 Jun 5.
Uphoff E, Ekers D, Robertson L, Dawson S, Sanger E, South E, Samaan Z, Richards D, Meader N, Churchill R. Behavioural activation therapy for depression in adults. Cochrane Database Syst Rev. 2020 Jul 6;7(7):CD013305. doi: 10.1002/14651858.CD013305.pub2.
van der Watt ASJ, Odendaal W, Louw K, Seedat S. Distant mood monitoring for depressive and bipolar disorders: a systematic review. BMC Psychiatry. 2020 Jul 22;20(1):383. doi: 10.1186/s12888-020-02782-y.
Related Links
Access external resources that provide additional context or updates about the study.
Study group and participant webspace.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5412277
Identifier Type: -
Identifier Source: org_study_id