Low Mental WellbeingNCT06513793
The Effect of a Nature-based, Self-help Intervention on Mental Wellbeing
A study testing Roots and Shoots and Waiting list in people with Low Mental Wellbeing, run by University of Exeter at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Mental Wellbeing
- What is being tested?
- Roots and Shoots and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2024to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Visual or auditory impairments that may impede full engagement with the intervention.
- Receiving formal psychological therapy in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed description
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
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
- Low Mental Wellbeing
- Being tested
- Roots and Shoots, Waiting list
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roots and ShootsBehavioural
Four-week intervention involving a self-help guidebook to improve mental wellbeing.
Waiting listBehavioural
Four-week waiting list period involving treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| The Nature-based Intervention Condition: Roots and Shoots | Experimental | 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. Receives: Behavioral: Roots and Shoots |
| Waiting list Control Condition | Active comparator | 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. Receives: Behavioral: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS).
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.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Secondary outcomes (8)
Patient Health Questionnaire (PHQ-8).
The Patient Health Questionnaire (PHQ-8) is an 8-item diagnostic tool and measure used for assessing the severity of depressive symptoms. Scores range from 0 to 24 and higher scores indicate higher severity of depressive symptoms.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Generalised Anxiety Disorder (GAD-7).
The Generalised Anxiety Disorder (GAD-7) is a 7-item measure that assesses anxious symptoms during the past 2 weeks. Scores range from 0 to 27 and higher scores indicate higher severity of anxiety symptoms.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Perceived Stress Scale (PSS4).
The Perceived Stress Scale (PSS4) is a four-item scale measuring perceived psychological stress in the last month. Scores range from 0 to 16 and higher scores indicate higher levels of perceived stress.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Ruminative Response Styles (RRS).
The Ruminative Response Styles (RRS) aims to measure ruminative tendency in response to low mood. The short version of the RRS is comprised of ten items, with two subscales for brooding and reflection. The investigators use only the Brooding subscale, consisting of five items, in this pilot. Scores range from 5 to 20 and higher scores indicate higher levels of rumination.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Five Factor Mindfulness Questionnaire (FFMQ15).
The Five Factor Mindfulness Questionnaire (FFMQ15) is a 15-item measure that assesses five aspects of mindfulness including observing, describing, acting with awareness, non-judging and non-reactivity to inner experience. Scores range from 1 to 75 and higher scores indicate higher levels of mindfulness.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Jenkins Sleep Scale (JSS).
The Jenkins Sleep Scale (JSS) measures common sleep disturbances symptoms seen in the general population, it contains four items that assess sleep problems over the past month. Scores range from 0 to 20 and higher scores indicate more sleep problems.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
The Nature Relatedness Questionnaire (NR6).
The Nature Relatedness Scale (NR6) is a six-item scale measuring the individual's sense of connection with the natural environment. Scores range from 6 to 35 and higher scores indicate stronger connectedness to nature.
Measured: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Acceptability and feasibility questions
Please indicate approximately how many days of the guidebook you completed? The guidebook activities were easy to do. The guidebook was easy to follow. The online activities were easy to do. The online activities were easy to follow. I would like the intervention to be longer than 4 weeks. 4 weeks was about the right length for the intervention. I would like the Intervention to be shorter than 4 weeks. Overall I enjoyed doing the Programme. I would come back and use the guidebook again in the future. The Roots \& Shoots Programme was helpful in improving my wellbeing. I would recommend the Roots \& Shoots Programme to a friend. The information in the guidebook was helpful. The habit wheel was helpful. The habit and mood tracker was helpful. The expressive writing was helpful. The honeycomb challenge was helpful. The coping tool was helpful. I found the nature videos helpful. I found the meditations helpful. I found the breathing exercises helpful.
Measured: T2 (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start2 Jun 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot randomised controlled trial with two arms; psychological intervention versus waiting list control. The control arm participants will be offered the intervention following the end of the waiting list period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Owens, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513793
- Sponsor's protocol ID
- 5412277
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31355340Fincham 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.
PubMed 36624160Owens 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.
PubMed 37853074Owens 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.
PubMed 35897493Tursi 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.
PubMed 23739312Uphoff 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.
PubMed 32628293van 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.
PubMed 32698802
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nature-based, Self-help Intervention on Mental Wellbeing
- ClinicalTrials.gov ID
- NCT06513793
- Acronym / sponsor ID
- 5412277
- Conditions
- Low Mental Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot randomised controlled trial with two arms; psychological intervention versus waiting list control. The control arm participants will be offered the intervention following the end of the waiting list period.
| Arm | Type | Receives |
|---|---|---|
| The Nature-based Intervention Condition: Roots and Shoots | Experimental | Behavioral: Roots and ShootsThe 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. |
| Waiting list Control Condition | Active comparator | Behavioral: Waiting listParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Visual or auditory impairments that may impede full engagement with the intervention.
- Receiving formal psychological therapy in the last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roots and ShootsFour-week intervention involving a self-help guidebook to improve mental wellbeing. | Behavioural | The Nature-based Intervention Condition: Roots and Shoots |
| Waiting listFour-week waiting list period involving treatment as usual. | Behavioural | Waiting list Control Condition |
Primary outcome
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS).
Time frame: 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.
8 secondary outcomes
Patient Health Questionnaire (PHQ-8).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Generalised Anxiety Disorder (GAD-7).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Perceived Stress Scale (PSS4).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Ruminative Response Styles (RRS).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Five Factor Mindfulness Questionnaire (FFMQ15).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Jenkins Sleep Scale (JSS).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
The Nature Relatedness Questionnaire (NR6).
Time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).
Acceptability and feasibility questions
Time frame: T2 (4 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 31355340Bratman 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.
- Background: PubMed 36624160Fincham 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.
- Background: PubMed 37853074Owens 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.
- Background: PubMed 35897493Owens 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.
- Background: PubMed 23739312Tursi 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.
- Background: PubMed 32628293Uphoff 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.
- Background: PubMed 32698802van 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.
- Study group and participant webspace.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Program Effectiveness, Program Implementation
Not yet recruiting
Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial
Metabolic Syndrome, Inactivity/Low Levels of Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Owens, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roots and Shoots and Waiting list in people with Low Mental Wellbeing, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS). (time frame: T0 (baseline), T1 (2 weeks) and T2 (4 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513793, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.