NCT06513793

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

July 11, 2024

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    T0 (baseline), T1 (2 weeks) and T2 (4 weeks).

Secondary Outcomes (8)

  • 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).

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Waiting list

Interventions

Four-week intervention involving a self-help guidebook to improve mental wellbeing.

The Nature-based Intervention Condition: Roots and Shoots
Waiting listBEHAVIORAL

Four-week waiting list period involving treatment as usual.

Waiting list Control Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Visual or auditory impairments that may impede full engagement with the intervention.
  • Receiving formal psychological therapy in the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX4 4QG, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 31355340BACKGROUND
  • 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.

    PMID: 36624160BACKGROUND
  • 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.

    PMID: 37853074BACKGROUND
  • 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.

    PMID: 35897493BACKGROUND
  • 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.

    PMID: 23739312BACKGROUND
  • 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.

    PMID: 32628293BACKGROUND
  • 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.

    PMID: 32698802BACKGROUND

Related Links

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Matthew Owens, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes are recorded remotely by the participant, online using the Qualtrics platform.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 22, 2024

Study Start

June 2, 2024

Primary Completion

August 12, 2024

Study Completion

August 12, 2024

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations