Testing a Nature-based Socila Intevention on Loneliness: the RECETAS-PRG Trial

NCT05522140 | Active Not Recruiting DMC

• 1 other identifier: 945095 PRG
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

RECETAS (Re-imagine Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an European project (H2020 No 945095) that aims to reduce loneliness by linking lonely pople to nature-based social actvitities through a group-based intervention. Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. RECETAS aims to design and test nature-based socila itervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different citites: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If succesful, this will provide an evidence-based approach for using social prescribing to address loneliness. Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization. A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself. Methods: The study design is a randomized controlled trial (RCT) including a process evaluation based on Medical health Council guidance, a nested qualitative study and a Health Economics evaluation. Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI tratment and control arms. All of them will be asked to sign the informed consent form.

Conditions

Loneliness

Keywords

social prescribing; social intervention; nature-based activities; mental health; wellbeing; prevention; nature-based therapy; complex intervention; community-based; urban health; loneliness

Outcome Measures

Primary Outcomes (2)

• De Jong Gierveld Loneliness Scale 11 item

  Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))

  Post-intervention (10 weeks)

• 15D instrument of health-related quality of life

  Change in health related quality of life. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.

  Post-intervention (10 weeks)

Secondary Outcomes (11)

• Psychological Wellbeing Scale by Routasalo et al. 2009

  From baseline to 3months, 6months, 12 months

• Clock drawing test

  From baseline to 3months, 6months, 12 months

• Instrumental Activities of Daily Living Scale

  From baseline to 3months, 6months, 12 months

• 15D instrument of health-related quality of life

  Baseline (before intervention), 6- and 12-months follow up

• De Jong Gierveld Loneliness Scale 11 item

  Baseline (before intervention), 6- and 12-months follow up

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will undergo following steps: 1. Groups of 5-15 persons, who lives in Prague. Two trained facilitators support the group dynamics forstering empowerment. 2. Each participant will undergo an individual session with the facilitator(s) aimed at building relationships and trust, and getting to know the expectations and characteristics of the participants. 3. 9 group activities with the aim to promote accessibility and engagement with the nature and outdoor activities available in their town. Collaborative mapping of nature-based community activities will direct the group to activities they want to approach and test.

Behavioral: Nature-based social intervention (NBIS)

Control arm

ACTIVE COMPARATOR

Participants randomly assigned to the control arm will receive usual care, which is a list of community resources in the city (Prague). Usual care is an appropriate comparison rather than placebo for complex interventions

Behavioral: Usual care + menu with nature based activities

Interventions

Nature-based social intervention (NBIS) BEHAVIORAL

Nature-based social prescribing is a multicomponent, multi-level, behaviorally based complex intervention applaied by facilitators after a specific training. It comprises: a psychosocial component and nature-based activities. The psychosocial component is adapted from the group dynamic of "Circle of Friends" methodolgy focused on loneliness(Jansson A, Pitkälä KH, 2021) adapted to the cultural context of Prague and the target population (partitipants) of adults who lives in Prague. Participants start with an individual session and then meet once a week for two hours for 10 weeks. At the first meeting together, participants select the nature-based activities they wish to conduct through a co-created menu.

Intervention arm

Usual care + menu with nature based activities BEHAVIORAL

Social prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give informed consent in Czech
• Older adults (60+) with a risk of social isolation and loneliness
• Currently experiencing loneliness according to the screening question "Do you suffer from loneliness?"
• Willing to undergo study measurement.

You may not qualify if:

• Unable to go outdoors due to poor mobility or severe diseases.
• Poor hearing or sight in case it prevents them to participate of the group dynamics and activities in the nature.
• Severe, moderate or mild cognitive decline.
• Any mental health disorders that might interfere with the group dynamics.
• Severe disease with poor prognosis \< 6 months.

Sponsors & Collaborators

• Vladimíra Dostálová: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (1)

Charles University

Prague, Czechia

Location

Related Publications (5)

• Litt, J. S., Coll-Planas, L., Sachs, A. L., Rochau, U., Jansson, A., Dostálová, V., … Pitkälä, K. H. (2024). Nature-based social interventions for people experiencing loneliness: the rationale and overview of the RECETAS project. Cities & Health, 8(3), 418-431. https://doi.org/10.1080/23748834.2023.2300207

  BACKGROUND

• Coll-Planas L, Carbo-Cardena A, Jansson A, Dostalova V, Bartova A, Rautiainen L, Kolster A, Maso-Aguado M, Briones-Buixassa L, Blancafort-Alias S, Roque-Figuls M, Sachs AL, Casajuana C, Siebert U, Rochau U, Puntscher S, Holmerova I, Pitkala KH, Litt JS. Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project. BMC Public Health. 2024 Jan 13;24(1):172. doi: 10.1186/s12889-023-17547-x.

  PMID: 38218784 BACKGROUND

• Vert C, Litt JS, Gascon M, Roque M, Maso-Aguado M, Opacin N, Garcia G, Jansson A, Cattaneo L, Bartova A, Briones-Buixassa L, Carbo A, Rautiainen LJ, Hidalgo L, Sachs A, Domenech S, Blancafort-Alias S, Holmerova I, Pitkala KH, Coll-Planas L. Evaluating the feasibility of "Friends in Nature," a complex nature-based social intervention to address loneliness and quality of life in six cities worldwide. Pilot Feasibility Stud. 2024 Nov 30;10(1):146. doi: 10.1186/s40814-024-01575-4.

  PMID: 39616375 BACKGROUND

• Sachs AL, Maso-Aguado M, Bach A, Opacin N, Hill N, Cattaneo L, Coll-Planas L, Johnson K, Hidalgo L, Daher C, Litt J, Bekessy S. Developing a new tool to capture the nature dose to reduce loneliness and improve quality of life. MethodsX. 2024 Sep 19;13:102969. doi: 10.1016/j.mex.2024.102969. eCollection 2024 Dec.

  PMID: 39385940 BACKGROUND

• Girdler NM. Air-gun injury to the face. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):137. doi: 10.1016/0030-4220(94)90133-3. No abstract available.

  PMID: 7936578 BACKGROUND

Related Links

• website of the European Projecte RECETAS

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Jill S Litt, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 30, 2022
• Study Start: March 27, 2023
• Primary Completion: February 26, 2025
• Study Completion: October 31, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)