Testing a Nature-based Social Intervention on Loneliness: the RECETAS-BCN Trial

NCT05488496 | Active Not Recruiting DMC

• 1 other identifier: 945095 BCN
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

RECETAS (Re-imagining 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 people to nature-based social activities through a group-based intervention. Background: Loneliness is the perception of feeling alone, even if surrounded by people. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness. RECETAS aims design and test a nature-based social intervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different cities: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If successful, this will provide an evidence-based approach for using social prescribing to address loneliness. Hypothesis: NBSI in vulnerable people suffering from loneliness is more effective than usual social and health care on reducing loneliness at post-intervention (10 weeks), 6- and 12-months follow up. Objectives: to assess the effectiveness of a 10-week NBSI on loneliness in vulnerable people in the area of Barcelona suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization. We will also explore the processes and perceived impacts of the intervention. A pilot study will be conducted (September-December 2022) before the RCT intervention (January 2023) with the aim to explore the feasibility and acceptability of the study procedures, including the primary and secondary outcome measures. 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. The recruitment will be coordinated and operationalized with Community Development Plans (CDP). Individuals will be recruited from primary care settings, third-sector organizations, community groups, and volunteer organisations who screen for loneliness. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI treatment and control arms. All of them will be asked to sign the informed consent form. The intervention model is adapted from the "Circle of Friends" methodology developed by the University of Helsinki (Jansson A, Pitkälä KH, 2021).

Conditions

Loneliness

Keywords

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

Outcome Measures

Primary Outcomes (2)

• De Jong Gierveld Loneliness Scale 11 item

  Loneliness

  Post-intervention (10 weeks)

• 15D instrument of health-related quality of life - 15D (Sintonen)

  Health-related quality of life

  Post-intervention (10 weeks)

Secondary Outcomes (24)

• De Jong Gierveld Loneliness Scale 11 item

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

• 15D instrument of health-related quality of life - 15D (Sintonen)

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

• Multidimensional scale of perceived social support (MSPSS)

  Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up

• Pain Brief Inventory

  Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up

• Perceived Stress Scale (PSS-10)

  Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will undergo the following steps: 1. Groups of 5-15 persons living in the same area. Two trained facilitators support the group dynamics fostering empowerment. 2. Each participant undergoes a one-to one personalized interview with the facilitator(s) to build the relationship and know participants' expectations and characteristics. 3. 9 sessions of group-based activities to promote peer support and accessibility and engagement with nature-based activities available in their area according to participant's preferences. A collaborative mapping of nature-based community assets will guide the group to the activities they want to approach and test.

Behavioral: Nature-based social intervention (NBSI), referred as Friends in Nature (FiN)

Control arm

ACTIVE COMPARATOR

The control arm will receive individually usual care (e.g. the existing social prescription as available) and a list of community resources based in nature in the area. Usual care is the appropriate comparison rather than a placebo for complex interventions.

Behavioral: Usual care + menu with nature-based activities

Interventions

Nature-based social intervention (NBSI), referred as Friends in Nature (FiN) BEHAVIORAL

The nature-based social prescribing is a multicomponent complex intervention applied by health or social care professionals as 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" methodology focused on loneliness (Jansson A, Pitkälä KH, 2021) adapted to the cultural context of Barcelona and the target population of adults living in urban socio-economic vulnerable areas. Nature-based activities are chosen by group participants through a co-created menu comprising all local resources in the area related to nature. Specifically, participants start with an individual one-to-one session and then they meet once a week for two hours 10 weeks. Each week, participants decide the nature-based activity they wish to conduct.

Also known as: Amistat a la natura, Amistad en la naturaleza, Friends in Nature

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:

• To be able to give informed consent in Catalan or Spanish and able to participate to the group dynamics and communicate in at least one of these languages.
• Aged 18 or over;
• Currently experiencing loneliness according to the screening question "'Do you suffer from loneliness?" answers "feels lonely 'sometimes, often or always'); can walk to the center independently; able to participate in a group dynamics;
• Willing to undergo study measurements.

You may not qualify if:

• Unable to go outdoors independently 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;
• Mild, moderate or severe cognitive decline (test de Pfeiffer \>2 fails);
• Any mental health disorder that might interfere with the group dynamics;
• Severe disease with poor prognosis \< 6 months.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Barcelona Institute for Global Health: collaborator
• Fundacio Salut i Envelliment UAB: collaborator
• Program on Substance Abuse, Public Health Agency, Government of Catalonia: collaborator

Study Sites (1)

UVic-UCC

Barcelona, Spain

Location

Related Publications (5)

• 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

• 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

• 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

• 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

• Jansson A, Pitkala KH. Editorial: Circle of Friends, an Encouraging Intervention for Alleviating Loneliness. J Nutr Health Aging. 2021;25(6):714-715. doi: 10.1007/s12603-021-1615-5. No abstract available.

  PMID: 34179921 BACKGROUND

Related Links

• website of the European Projecte RECETAS

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

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

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 4, 2022
• Study Start: March 1, 2023
• Primary Completion: August 2, 2024
• Study Completion: May 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)