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NCT Number: NCT05488496

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVic-UCC

Barcelona, Spain

About this study

RECETAS (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is a project that addresses loneliness and the role of nature-based social prescription (NBSP) to reduce it. This project has received funding from the European Union's Horizon 2020 research and innovation under grant agreement No 945094. More information at: https://recetasproject.eu/

Background: Loneliness is the perception of feeling alone, even if surrounded by people. It is a growing public health concern due to its impact on morbidity and mortality, being as dangerous as smoking or obesity: it reduces people's lifespan, and it is associated with chronic diseases as well as mental health symptoms. In Europe, 30 million European adults frequently felt lonely. Social prescription is a non-medical community referral approach to connect individuals with community resources to support wellbeing. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness. We will 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.

Justification: NBSI in urban areas can improve health and mental well-being and reduce loneliness. Investments in nature-based solutions and green infrastructure can be harnessed for health and wellbeing even in times of health emergencies (covid-19). NBSI offers a novel socio-environmental innovation to reduce loneliness by creating the social infrastructure needed to support social and community cohesion.

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 and to explore the processes and perceived impacts of NBSI in vulnerable people suffering from loneliness in the area of Barcelona. The specific objective is to assess the effectiveness of a 10-week NBSI on loneliness in vulnerable people suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.

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 corresponds to a randomized controlled trial (RCT). The RCT will include a process evaluation based on Medical Health Council guidance, a nested qualitative study and a Health Economics evaluation. Therefore, overall, the RCT will use a mixed-method approach collecting quantitative information to assess the main outcomes and qualitative methods to explore lived experiences of participants and professionals. ISGlobal coordinates the overall RECETAS project, UVIC-UCC leads the implementation of the RECETAS-BCN and is responsible for the intervention, assessments, process evaluation and qualitative study. FSIE-UAB is responsible for the recruitment and data analysis. The Public Health Agency of Catalonia is involved and provides support to RECETAS-BCN.

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 (158 each): NBSP intervention arm and control arm. All of them will be asked to sign the informed consent form.

Participants are randomly assigned to the intervention or control arm after the baseline assessment.

The intervention is a theory-informed, multicomponent, multi-level, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. The intervention model is adapted from the "Circle of Friends" methodology developed by the University of Helsinki by Pitkälä KH et al. It consists in: a) individualized session with facilitators (one-to-one interview), b) group-based program (5-15 people) for 9 sessions, once a week, including nature-based activities in the area chosen by the participants. Control group participants will receive usual care, and a list of nature-based resources available in their area.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Amistat a la natura, Amistad en la naturaleza, Friends in Nature

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.

Primary outcomes

  1. De Jong Gierveld Loneliness Scale 11 item

    Time frame: Post-intervention (10 weeks)

    Loneliness

  2. 15D instrument of health-related quality of life - 15D (Sintonen)

    Time frame: Post-intervention (10 weeks)

    Health-related quality of life

Secondary outcomes

  1. De Jong Gierveld Loneliness Scale 11 item

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

    Loneliness

  2. 15D instrument of health-related quality of life - 15D (Sintonen)

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

    Health-related quality of life

  3. Multidimensional scale of perceived social support (MSPSS)

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

    Perceived Social Support

  4. Pain Brief Inventory

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

    Pain

  5. Perceived Stress Scale (PSS-10)

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

    Stress

  6. EURO-QOL 5D-5L

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

    Quality of Life scale to assess cost-effectiveness

  7. ICEpop CAPability measure for Adults (ICECAP-A)

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

    self-report measure of capability wellbeing for adults

  8. Satisfaction with Life scale (SWLS)

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

    Satisfaction with Life scale as part of Wellbeing scales

  9. Spanish Subjective Happiness Scale

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

    Subjective Happiness Scale as part of Wellbeing scales

  10. Spanish adaptation of the Flourishing Scale Spanish adaptation of the Flourishing Scale

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

    Flourishing Scale as part of Wellbeing scales

  11. Cantril Ladder

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

    Wellbeing assessment

  12. Use of health and social services Use of health and social services retrieved from registers

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

    Retrieved from electronic medical records and self reported

  13. Lubben Social Network Scale-6

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

    Social interaction

  14. Club/association participation

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

    Social interaction

  15. Questions on distance social relations adapted from adhoc questions asked by K. Pitkala team (Helsinki)

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

    Social interaction

  16. PHQ-9 Patient health questionnaire

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

    Affect/Depression

  17. General anxiety disorder (GADS - 7)

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

    Anxiety

  18. SPANE: Scale of positive and negative experience

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

    Emotions

  19. The 6-item neighborhood attachment scale (NAS)

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

    Neighborhood

  20. Neighborhood aesthetics

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

    Neighborhood

  21. Nature Connection Index (NCI)

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

    Nature dose

  22. The International Physical Activity Questionnaires (IPAQ).

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

    Physical activity

  23. Intrinsic motivation Inventory (IMI)

    Time frame: During intervention (4 week) and Post-Intervention (10 weeks)

    Participants subjective experience related to a target activity

  24. Relatedness to Others in Physical Activity Scale (ROPAS)

    Time frame: During the intervention (4 week), Post-intervention (10 weeks), 6- and 12-months follow up.

    Social support

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Collaborators

  • Barcelona Institute for Global Health
  • Fundacio Salut i Envelliment UAB
  • Program on Substance Abuse, Public Health Agency, Government of Catalonia

Registry information

Official study title

Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Barcelona - a Randomized Controlled Trial

Acronym: RECETAS-BCN

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 4, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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