LonelinessRECETAS-BCNNCT05488496
Testing a Nature-based Social Intervention on Loneliness: the RECETAS-BCN Trial
A study testing Nature-based social intervention (NBSI), referred as Friends in Nature (FiN) in people with Loneliness, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Nature-based social intervention (NBSI), referred as Friends in Nature (FiN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Barcelona - a Randomized Controlled 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.
Read more
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).
Read the detailed description
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.
- Conditions
- Loneliness
- Being tested
- Nature-based social intervention (NBSI), referred as Friends in Nature (FiN), Usual care + menu with nature-based activities
- Keywords
- social prescription, nature-based therapy, mental health, complex intervention, community-based, wellbeing, prevention, urban health, loneliness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based social intervention (NBSI), referred as Friends in Nature (FiN)Behavioural
Also called Amistat a la natura, Amistad en la naturaleza, Friends in Nature
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.
Usual care + menu with nature-based activitiesBehavioural
Social prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual care + menu with nature-based activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
De Jong Gierveld Loneliness Scale 11 item
Loneliness
Measured: Post-intervention (10 weeks)
15D instrument of health-related quality of life - 15D (Sintonen)
Health-related quality of life
Measured: Post-intervention (10 weeks)
Secondary outcomes (24)
De Jong Gierveld Loneliness Scale 11 item
Loneliness
Measured: Baseline (before intervention), 6- and 12-months follow up
15D instrument of health-related quality of life - 15D (Sintonen)
Health-related quality of life
Measured: Baseline (before intervention), 6- and 12-months follow up.
Multidimensional scale of perceived social support (MSPSS)
Perceived Social Support
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Pain Brief Inventory
Pain
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Perceived Stress Scale (PSS-10)
Stress
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
EURO-QOL 5D-5L
Quality of Life scale to assess cost-effectiveness
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
ICEpop CAPability measure for Adults (ICECAP-A)
self-report measure of capability wellbeing for adults
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Satisfaction with Life scale (SWLS)
Satisfaction with Life scale as part of Wellbeing scales
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Spanish Subjective Happiness Scale
Subjective Happiness Scale as part of Wellbeing scales
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Spanish adaptation of the Flourishing Scale Spanish adaptation of the Flourishing Scale
Flourishing Scale as part of Wellbeing scales
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Cantril Ladder
Wellbeing assessment
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Use of health and social services Use of health and social services retrieved from registers
Retrieved from electronic medical records and self reported
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Lubben Social Network Scale-6
Social interaction
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Club/association participation
Social interaction
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Questions on distance social relations adapted from adhoc questions asked by K. Pitkala team (Helsinki)
Social interaction
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
PHQ-9 Patient health questionnaire
Affect/Depression
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
General anxiety disorder (GADS - 7)
Anxiety
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
SPANE: Scale of positive and negative experience
Emotions
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The 6-item neighborhood attachment scale (NAS)
Neighborhood
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Neighborhood aesthetics
Neighborhood
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Nature Connection Index (NCI)
Nature dose
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The International Physical Activity Questionnaires (IPAQ).
Physical activity
Measured: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Intrinsic motivation Inventory (IMI)
Participants subjective experience related to a target activity
Measured: During intervention (4 week) and Post-Intervention (10 weeks)
Relatedness to Others in Physical Activity Scale (ROPAS)
Social support
Measured: During the intervention (4 week), Post-intervention (10 weeks), 6- and 12-months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Mar 2023
- Primary completion2 Aug 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Barcelona Institute for Global Health, Fundacio Salut i Envelliment UAB, Program on Substance Abuse, Public Health Agency, Government of Catalonia
- Responsible party
- Sponsor
- Investigators
- Jill S Litt, PhD, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488496
- Sponsor's protocol ID
- 945095 BCN
- Acronym
- RECETAS-BCN
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39385940Vert 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.
PubMed 39616375Coll-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.
PubMed 38218784Litt, 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
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.
PubMed 34179921Papon V, Jahn B, Sroczynski G, Litt JS, Coll-Planas L, Maso-Aguado M, Arvandi M, Navarro JS, Kuchin I, Puntscher S, Siebert U, Rochau U. Comparative effectiveness of nature-based social prescribing to alleviate loneliness in Spain: a decision analysis informed by the RECETAS trial. Front Psychol. 2026 Oct 8;17:1891830. doi: 10.3389/fpsyg.2026.1891830. eCollection 2026.
PubMed 42923291Coll-Planas L, Maso-Aguado M, Briones-Buixassa L, Morato A, Mendez S, Carbo A, Fuente-Vidal A, Olivella-Cirici M, Casajuana Kogel C, Bartova A, Cattaneo L, Jansson AH, Kolster A, Novotna B, Opacin N, Papon V, Puntscher S, Rautiainen LJ, Rochau U, Blancafort-Alias S, Daher C, Bekessy S, Acurio-Paez D, Garcia Velez GE, Holmerova I, Johnson K, Segura LG, Siebert U, Pitkala KH, Sanz S, Litt JS. Effectiveness of a nature-based social prescribing intervention on loneliness and health-related quality of life among vulnerable urban adults (RECETAS-BCN): an observer-blinded randomised controlled trial. Lancet Reg Health Eur. 2026 Aug 18;69:101821. doi: 10.1016/j.lanepe.2026.101821. eCollection 2026 Oct.
PubMed 42662493Papon V, Puntscher S, Maso-Aguado M, Arvandi M, Jahn B, Jones M, Beardmore A, Olivella-Cirici M, Briones-Buixassa L, Coll-Planas L, Litt JS, Siebert U, Rochau U. Evaluating the social return on investment of nature-based social prescribing to alleviate loneliness: a randomized controlled trial in Barcelona. Front Public Health. 2026 May 25;14:1774155. doi: 10.3389/fpubh.2026.1774155. eCollection 2026.
PubMed 42267287Papon V, Puntscher S, Arvandi M, Jahn B, Litt JS, Coll-Planas L, Maso-Aguado M, Pitkala KH, Laakkonen ML, Roitto HM, Holmerova I, Bartova A, Jones M, Drummond M, Siebert U, Rochau U. Protocol for the health economic evaluation of nature-based social prescribing against loneliness alongside the RECETAS trials. BMC Public Health. 2026 May 9;26(1):2001. doi: 10.1186/s12889-026-27698-2.
PubMed 42106778
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Barcelona - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05488496
- Acronym / sponsor ID
- RECETAS-BCN / 945095 BCN
- Conditions
- Loneliness
- Keywords
- social prescription, nature-based therapy, mental health, complex intervention, community-based, wellbeing, prevention, urban health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Barcelona Institute for Global Health, Fundacio Salut i Envelliment UAB, Program on Substance Abuse, Public Health Agency, Government of Catalonia
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 4 Aug 2022 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Nature-based social intervention (NBSI), referred as Friends in Nature (FiN)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. |
| Control arm | Active comparator | Behavioral: Usual care + menu with nature-based activitiesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Nature-based social intervention (NBSI), referred as Friends in Nature (FiN)Also: Amistat a la natura, Amistad en la naturaleza, Friends in NatureThe 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. | Behavioural | Intervention arm |
| Usual care + menu with nature-based activitiesSocial prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area. | Behavioural | Control arm |
Primary outcome
De Jong Gierveld Loneliness Scale 11 item
Time frame: Post-intervention (10 weeks)
Loneliness
15D instrument of health-related quality of life - 15D (Sintonen)
Time frame: Post-intervention (10 weeks)
Health-related quality of life
24 secondary outcomes
De Jong Gierveld Loneliness Scale 11 item
Time frame: Baseline (before intervention), 6- and 12-months follow up
15D instrument of health-related quality of life - 15D (Sintonen)
Time frame: Baseline (before intervention), 6- and 12-months follow up.
Multidimensional scale of perceived social support (MSPSS)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Pain Brief Inventory
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Perceived Stress Scale (PSS-10)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
EURO-QOL 5D-5L
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Satisfaction with Life scale (SWLS)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Spanish Subjective Happiness Scale
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
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
Cantril Ladder
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
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
Lubben Social Network Scale-6
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Club/association participation
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
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
PHQ-9 Patient health questionnaire
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
General anxiety disorder (GADS - 7)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
SPANE: Scale of positive and negative experience
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The 6-item neighborhood attachment scale (NAS)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Neighborhood aesthetics
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Nature Connection Index (NCI)
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The International Physical Activity Questionnaires (IPAQ).
Time frame: Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Intrinsic motivation Inventory (IMI)
Time frame: During intervention (4 week) and Post-Intervention (10 weeks)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 39385940Sachs 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.
- Background: PubMed 39616375Vert 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.
- Background: PubMed 38218784Coll-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.
- BackgroundLitt, 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: PubMed 34179921Jansson 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.
- Derived from this study: PubMed 42923291Papon V, Jahn B, Sroczynski G, Litt JS, Coll-Planas L, Maso-Aguado M, Arvandi M, Navarro JS, Kuchin I, Puntscher S, Siebert U, Rochau U. Comparative effectiveness of nature-based social prescribing to alleviate loneliness in Spain: a decision analysis informed by the RECETAS trial. Front Psychol. 2026 Oct 8;17:1891830. doi: 10.3389/fpsyg.2026.1891830. eCollection 2026.
- Derived from this study: PubMed 42662493Coll-Planas L, Maso-Aguado M, Briones-Buixassa L, Morato A, Mendez S, Carbo A, Fuente-Vidal A, Olivella-Cirici M, Casajuana Kogel C, Bartova A, Cattaneo L, Jansson AH, Kolster A, Novotna B, Opacin N, Papon V, Puntscher S, Rautiainen LJ, Rochau U, Blancafort-Alias S, Daher C, Bekessy S, Acurio-Paez D, Garcia Velez GE, Holmerova I, Johnson K, Segura LG, Siebert U, Pitkala KH, Sanz S, Litt JS. Effectiveness of a nature-based social prescribing intervention on loneliness and health-related quality of life among vulnerable urban adults (RECETAS-BCN): an observer-blinded randomised controlled trial. Lancet Reg Health Eur. 2026 Aug 18;69:101821. doi: 10.1016/j.lanepe.2026.101821. eCollection 2026 Oct.
- Derived from this study: PubMed 42267287Papon V, Puntscher S, Maso-Aguado M, Arvandi M, Jahn B, Jones M, Beardmore A, Olivella-Cirici M, Briones-Buixassa L, Coll-Planas L, Litt JS, Siebert U, Rochau U. Evaluating the social return on investment of nature-based social prescribing to alleviate loneliness: a randomized controlled trial in Barcelona. Front Public Health. 2026 May 25;14:1774155. doi: 10.3389/fpubh.2026.1774155. eCollection 2026.
- Derived from this study: PubMed 42106778Papon V, Puntscher S, Arvandi M, Jahn B, Litt JS, Coll-Planas L, Maso-Aguado M, Pitkala KH, Laakkonen ML, Roitto HM, Holmerova I, Bartova A, Jones M, Drummond M, Siebert U, Rochau U. Protocol for the health economic evaluation of nature-based social prescribing against loneliness alongside the RECETAS trials. BMC Public Health. 2026 May 9;26(1):2001. doi: 10.1186/s12889-026-27698-2.
- website of the European Projecte RECETASLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jill S Litt, PhD principal investigator
Barcelona Institute for Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based social intervention (NBSI), referred as Friends in Nature (FiN) in people with Loneliness, run by University of Vic - Central University of Catalonia at 1 site in Spain.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
De Jong Gierveld Loneliness Scale 11 item (time frame: Post-intervention (10 weeks)). The study lists 2 primary outcomes in all. 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 NCT05488496, which also lists 9 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 11 Feb 2025.