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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Nature-based social intervention (NBSI); Behavioral: Usual care + menu with nature-based activities

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 Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Coll Planas, PhD; Phone Number: 0034938816025; Email: laura.coll@uvic.cat
• Study Contact Backup: Name: Sergi Blancafort, PhD; Email: sergi.blancafort@uab.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Sergi Blancafort
    • Contact: Sergi Blancafort; Email: sergi.blancafort@uab.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Aged 18 or over;
3. 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;
4. Willing to undergo study measurements.

Exclusion Criteria:

1. Unable to go outdoors independently due to poor mobility or severe diseases;
2. Poor hearing or sight in case it prevents them to participate of the group dynamics and activities in the nature;
3. Mild, moderate or severe cognitive decline (test de Pfeiffer >2 fails);
4. Any mental health disorder that might interfere with the group dynamics;
5. Severe disease with poor prognosis < 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; The intervention arm will undergo the following steps: Groups of 5-15 persons living in the same area. Two trained facilitators support the group dynamics fostering empowerment.; Each participant undergoes a one-to one personalized interview with the facilitator(s) to build the relationship and know participants' expectations and characteristics.; 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); 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.
Active Comparator: Control arm; 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; Social prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
De Jong Gierveld Loneliness Scale 11 item	Loneliness	Baseline (before intervention), 6- and 12-months follow up
15D instrument of health-related quality of life - 15D (Sintonen)	Health-related quality of life	Baseline (before intervention), 6- and 12-months follow up.
Multidimensional scale of perceived social support (MSPSS)	Perceived Social Support	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Pain Brief Inventory	Pain	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Perceived Stress Scale (PSS-10)	Stress	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	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	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	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	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	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Cantril Ladder	Wellbeing assessment	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	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Lubben Social Network Scale-6	Social interaction	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Club/association participation	Social interaction	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	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
PHQ-9 Patient health questionnaire	Affect/Depression	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
General anxiety disorder (GADS - 7)	Anxiety	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
SPANE: Scale of positive and negative experience	Emotions	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The 6-item neighborhood attachment scale (NAS)	Neighborhood	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Neighborhood aesthetics	Neighborhood	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
Nature Connection Index (NCI)	Nature dose	Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up
The International Physical Activity Questionnaires (IPAQ).	Physical activity	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	During intervention (4 week) and Post-Intervention (10 weeks)
Relatedness to Others in Physical Activity Scale (ROPAS)	Social support	During the intervention (4 week), Post-intervention (10 weeks), 6- and 12-months follow up.

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: Barcelona Institute for Global Health; Public Health Agency of Barcelona; Fundacio Salut i Envelliment UAB
• Investigators: Principal Investigator: Jill S Litt, PhD, Barcelona Institute for Global Health

Publications and helpful links

General Publications

• 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.

Helpful Links

• website of the European Projecte RECETAS

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: mental health; prevention; community-based; complex intervention; wellbeing; urban health; social prescription; nature-based therapy
• Other Study ID Numbers: 945095 BCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No