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

Loneliness Clinical Trial

— RECETAS-BCN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488496
• Other study ID #: 945095 BCN
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2023
• Source: University of Vic - Central University of Catalonia
• Contact: Laura Coll Planas, PhD
• Phone: 0034938816025
• Email: laura.coll[@]uvic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Loneliness

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Sergi Blancafort	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia	Barcelona Institute for Global Health, Fundacio Salut i Envelliment UAB, Public Health Agency of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   website of the European Projecte RECETAS