Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Barcelona - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 317
- Locations
- 1
- Primary Endpoint
- De Jong Gierveld Loneliness Scale 11 item
Study Overview
Brief Summary
RECETAS (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an European project (H2020 No 945095) that aims to reduce loneliness by linking lonely people to nature-based social activities through a group-based intervention.
Background: Loneliness is the perception of feeling alone, even if surrounded by people. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness. RECETAS aims design and test a nature-based social intervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different cities: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If successful, this will provide an evidence-based approach for using social prescribing to address loneliness.
Hypothesis: NBSI in vulnerable people suffering from loneliness is more effective than usual social and health care on reducing loneliness at post-intervention (10 weeks), 6- and 12-months follow up.
Objectives: to assess the effectiveness of a 10-week NBSI on loneliness in vulnerable people in the area of Barcelona suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization. We will also explore the processes and perceived impacts of the intervention.
A pilot study will be conducted (September-December 2022) before the RCT intervention (January 2023) with the aim to explore the feasibility and acceptability of the study procedures, including the primary and secondary outcome measures.
Methods: The study design is a randomized controlled trial (RCT) including a process evaluation based on Medical Health Council guidance, a nested qualitative study and a Health Economics evaluation.
The recruitment will be coordinated and operationalized with Community Development Plans (CDP). Individuals will be recruited from primary care settings, third-sector organizations, community groups, and volunteer organisations who screen for loneliness. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI treatment and control arms. All of them will be asked to sign the informed consent form.
The intervention model is adapted from the "Circle of Friends" methodology developed by the University of Helsinki (Jansson A, Pitkälä KH, 2021).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Pain Brief Inventory(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- EURO-QOL 5D-5L(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- The International Physical Activity Questionnaires (IPAQ).(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Spanish Subjective Happiness Scale(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- De Jong Gierveld Loneliness Scale 11 item(Baseline (before intervention), 6- and 12-months follow up)
- Multidimensional scale of perceived social support (MSPSS)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Satisfaction with Life scale (SWLS)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Club/association participation(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- PHQ-9 Patient health questionnaire(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- 15D instrument of health-related quality of life - 15D (Sintonen)(Baseline (before intervention), 6- and 12-months follow up.)
- Perceived Stress Scale (PSS-10)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- ICEpop CAPability measure for Adults (ICECAP-A)(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(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Cantril Ladder(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)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Nature Connection Index (NCI)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Relatedness to Others in Physical Activity Scale (ROPAS)(During the intervention (4 week), 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(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Lubben Social Network Scale-6(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Intrinsic motivation Inventory (IMI)(During intervention (4 week) and Post-Intervention (10 weeks))
- General anxiety disorder (GADS - 7)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- SPANE: Scale of positive and negative experience(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- The 6-item neighborhood attachment scale (NAS)(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)
- Neighborhood aesthetics(Baseline (before intervention), Post-intervention (10 weeks), 6- and 12-months follow up)