Clinical trial NCT05522140: Testing a Nature-based Socila Intevention on Loneliness: the RECETAS-PRG Trial
Official title: Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Prague - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: social prescribing
social intervention
nature-based activities
mental health
wellbeing
prevention
nature-based therapy
complex intervention
community-based
urban health
loneliness
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Barcelona Institute for Global Health
First posted: 2022-08-30
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RECETAS (Re-imagine 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 pople to nature-based social actvitities through a group-based intervention.

Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. RECETAS aims to design and test nature-based socila itervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different citites: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If succesful, this will provide an evidence-based approach for using social prescribing to address loneliness.

Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.

A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.

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.

Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI tratment and control arms. All of them will be asked to sign the informed consent form.

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

Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. Loneliness is a modifiable health condition that is potentially dangerous to health and can reduce people's life span. In Europe, 30 million people European adults frequently felt lonely.

Social prescription is a non-medical approach that aims to connect people with the community through social outdoor activities to improve their wellbeing. NBSP is an intervention where nature-based social activities connect people, places and institutions that form strong social networks and connections. Nature-based activities can facilitate a dynamic process and social interactions and can thus contribute to reducing feelings of loneliness. We will design and test 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 urban areas: Barcelona, Helsinki, Prague, Cuenca in Ecuador and Melbourne.

Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.

A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.

Methods: A randomized controlled trial (RCT) will be used to assess the effect of NBSI on reducing feelings of loneliness. The RCT will use mixed-method approach collecting qunatitative information to assess the the main outcomes and qualitative methods to explore participant's and professional's experiences. ISGlobal coordinates the overall RECETAS project. Charles University leads the implementation of the RECETAS-PRG and is responsible for the recruitment process, intervention, assessment, evaluation, data analysis and qualitative part of the study.

Recruitment will be carried out in cooperation with the Centre of Longevity and Long-Term Care, the Czech Alzheimer's Society, general practitioners and other outpatient specialists, and home care organizations based on a long-term focus on the target group. Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arm (158 each): NBSP intervention arm and control arm. All of them will be asked to sign the informed consent form.

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

Eligibility criteria: Inclusion Criteria:

1. Able to give informed consent in Czech
2. Older adults (60+) with a risk of social isolation and loneliness
3. Currently experiencing loneliness according to the screening question "Do you suffer from loneliness?"
4. Willing to undergo study measurement.

Exclusion Criteria:

1. Unable to go outdoors 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. Severe, moderate or mild cognitive decline.
4. Any mental health disorders that might interfere with the group dynamics.
5. Severe disease with poor prognosis \< 6 months.

Primary outcomes:
measure: De Jong Gierveld Loneliness Scale 11 item
timeFrame: Post-intervention (10 weeks)
measure: 15D instrument of health-related quality of life
timeFrame: Post-intervention (10 weeks)
Secondary outcomes:
measure: Psychological Wellbeing Scale by Routasalo et al. 2009
timeFrame: From baseline to 3months, 6months, 12 months
measure: Clock drawing test
timeFrame: From baseline to 3months, 6months, 12 months
measure: Instrumental Activities of Daily Living Scale
timeFrame: From baseline to 3months, 6months, 12 months
measure: 15D instrument of health-related quality of life
timeFrame: Baseline (before intervention), 6- and 12-months follow up
measure: De Jong Gierveld Loneliness Scale 11 item
timeFrame: Baseline (before intervention), 6- and 12-months follow up
measure: International Physical Activity Questionnaire
timeFrame: From baseline to 3months, 6months, 12 months
measure: Geriatric Depression Scale
timeFrame: From baseline to 3months, 6months, 12 months
measure: Lubben Social Network Scale
timeFrame: From baseline to 3months, 6months, 12 months
measure: EURO-QOL 5D-5L
timeFrame: From baseline to 3months, 6months, 12 months
measure: ICEpop CAPability mesure for Adults (ICECAP-A)
timeFrame: From baseline to 3months, 6months, 12 months
measure: Nature connection index
timeFrame: From baseline to 3months, 6months, 12 months
Other outcomes:
Locations:
city: Prag
country: Czechia
facility: Charles University
Study officials:
affiliation: Barcelona Institute for Global Health
name: Jill S Litt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Litt, 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
citation: Coll-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.
citation: Vert 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.
citation: 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.
citation: Girdler NM. Air-gun injury to the face. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):137. doi: 10.1016/0030-4220(94)90133-3. No abstract available.