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LonelinessRECETASNCT05522140

Testing a Nature-based Socila Intevention on Loneliness: the RECETAS-PRG Trial

A study testing Nature-based social intervention (NBIS) in people with Loneliness, run by Vladimíra Dostálová at 1 site in Czechia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. 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 (NBIS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteCzechia
Study dates
27 Mar 2023to 31 Oct 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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • Charles University

    Prague

Other trials in Czechia

About this study

Official title: Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Prague - a Randomized Controlled Trial

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.

Read more

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.

Read the 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.

Conditions
Loneliness
Being tested
Nature-based social intervention (NBIS), Usual care + menu with nature based activities
Keywords
social prescribing, social intervention, nature-based activities, mental health, wellbeing, prevention, nature-based therapy, complex intervention, community-based, 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 (NBIS)Behavioural

    Nature-based social prescribing is a multicomponent, multi-level, behaviorally based complex intervention applaied by 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" methodolgy focused on loneliness(Jansson A, Pitkälä KH, 2021) adapted to the cultural context of Prague and the target population (partitipants) of adults who lives in Prague. Participants start with an individual session and then meet once a week for two hours for 10 weeks.

    At the first meeting together, participants select the nature-based activities they wish to conduct through a co-created menu.

  • 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 groups in NCT05522140
Study groupRoleWhat they receive
Intervention armExperimentalThe intervention arm will undergo following steps: 1. Groups of 5-15 persons, who lives in Prague. Two trained facilitators support the group dynamics forstering empowerment. 2. Each participant will undergo an individual session with the facilitator(s) aimed at building relationships and trust, and getting to know the expectations and characteristics of the participants. 3. 9 group activities with the aim to promote accessibility and engagement with the nature and outdoor activities available in their town. Collaborative mapping of nature-based community activities will direct the group to activities they want to approach and test.
Receives: Behavioral: Nature-based social intervention (NBIS)
Control armActive comparatorParticipants randomly assigned to the control arm will receive usual care, which is a list of community resources in the city (Prague). Usual care is an appropriate comparison rather than 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.

  1. De Jong Gierveld Loneliness Scale 11 item

    Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))

    Measured: Post-intervention (10 weeks)

  2. 15D instrument of health-related quality of life

    Change in health related quality of life. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.

    Measured: Post-intervention (10 weeks)

Secondary outcomes (11)
  1. Psychological Wellbeing Scale by Routasalo et al. 2009

    Change in psychological wellbeing.Minimum 0 (worst) and maximum 1 (best).

    Measured: From baseline to 3months, 6months, 12 months

  2. Clock drawing test

    Change in executive function. Minimum 0 (worst) and maximum 6 (best)

    Measured: From baseline to 3months, 6months, 12 months

  3. Instrumental Activities of Daily Living Scale

    Change in instrumental activities of daily living. Minimum 0 (worst) and maximum 10 (best)

    Measured: From baseline to 3months, 6months, 12 months

  4. 15D instrument of health-related quality of life

    Change in health related quality of life. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.

    Measured: Baseline (before intervention), 6- and 12-months follow up

  5. De Jong Gierveld Loneliness Scale 11 item

    Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))

    Measured: Baseline (before intervention), 6- and 12-months follow up

  6. International Physical Activity Questionnaire

    Change in physical activity. Minimum 1 (worst) and maximum 3 (best)

    Measured: From baseline to 3months, 6months, 12 months

  7. Geriatric Depression Scale

    Change in depression. Minimum 0 (best) and maximum 15 (worst)

    Measured: From baseline to 3months, 6months, 12 months

  8. Lubben Social Network Scale

    Change in social network. Minimum 0 (worst) and maximum 5 (best)

    Measured: From baseline to 3months, 6months, 12 months

  9. EURO-QOL 5D-5L

    Health economic analyses. Cost of health services with EQ5D-5L

    Measured: From baseline to 3months, 6months, 12 months

  10. ICEpop CAPability mesure for Adults (ICECAP-A)

    Self-reported measure of capability wellbeing for adults

    Measured: From baseline to 3months, 6months, 12 months

  11. Nature connection index

    Relationship with nature. Min = 1 Max = 7. Higher scores indicating stronger connectedness to nature

    Measured: From baseline to 3months, 6months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start27 Mar 2023
  3. Primary completion26 Feb 2025
  4. Study completion31 Oct 2025 (estimated)

Resources

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
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522140
Sponsor's protocol ID
945095 PRG
Acronym
RECETAS
Status last verified
Feb 2025
First submitted
25 Aug 2022
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 38218784
  • 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.

    PubMed 39616375
  • 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 39385940
  • 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 34179921
  • Papon 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

Questions about this trial

What is this clinical trial studying?

A study testing Nature-based social intervention (NBIS) in people with Loneliness, run by Vladimíra Dostálová at 1 site in Czechia.

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 28 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 Czechia. 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 NCT05522140, which also lists 6 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 28 Feb 2025.

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