LonelinessRECETASNCT05507684
Effects of Nature-based Group Intervention on Quality-of-life in Lonely Older People Living in Assisted Living Facities
A study testing Nature-based social prescribing group intervention in people with Loneliness, run by University of Helsinki at 1 site in Finland.
Trial summary
RECETAS (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project (H2020 No 945095) that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- Nature-based social prescribing group intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteFinland
- Study dates
- 21 Feb 2023to 28 Feb 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age at least 55 years
- Suffers from loneliness at least sometimes
- lives permanently in assisted living facility
- is voluntary to participate
- has Minimental Examination at least 15 points or CPS <5 (not being moderately-severly cognitively impaired)
- is able to move independently or dependently with or without assisting devices
- sufficient sight and hearing to participate in group activities
Who cannot join
- having a serious illness with a prognosis less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RECETAS (Re-Imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) in Helsinki
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project (H2020 No 945095) that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. Definitions: Loneliness is the perception of feeling alone, even if surrounded by people. Social prescription is a non-medical community referral approach to connect individuals with community resources to support wellbeing. Nature-based social intervention (NBSI) is a structured therapeutic groupbased social intervention that specifically include access to nature as a main component. Nature-based experiences may facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Read more
Hypothesis: NBSI in vulnerable people suffering from loneliness is more effective than usual social and health care on improving their health-related quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: This trial aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable people suffering from loneliness in the assisted living facilities in Helsinki. In Helsinki, the main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on changes of their health-related quality of life (HRQOL) and loneliness compared to usual social and health care at end of intervention, and at 6-,and 12- months post-randomization.
Methods: The study design is a randomized controlled trial (RCT). The RCT will include also a process evaluation, a qualitative study and a Health Economics evaluation. Therefore, 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.
The recruitment will be performed screening residents in Helsinki assisted living facilities by a survey. A total of 316 participants will be randomly allocated in two groups (c.158 each) after baseline assessments: intervention and control. Participants will sign the informed consent. The intervention is a group-based, multicomponent, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. It is based on the "Circle of Friends" methodology.
Read the detailed description
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. This project has received funding from tte 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 even in old age, being as dangerous as smoking or obesity: it reduces people's lifespan, and it is associated with increased use of health and social services and it impairs people's quality-of-life. 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 social intervention (NBSI) is a structured therapeutic group-based social intervention that specifically include access to nature as a main component. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Justification: NBSI in urban areas may 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 and technological infrastructure needed to support social and community cohesion.
Hypothesis: NBSI in vulnerable older people in assisted living facilities suffering from loneliness is more effective than usual social and health care on improving their quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: The study aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable older people in assisted living facilities suffering from loneliness in the area of Helsinki. The main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on the changes of loneliness and health-related quality of life compared to usual social and health care at 3-, 6-, and 12- months post-randomization.
Methods: The study design is a randomized controlled trial (RCT). The RCT will also include a process evaluation, a 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. The recruitment will be performed by screening residents in Helsinki assisted living facilities by a survey inclusing 1500 residents. Inclusion criteria will be age 65+ years, suffering from loneliness, living permanently in assisted living facility, being voluntary to participate, having Minimental Examination at least 15 point (not being moderately-severly cognitively impaired), being able to move independently with or without assisting devices, sufficient sight and hearing and not having a seirous illnes with a prognosis than 6 months. A total of 316 participants will be randomly allocated in two groups (c.158 each) after baseline assessments: intervention and control. Participants will sign the informed consent. The intervention is a group-based, multicomponent, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. It is based on the "Circle of Friends" methodology developed in Helsinki University. Participants in the intervention arm meet in closed groups including 5-12 participants once a week for 9 times. The group activities include nature-based activities and discussions on them and participants' loneliness. The groups facilitators will use group dynamics to facilitate participants' mutual interaction and to support their self-efficacy. Control group participants will receive usual care, and a list of nature-based resources available in their area.
Main outcome measures will be changes in loneliness by De Jong Gierveld Loneliness scale and health-related quality-of-life by 15D measure. Secondary measures will be changes in wellbeing (Psychological Wellbeing scale), EuroQual 5D-5L, cognition (Minimental State examination, Clock-drawing test, verbal fluency), walking speed and frailty (Physical frailty), self efficacy (Generalized Self-Efficacy scale), sleep quality, attachment ot neighbourhood (12 Neighborhood Assessment Scale), and relationship with nature (NR-6). THe use of health and social services will be collected from central records and health economic analyses performed.
- Conditions
- Loneliness
- Being tested
- Nature-based social prescribing group intervention
- Keywords
- Loneliness, nature activities, group intervention, socialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based social prescribing group interventionOther
Groups of 5-12 persons will formed from one assisted living facility. All of them will undergo an individual interview to assess their wishes for the nature-based activities.
Participants meet in a closed group for 9 times once a week for 10 weeks. All 2-4 hour sessions will include nature-based activities and mutual discussions about the experiences of nature and loneliness.
2 professionals will facilitate and observe the group more thoroughly, give feedback to each other, and make use of group dynamics. They write diaries on each session and receive feedback from their trainers. The groups are objective oriented (aiming to alleviate loneliness, to improve participants' self-efficacy), client oriented and aim with favorable group dynamics to mature, self-directing group in which the participants have made friends with each other and want meet with each other without the facilitators after the official group intervention is over.
| Study group | Role | What they receive |
|---|---|---|
| Nature-based social prescribing group intervention | Experimental | Groups of 5-12 persons will formed from one assisted living facility. All of them will undergo an individual interview to assess their wishes for the nature-based activities.
Participants meet in a closed group 9 times for once a week for 10 weeks. All 2-4 hour sessions will include nature-based activities and mutual discussions about the experiences of nature and loneliness.
2 professionals will facilitate and observe the group more thoroughly, give feedback to each other, and make use of group dynamics. They write diaries on each session and receive feedback from their trainers. The groups are objective oriented (aiming to alleviate loneliness, to improve participants' self-efficacy), client oriented and aim with favorable group dynamics to mature, self-directing group in which the participants have made friends with each other and want meet with each other without the facilitators after the official group intervention is over. Receives: Other: Nature-based social prescribing group intervention |
| Control | No intervention | The control arm will receive individually usual care in assisted living facility (e.g. the existing social prescription as available) Usual care is the appropriate comparison rather than a placebo for complex interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health related quality of life
15D health-related quality of life instrument. 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: From baseline to 3months, 6months, 12 months
Change in loneliness
Modified De Jong Gierveld Loneliness Scale as a continuous scale (minimum 11 (best) and maximum 55 (worst))
Measured: From baseline to 3months, 6months, 12 months
Secondary outcomes (17)
Change in Psychological Wellbeing
Psychological Wellbeing Scale by Routasalo et al. 2009 (Minimum 0 (worst) and maximum 1 (best).
Measured: From baseline to 3months, 6months, 12 months
Change in executive function
Clock Drawing test (Minimum 0 (worst) and maximum 6 (best).
Measured: From baseline to 3months, 6months, 12 months
Change in cognition
Verbal Fluency (Minimum 0 (worst) and maximum >30 (best)).
Measured: From baseline to 3months, 6months, 12 months
Minimental State Examination
Measured: Only baseline
Change in self Efficacy
Generalized Self-Efficacy scale by Schwarzer \& Jerusalem 1995
Measured: From baseline to 3months
Change in frailty phenotype
Physical frailty
Measured: Only baseline
Change in blood pressure
Blood pressure
Measured: From baseline to 3months and 12 months
Change in sleep quality
One item questions
Measured: From baseline to 3months, 6months, 12 months
Change in attachment to neighbourhood
Neighborhood Assessment Scale
Measured: From baseline to 3months
Change in relationship with nature
Questions related to nature attitudes
Measured: From baseline to 3months
Use of health and social services
Use of health and social services retrieved from registers
Measured: during 12 months from baseline
Health economic analyses (costs of health services with EQ5D-5L)
EuroQOL 5D-5L
Measured: During 12 months (3mo, 6mo, 12mo)
Change in social relationships
Number of new friends, continuation of group activity, satisfaction with relationships
Measured: From baseline to 3months, 6months, 12 months
Repeated wellbeing before, during and after the intervention
4 items related to psychological and physical wellbeing
Measured: Baseline, during the intervention and at 3 months
Repeated short measure of wellbeing
4 items related to psychological and physical wellbeing
Measured: Baseline, during the intervention and at 3 months
Satisfaction with social relationships
Items on social relationships and social activity
Measured: Baseline, 3 months
Number and time spent on outdoor activities
Number of outdoor activities and time spent there during the intervention
Measured: 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start21 Feb 2023
- Primary completion28 Jan 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Barcelona Institute of Global Health, Helsinki City Older People's Services, The Finnish Association for the Welfare of Older People
- Responsible party
- Principal investigator, Kaisu Pitkala, University of Helsinki
- Investigators
- Jill S Litt, PhD, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507684
- Sponsor's protocol ID
- 945095 HEL
- Acronym
- RECETAS
- Status last verified
- Feb 2025
- First submitted
- 12 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
- Yes
Publications
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 42106778Pitkala KH, Rautiainen L, Kautiainen H, Aalto UL, Kolster A, Laakkonen ML, Partonen T, Roitto HM, Puntscher S, Rochau U, Siebert U, Bartova A, Holmerova I, Coll-Planas L, Litt JS, Strandberg T, Jansson AH. Effectiveness of nature-based group intervention in loneliness and health-related quality-of-life in lonely older adults living in assisted living facilities-a randomised controlled trial. Age Ageing. 2026 Feb 1;55(2):afag009. doi: 10.1093/ageing/afag009.
PubMed 41638234Vert 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 39616375Pitkala KH, Rautiainen L, Aalto UL, Kautiainen H, Kolster A, Laakkonen ML, Partonen T, Roitto HM, Strandberg TE, Opacin N, Puntscher S, Siebert U, Coll-Planas L, Sachs AL, Litt JS, Jansson AH; RECETAS project. Participants' baseline characteristics and feedback of the nature-based social intervention "friends in nature" among lonely older adults in assisted living facilities in finland: a randomised controlled trial of the RECETAS EU-project. BMC Geriatr. 2024 Oct 7;24(1):812. doi: 10.1186/s12877-024-05408-0.
PubMed 39375627Coll-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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECETAS (Re-Imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) in Helsinki
- ClinicalTrials.gov ID
- NCT05507684
- Acronym / sponsor ID
- RECETAS / 945095 HEL
- Conditions
- Loneliness
- Keywords
- Loneliness, nature activities, group intervention, socialization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Barcelona Institute of Global Health, Helsinki City Older People's Services, The Finnish Association for the Welfare of Older People
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project (H2020 No 945095) that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. Definitions: Loneliness is the perception of feeling alone, even if surrounded by people. Social prescription is a non-medical community referral approach to connect individuals with community resources to support wellbeing. Nature-based social intervention (NBSI) is a structured therapeutic groupbased social intervention that specifically include access to nature as a main component. Nature-based experiences may facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Hypothesis: NBSI in vulnerable people suffering from loneliness is more effective than usual social and health care on improving their health-related quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: This trial aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable people suffering from loneliness in the assisted living facilities in Helsinki. In Helsinki, the main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on changes of their health-related quality of life (HRQOL) and loneliness compared to usual social and health care at end of intervention, and at 6-,and 12- months post-randomization.
Methods: The study design is a randomized controlled trial (RCT). The RCT will include also a process evaluation, a qualitative study and a Health Economics evaluation. Therefore, 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.
The recruitment will be performed screening residents in Helsinki assisted living facilities by a survey. A total of 316 participants will be randomly allocated in two groups (c.158 each) after baseline assessments: intervention and control. Participants will sign the informed consent. The intervention is a group-based, multicomponent, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. It is based on the "Circle of Friends" methodology.
Detailed description
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. This project has received funding from tte 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 even in old age, being as dangerous as smoking or obesity: it reduces people's lifespan, and it is associated with increased use of health and social services and it impairs people's quality-of-life. 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 social intervention (NBSI) is a structured therapeutic group-based social intervention that specifically include access to nature as a main component. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Justification: NBSI in urban areas may 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 and technological infrastructure needed to support social and community cohesion.
Hypothesis: NBSI in vulnerable older people in assisted living facilities suffering from loneliness is more effective than usual social and health care on improving their quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: The study aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable older people in assisted living facilities suffering from loneliness in the area of Helsinki. The main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on the changes of loneliness and health-related quality of life compared to usual social and health care at 3-, 6-, and 12- months post-randomization.
Methods: The study design is a randomized controlled trial (RCT). The RCT will also include a process evaluation, a 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. The recruitment will be performed by screening residents in Helsinki assisted living facilities by a survey inclusing 1500 residents. Inclusion criteria will be age 65+ years, suffering from loneliness, living permanently in assisted living facility, being voluntary to participate, having Minimental Examination at least 15 point (not being moderately-severly cognitively impaired), being able to move independently with or without assisting devices, sufficient sight and hearing and not having a seirous illnes with a prognosis than 6 months. A total of 316 participants will be randomly allocated in two groups (c.158 each) after baseline assessments: intervention and control. Participants will sign the informed consent. The intervention is a group-based, multicomponent, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. It is based on the "Circle of Friends" methodology developed in Helsinki University. Participants in the intervention arm meet in closed groups including 5-12 participants once a week for 9 times. The group activities include nature-based activities and discussions on them and participants' loneliness. The groups facilitators will use group dynamics to facilitate participants' mutual interaction and to support their self-efficacy. Control group participants will receive usual care, and a list of nature-based resources available in their area.
Main outcome measures will be changes in loneliness by De Jong Gierveld Loneliness scale and health-related quality-of-life by 15D measure. Secondary measures will be changes in wellbeing (Psychological Wellbeing scale), EuroQual 5D-5L, cognition (Minimental State examination, Clock-drawing test, verbal fluency), walking speed and frailty (Physical frailty), self efficacy (Generalized Self-Efficacy scale), sleep quality, attachment ot neighbourhood (12 Neighborhood Assessment Scale), and relationship with nature (NR-6). THe use of health and social services will be collected from central records and health economic analyses performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature-based social prescribing group intervention | Experimental | Other: Nature-based social prescribing group interventionGroups of 5-12 persons will formed from one assisted living facility. All of them will undergo an individual interview to assess their wishes for the nature-based activities. Participants meet in a closed group 9 times for once a week for 10 weeks. All 2-4 hour sessions will include nature-based activities and mutual discussions about the experiences of nature and loneliness. 2 professionals will facilitate and observe the group more thoroughly, give feedback to each other, and make use of group dynamics. They write diaries on each session and receive feedback from their trainers. The groups are objective oriented (aiming to alleviate loneliness, to improve participants' self-efficacy), client oriented and aim with favorable group dynamics to mature, self-directing group in which the participants have made friends with each other and want meet with each other without the facilitators after the official group intervention is over. |
| Control | No intervention | –The control arm will receive individually usual care in assisted living facility (e.g. the existing social prescription as available) Usual care is the appropriate comparison rather than a placebo for complex interventions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age at least 55 years
- Suffers from loneliness at least sometimes
- lives permanently in assisted living facility
- is voluntary to participate
- has Minimental Examination at least 15 points or CPS <5 (not being moderately-severly cognitively impaired)
Key exclusion criteria (1 listed)
- having a serious illness with a prognosis less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature-based social prescribing group interventionGroups of 5-12 persons will formed from one assisted living facility. All of them will undergo an individual interview to assess their wishes for the nature-based activities. Participants meet in a closed group for 9 times once a week for 10 weeks. All 2-4 hour sessions will include nature-based activities and mutual discussions about the experiences of nature and loneliness. 2 professionals will facilitate and observe the group more thoroughly, give feedback to each other, and make use of group dynamics. They write diaries on each session and receive feedback from their trainers. The groups are objective oriented (aiming to alleviate loneliness, to improve participants' self-efficacy), client oriented and aim with favorable group dynamics to mature, self-directing group in which the participants have made friends with each other and want meet with each other without the facilitators after the official group intervention is over. | Other | Nature-based social prescribing group intervention |
Primary outcome
Change in health related quality of life
Time frame: From baseline to 3months, 6months, 12 months
15D health-related quality of life instrument. 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.
Change in loneliness
Time frame: From baseline to 3months, 6months, 12 months
Modified De Jong Gierveld Loneliness Scale as a continuous scale (minimum 11 (best) and maximum 55 (worst))
17 secondary outcomes
Change in Psychological Wellbeing
Time frame: From baseline to 3months, 6months, 12 months
Change in executive function
Time frame: From baseline to 3months, 6months, 12 months
Change in cognition
Time frame: From baseline to 3months, 6months, 12 months
Minimental State Examination
Time frame: Only baseline
Change in self Efficacy
Time frame: From baseline to 3months
Change in frailty phenotype
Time frame: Only baseline
Change in blood pressure
Time frame: From baseline to 3months and 12 months
Change in sleep quality
Time frame: From baseline to 3months, 6months, 12 months
Change in attachment to neighbourhood
Time frame: From baseline to 3months
Change in relationship with nature
Time frame: From baseline to 3months
Use of health and social services
Time frame: during 12 months from baseline
Health economic analyses (costs of health services with EQ5D-5L)
Time frame: During 12 months (3mo, 6mo, 12mo)
Change in social relationships
Time frame: From baseline to 3months, 6months, 12 months
Repeated wellbeing before, during and after the intervention
Time frame: Baseline, during the intervention and at 3 months
Repeated short measure of wellbeing
Time frame: Baseline, during the intervention and at 3 months
Satisfaction with social relationships
Time frame: Baseline, 3 months
Number and time spent on outdoor activities
Time frame: 3 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 42106778Papon 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.
- Derived from this study: PubMed 41638234Pitkala KH, Rautiainen L, Kautiainen H, Aalto UL, Kolster A, Laakkonen ML, Partonen T, Roitto HM, Puntscher S, Rochau U, Siebert U, Bartova A, Holmerova I, Coll-Planas L, Litt JS, Strandberg T, Jansson AH. Effectiveness of nature-based group intervention in loneliness and health-related quality-of-life in lonely older adults living in assisted living facilities-a randomised controlled trial. Age Ageing. 2026 Feb 1;55(2):afag009. doi: 10.1093/ageing/afag009.
- Derived from this study: PubMed 39616375Vert 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.
- Derived from this study: PubMed 39375627Pitkala KH, Rautiainen L, Aalto UL, Kautiainen H, Kolster A, Laakkonen ML, Partonen T, Roitto HM, Strandberg TE, Opacin N, Puntscher S, Siebert U, Coll-Planas L, Sachs AL, Litt JS, Jansson AH; RECETAS project. Participants' baseline characteristics and feedback of the nature-based social intervention "friends in nature" among lonely older adults in assisted living facilities in finland: a randomised controlled trial of the RECETAS EU-project. BMC Geriatr. 2024 Oct 7;24(1):812. doi: 10.1186/s12877-024-05408-0.
- Derived from this study: PubMed 38218784Coll-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill S Litt, PhD principal investigator
Barcelona Institute for Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based social prescribing group intervention in people with Loneliness, run by University of Helsinki at 1 site in Finland.
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 7 inclusion and 1 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 Finland. 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?
Change in health related quality of life (time frame: From baseline to 3months, 6months, 12 months). 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 NCT05507684, which also lists 5 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.