Effects of Nature-based Group Intervention on Quality-of-life in Lonely Older People Living in Assisted Living Facities

NCT05507684 | Active Not Recruiting DMC

• 1 other identifier: 945095 HEL
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Loneliness

Keywords

Loneliness, nature activities, group intervention, socialization

Outcome Measures

Primary Outcomes (2)

• 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.

  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))

  From baseline to 3months, 6months, 12 months

Secondary Outcomes (17)

• Change in Psychological Wellbeing

  From baseline to 3months, 6months, 12 months

• Change in executive function

  From baseline to 3months, 6months, 12 months

• Change in cognition

  From baseline to 3months, 6months, 12 months

• Minimental State Examination

  Only baseline

• Change in self Efficacy

  From baseline to 3months

Other Outcomes (1)

• Group participants' opinions

  during the group and at 3 months

Study Arms (2)

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.

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.

Interventions

Nature-based social prescribing group intervention OTHER

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.

Nature-based social prescribing group intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• having a serious illness with a prognosis less than 6 months.

Sponsors & Collaborators

• University of Helsinki: lead
• Barcelona Institute of Global Health: collaborator
• Helsinki City Older People's Services: collaborator
• The Finnish Association for the Welfare of Older People: collaborator

Study Sites (1)

Helsinki City assisted living facilities

Helsinki, Finland

Location

Related Publications (4)

• Pitkala 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.

  PMID: 41638234 DERIVED

• 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.

  PMID: 39616375 DERIVED

• Pitkala 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.

  PMID: 39375627 DERIVED

• 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.

  PMID: 38218784 DERIVED

Study Officials

• Jill S Litt, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor emerita

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: February 21, 2023
• Primary Completion: January 28, 2025
• Study Completion: February 28, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2022 - 2026
• Access Criteria: Study protocol has been submitted to a peer reviewed journal. Clinical study report will be available in 2026.

Locations

FI (1)