Overview

This trial is active, not recruiting.

Condition mood (psychological function)
Treatment horticultural therapy
Sponsor National University, Singapore
Collaborator National Parks Board, Singapore
Start date April 2015
End date October 2015
Trial size 69 participants
Trial identifier NCT02495194, B-15-016

Summary

The objective of this study is to determine whether horticultural therapy would improve the psychological well-being of the older adults. 70 healthy elderly were randomized into the active horticultural therapy or the waitlist control group. Sessions will be conducted weekly for 12 weeks, and monthly for 3 months. Participants would be assessed at 3 time-points: at the start, at 3-months and at 6-months.

It was hypothesized that as compared to the waitlist control group, participants in the active horticultural therapy will have (1) lower depression and anxiety symptomatology; (2) higher life satisfaction; (3) feel more socially connected; and (4) improved cognitive functioning.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
15 sessions of Horticultural Therapy program teaching the elderly about gardening techniques and for them to benefit from the therapeutic effects of the parks
horticultural therapy
The Horticultural Therapy intervention consists of 1 hour sessions weekly for first 3 months, followed by monthly session for the next 3 months. They will be taught on the basic gardening techniques such as sowing, weeding and fertilization during the hands-on sessions. They will also be taken on walks to the various parks to enjoy the therapeutic effect of the park greenery
(Other)
Participants will receive the same horticultural therapy program at the end of the assessments
horticultural therapy
The Horticultural Therapy intervention consists of 1 hour sessions weekly for first 3 months, followed by monthly session for the next 3 months. They will be taught on the basic gardening techniques such as sowing, weeding and fertilization during the hands-on sessions. They will also be taken on walks to the various parks to enjoy the therapeutic effect of the park greenery

Primary Outcomes

Measure
Change from baseline Zung Self-Rating Depression Scale (SDS) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Zung Self-Rating Anxiety Scale (SAS) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Ryff's Scales of Psychological Well-being at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Satisfaction with Life Scale (SWLS) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Friendship Scale (FS) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Interleukin 6 (IL-6) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Interleukin-1 beta (IL-1β) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline C-reactive protein (CRP) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Cortisol at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Brain-derived neurotrophic factor (BDNF) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Dehydroepiandrosterone sulphate (DHEAS) at 3-months and 6-months
time frame: baseline, 3-months, 6-months

Secondary Outcomes

Measure
Change from baseline Montreal Cognitive Assessment (MoCA) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Clinical Dementia Rating (CDR) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Digit Span Task at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Colour Trails Tests (CTT) at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Block Design at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from baseline Semantic Verbal Fluency at 3-months and 6-months
time frame: baseline, 3-months, 6-months
Change from Basic Health Screen (composite) at 3-months and 6-months
time frame: baseline, 3-months, 6-months

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

Inclusion criteria: 1. Community-living elderly aged between 60 to 85 years AND 2. able to provide informed consent AND 3. function independently AND 4. With a minimum score of 22 and above on the Montreal Cognitive Assessment. Exclusion criteria: 1. Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis), 2. Does not have a minimum score of 22 and above on the Montreal Cognitive Assessment OR 3. Currently suffering from or have history of severe medical conditions e.g. cancer, stroke, Parkinson disease OR 4. History of severe psychiatric conditions e.g. schizophrenia, bipolar disorder OR 5. Dementia OR 6. Undergoing another therapy at the same time OR 7. Significant visual or hearing impairment OR 8. Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.

Additional Information

Official title Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial
Principal investigator Roger CM Ho, FRCP
Description Participants Study participants are community-dwelling elderly. Assessments Demographic data will be collected at the start. Psychological tests for depression, anxiety and psychological well-being as well as neuropsychological tests of cognitive functioning will be done at the start, at 3-months and at 6-months. Blood samples will also be collected at all three time points. Intervention Sessions This is an intervention study with a waitlist control group design. The strength of this design is its experimental nature with randomization. The Horticultural Therapy intervention is delivered by a trained practitioner at various locations and consists of 1 hour sessions weekly for first 3 months, followed by monthly session for the next 3 months. The extension of monthly sessions for 3 months is to determine sustainability and longer-term changes. The intervention is designed to cultivate an interest in gardening and promote relaxation. This will be achieved in stages, facilitated by trained volunteers and practitioners. The plant would be selected based on subjects' profiles e.g. familiarity, preference, safety and its maintenance would be followed up every fortnight. Park venues were selected based on patients profiles and park features e.g. familiarity, comfort under weather, safety. The control group will be placed on a waiting list and only be contacted for assessments. They will receive intervention after the active treatment group at a later date. The horticultural therapy is conducted solely for the purpose of this research.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by National University, Singapore.