Clinical trial NCT02495194: Effects of Horticultural Therapy on Asian Elderly' Mental Health
Official title: Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood (Psychological Function)
Keywords: Promotion of psychological well-being
Horticultural therapy
Randomized Controlled Trial
Gardening
Elderly
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Parks Board, Singapore
First posted: 2015-07-13
Enrollment: 69
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Zung Self-Rating Depression Scale (SDS) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Zung Self-Rating Anxiety Scale (SAS) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Ryff's Scales of Psychological Well-being at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Satisfaction with Life Scale (SWLS) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Friendship Scale (FS) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Interleukin 6 (IL-6) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Interleukin-1 beta (IL-1β) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline C-reactive protein (CRP) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Cortisol at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Brain-derived neurotrophic factor (BDNF) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Dehydroepiandrosterone sulphate (DHEAS) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
Secondary outcomes:
measure: Change from baseline Montreal Cognitive Assessment (MoCA) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Clinical Dementia Rating (CDR) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Digit Span Task at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Colour Trails Tests (CTT) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Block Design at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from baseline Semantic Verbal Fluency at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
measure: Change from Basic Health Screen (composite) at 3-months and 6-months
timeFrame: baseline, 3-months, 6-months
Other outcomes:
measure: Demographic questionnaire
timeFrame: Baseline
measure: Feedback questionnaire
timeFrame: Baseline
Locations:
city: Singapore
country: Singapore
facility: Training and Research Academy; Jurong Point Shopping Centre
Study officials:
affiliation: National University of Hospital
name: Roger CM Ho, FRCP
role: PRINCIPAL_INVESTIGATOR
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