NCT02495194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

June 24, 2015

Last Update Submit

May 6, 2016

Conditions

Keywords

Promotion of psychological well-beingHorticultural therapyRandomized Controlled TrialGardeningElderly

Outcome Measures

Primary Outcomes (11)

  • Change from baseline Zung Self-Rating Depression Scale (SDS) at 3-months and 6-months

    The SDS (Zung, 1965) is a 20-item quantitative measurement of symptoms of depression. Participants rate each item regarding how they felt during the week preceding using a 4-point scale that ranges from 1 (a little of the time) to 4 (most of the time). A total raw score computed by summing the scores on the individual items will be converted into a percentage (the SDS index); the higher the SDS index, the greater the severity of depressive symptoms. Several studies have established the SDS as a reliable and valid instrument for measuring depressive symptoms (Biggs et al., 1978; Gabrys and Peters, 1985; Agrell and Dehlin, 1989).

    baseline, 3-months, 6-months

  • Change from baseline Zung Self-Rating Anxiety Scale (SAS) at 3-months and 6-months

    The SAS (Zung, 1971) will be used to measure anxiety of the participants in the preceding week. It is a 20-item self-report assessment designed to measure anxiety levels, based on cognitive, autonomic, motor and central nervous system symptoms. Each question is scored on a Likert-type scale of 1-4 (a little of the time) to (most of the time). Some questions are negatively worded to avoid the problem of set response. Overall assessment is done by total score. The total raw scores range from 20-80. The raw score then needs to be converted to an "Anxiety Index" score; the higher the SAS index, the greater the severity of depressive symptoms.

    baseline, 3-months, 6-months

  • Change from baseline Ryff's Scales of Psychological Well-being at 3-months and 6-months

    The Ryff Scales of Psychological Well-Being (Ryff and Singer, 1998) is an 18-item questionnaire which reflects the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.

    baseline, 3-months, 6-months

  • Change from baseline Satisfaction with Life Scale (SWLS) at 3-months and 6-months

    Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen and Griffin, 1985) will be administered. SWLS is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (not a measure of either positive or negative affect). It is a psychometrically sound measure (Larson, Diener and Emmons, 1985) and has been validated in a geriatric population (Diener et al., 1985). Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 1 (strongly disagree) to 7 (strongly agree). Total scores were computed by summing the scores on the individual items and ranged from 5 to 35, with higher scores indicating higher level of satisfaction with life.

    baseline, 3-months, 6-months

  • Change from baseline Friendship Scale (FS) at 3-months and 6-months

    Social connectedness scale will be measured using the Friendship Scale (Hawthorne, 2006). It is a 6-item questionnaire that measures both social isolation and social connectedness. Participants were asked to rate the frequency in which each statement describes them during the past four weeks on a 5-point Likert scale ranging from 0 (almost always) to 5 (not at all). Total scores were computed by summing the scores on the individual items and ranged from 0 to 24, with higher scores indicating higher level of social connectedness. The Friendship Scale was developed as a short, user-friendly, stand alone scale measuring perceived social isolation. It was validated with older adults with excellent internal structures, reliability and validity (Hawthorne, 2006; Hawthorne, 2008).

    baseline, 3-months, 6-months

  • Change from baseline Interleukin 6 (IL-6) at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

  • Change from baseline Interleukin-1 beta (IL-1β) at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

  • Change from baseline C-reactive protein (CRP) at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

  • Change from baseline Cortisol at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

  • Change from baseline Brain-derived neurotrophic factor (BDNF) at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

  • Change from baseline Dehydroepiandrosterone sulphate (DHEAS) at 3-months and 6-months

    10ml of fasting blood will be collected using CPT tube

    baseline, 3-months, 6-months

Secondary Outcomes (8)

  • Change from baseline Montreal Cognitive Assessment (MoCA) at 3-months and 6-months

    baseline, 3-months, 6-months

  • Change from baseline Clinical Dementia Rating (CDR) at 3-months and 6-months

    baseline, 3-months, 6-months

  • Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3-months and 6-months

    baseline, 3-months, 6-months

  • Change from baseline Digit Span Task at 3-months and 6-months

    baseline, 3-months, 6-months

  • Change from baseline Colour Trails Tests (CTT) at 3-months and 6-months

    baseline, 3-months, 6-months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Demographic questionnaire

    Baseline

  • Feedback questionnaire

    Baseline

Study Arms (2)

Active Horticultural Therapy

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

Behavioral: Horticultural Therapy

Waitlist Control Group

OTHER

Participants will receive the same horticultural therapy program at the end of the assessments

Behavioral: Horticultural Therapy

Interventions

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

Active Horticultural TherapyWaitlist Control Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-living elderly aged between 60 to 85 years AND
  • able to provide informed consent AND
  • function independently AND
  • With a minimum score of 22 and above on the Montreal Cognitive Assessment.

You may not qualify if:

  • Does not have a minimum score of 22 and above on the Montreal Cognitive Assessment OR
  • Currently suffering from or have history of severe medical conditions e.g. cancer, stroke, Parkinson disease OR
  • History of severe psychiatric conditions e.g. schizophrenia, bipolar disorder OR
  • Dementia OR
  • Undergoing another therapy at the same time OR
  • Significant visual or hearing impairment OR
  • Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Training and Research Academy; Jurong Point Shopping Centre

Singapore, Singapore, 460077, Singapore

Location

Related Publications (36)

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MeSH Terms

Interventions

Horticultural Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Roger CM Ho, FRCP

    National University of Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 13, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations