Mood (Psychological Function) Clinical Trial
— HTRCTOfficial title:
Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial
| Verified date | May 2016 |
| Source | National University, Singapore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: National University of Singapore |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 69 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years to 85 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Training and Research Academy; Jurong Point Shopping Centre | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National University, Singapore | National Parks Board, Singapore |
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* Note: There are 35 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Demographic questionnaire | Their social, demographic, and lifestyle data (i.e. how often they usually visit the parks or do gardening) will only be collected at baseline. This is the same for the participants' medical conditions. | Baseline | No |
| Other | Feedback questionnaire | Feedback questionnaire will be conducted to convey participants' subjective experience and thereby expanding our understanding of the impact of the horticultural therapy intervention. The survey will ask participants to identify what was the most helpful part of the class, what suggestions they have for improvement, and whether they had continued gardening and/or visiting the parks. This brief survey will only be administered once during the post-intervention assessment. Participants' responses will be informally tallied and listed in categories. | Baseline | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | Change from baseline Interleukin-1 beta (IL-1ß) at 3-months and 6-months | 10ml of fasting blood will be collected using CPT tube | baseline, 3-months, 6-months | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Change from baseline Montreal Cognitive Assessment (MoCA) at 3-months and 6-months | Montreal Cognitive Assessment (MoCA) (Nasreddine, Phillips, Bedirian, Charbonneau, Whitehead, Collin, et al., 2005) will be administered by trained research assistants and/or research nurses as global measures of cognitive function. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Clinical Dementia Rating (CDR) at 3-months and 6-months | Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3-months and 6-months | Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Digit Span Task at 3-months and 6-months | Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Colour Trails Tests (CTT) at 3-months and 6-months | Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Block Design at 3-months and 6-months | Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills. | baseline, 3-months, 6-months | No |
| Secondary | Change from baseline Semantic Verbal Fluency at 3-months and 6-months | Semantic Verbal Fluency taps lexical knowledge and semantic memory organization. | baseline, 3-months, 6-months | No |
| Secondary | Change from Basic Health Screen (composite) at 3-months and 6-months | Blood pressure, Pulse rate, Height and Weight will be measured | baseline, 3-months, 6-months | No |
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