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临床试验/NCT02495194
NCT02495194Unknown不适用

Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial

National University of Singapore2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
69
试验地点
2
主要终点
Change from baseline Cortisol at 3-months and 6-months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

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

时间窗: baseline, 3-months, 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).

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

时间窗: baseline, 3-months, 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.

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

时间窗: baseline, 3-months, 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).

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

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

时间窗: baseline, 3-months, 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.

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

时间窗: baseline, 3-months, 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.

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

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

时间窗: baseline, 3-months, 6-months

10ml of fasting blood will be collected using CPT tube

次要结局

  • 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 Digit Span Task at 3-months and 6-months(baseline, 3-months, 6-months)
  • Change from baseline Semantic Verbal Fluency 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 Colour Trails Tests (CTT) at 3-months and 6-months(baseline, 3-months, 6-months)
  • Change from baseline Block Design at 3-months and 6-months(baseline, 3-months, 6-months)
  • Change from Basic Health Screen (composite) at 3-months and 6-months(baseline, 3-months, 6-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roger Ho Chun Man

Consultant Psychiatrist

National University of Singapore

研究点 (2)

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