Mood (Psychological Function)HTRCTNCT02495194
Effects of Horticultural Therapy on Asian Elderly' Mental Health
A study testing Horticultural Therapy in people with Mood (Psychological Function), run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mood (Psychological Function)
- What is being tested?
- Horticultural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Training and Research Academy; Jurong Point Shopping Centre
Singapore, Singapore, 460077
About this study
Official title: Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Mood (Psychological Function)
- Being tested
- Horticultural Therapy
- Keywords
- Promotion of psychological well-being, Horticultural therapy, Randomized Controlled Trial, Gardening, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Horticultural Therapy |
| Waitlist Control Group | Other | Participants will receive the same horticultural therapy program at the end of the assessments Receives: Behavioral: Horticultural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 3-months, 6-months
Secondary outcomes (8)
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.
Measured: baseline, 3-months, 6-months
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.
Measured: baseline, 3-months, 6-months
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.
Measured: baseline, 3-months, 6-months
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.
Measured: baseline, 3-months, 6-months
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.
Measured: baseline, 3-months, 6-months
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.
Measured: baseline, 3-months, 6-months
Change from baseline Semantic Verbal Fluency at 3-months and 6-months
Semantic Verbal Fluency taps lexical knowledge and semantic memory organization.
Measured: baseline, 3-months, 6-months
Change from Basic Health Screen (composite) at 3-months and 6-months
Blood pressure, Pulse rate, Height and Weight will be measured
Measured: baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Mood (Psychological Function)Studies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Parks Board, Singapore
- Responsible party
- Principal investigator, Roger Ho Chun Man, National University of Singapore
- Investigators
- Roger CM Ho, FRCP, Principal investigator, National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495194
- Sponsor's protocol ID
- B-15-016
- Acronym
- HTRCT
- Status last verified
- May 2016
- First submitted
- 24 Jun 2015
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aydemir C, Yalcin ES, Aksaray S, Kisa C, Yildirim SG, Uzbay T, Goka E. Brain-derived neurotrophic factor (BDNF) changes in the serum of depressed women. Prog Neuropsychopharmacol Biol Psychiatry. 2006 Sep 30;30(7):1256-60. doi: 10.1016/j.pnpbp.2006.03.025. Epub 2006 May 2.
PubMed 16647794Barnicle, T., & Midden, K. S. (2003). The effects of a horticulture activity program on the psychological well-being of older people in a long-term care facility. HortTechnology, 13(1), 81-85.
Baune BT, Smith E, Reppermund S, Air T, Samaras K, Lux O, Brodaty H, Sachdev P, Trollor JN. Inflammatory biomarkers predict depressive, but not anxiety symptoms during aging: the prospective Sydney Memory and Aging Study. Psychoneuroendocrinology. 2012 Sep;37(9):1521-30. doi: 10.1016/j.psyneuen.2012.02.006. Epub 2012 Mar 9.
PubMed 22406002BOARD F, PERSKY H, HAMBURG DA. Psychological stress and endocrine functions; blood levels of adrenocortical and thyroid hormones in acutely disturbed patients. Psychosom Med. 1956 Jul-Aug;18(4):324-33. doi: 10.1097/00006842-195607000-00006. No abstract available.
PubMed 13350458Brunoni AR, Lopes M, Fregni F. A systematic review and meta-analysis of clinical studies on major depression and BDNF levels: implications for the role of neuroplasticity in depression. Int J Neuropsychopharmacol. 2008 Dec;11(8):1169-80. doi: 10.1017/S1461145708009309. Epub 2008 Aug 28.
PubMed 18752720Chu, C. M., & Simpson, R. (1994). Ecological public health: from vision to practice. Centre for Health Promotion, University of Toronto: ParticipACTION.
Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.
PubMed 20015486Gervasoni N, Aubry JM, Bondolfi G, Osiek C, Schwald M, Bertschy G, Karege F. Partial normalization of serum brain-derived neurotrophic factor in remitted patients after a major depressive episode. Neuropsychobiology. 2005;51(4):234-8. doi: 10.1159/000085725. Epub 2005 May 12.
PubMed 15897674GIBBONS JL. CORTISOL SECRETION RATE IN DEPRESSIVE ILLNESS. Arch Gen Psychiatry. 1964 Jun;10:572-5. doi: 10.1001/archpsyc.1964.01720240026004. No abstract available.
PubMed 14159257GIBBONS JL, McHUGH PR. Plasma cortisol in depressive illness. J Psychiatr Res. 1962 Sep;1:162-71. doi: 10.1016/0022-3956(62)90006-7. No abstract available.
PubMed 13947658Gonzalez MT, Hartig T, Patil GG, Martinsen EW, Kirkevold M. A prospective study of existential issues in therapeutic horticulture for clinical depression. Issues Ment Health Nurs. 2011;32(1):73-81. doi: 10.3109/01612840.2010.528168.
PubMed 21208054Gonzalez MT, Hartig T, Patil GG, Martinsen EW, Kirkevold M. Therapeutic horticulture in clinical depression: a prospective study of active components. J Adv Nurs. 2010 Sep;66(9):2002-13. doi: 10.1111/j.1365-2648.2010.05383.x. Epub 2010 Jul 2.
PubMed 20626473Grahn, P., & Stigsdotter, U. A. (2003). Landscape planning and stress. Urban forestry & urban greening, 2(1), 1-18.
Hancock, T. (1999). Health care reform and reform for health: creating a health system for communities in the 21st century. Futures, 31(5), 417-436.
Hartig, T., Evans, G. W., Jamner, L. D., Davis, D. S., & Gärling, T. (2003). Tracking restoration in natural and urban field settings. Journal of environmental psychology, 23(2), 109-123.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Horticultural Therapy on Asian Elderly' Mental Health: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02495194
- Acronym / sponsor ID
- HTRCT / B-15-016
- Conditions
- Mood (Psychological Function)
- Keywords
- Promotion of psychological well-being, Horticultural therapy, Randomized Controlled Trial, Gardening, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Parks Board, Singapore
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Horticultural Therapy | Experimental | Behavioral: Horticultural Therapy15 sessions of Horticultural Therapy program teaching the elderly about gardening techniques and for them to benefit from the therapeutic effects of the parks |
| Waitlist Control Group | Other | Behavioral: Horticultural TherapyParticipants will receive the same horticultural therapy program at the end of the assessments |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horticultural TherapyThe 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 | Behavioural | Active Horticultural Therapy, Waitlist Control Group |
Primary outcome
Change from baseline Zung Self-Rating Depression Scale (SDS) at 3-months and 6-months
Time frame: 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 Zung Self-Rating Anxiety Scale (SAS) at 3-months and 6-months
Time frame: 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
Time frame: 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 Satisfaction with Life Scale (SWLS) at 3-months and 6-months
Time frame: 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
Time frame: 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 Interleukin 6 (IL-6) at 3-months and 6-months
Time frame: baseline, 3-months, 6-months
10ml of fasting blood will be collected using CPT tube
Change from baseline Interleukin-1 beta (IL-1β) at 3-months and 6-months
Time frame: baseline, 3-months, 6-months
10ml of fasting blood will be collected using CPT tube
Change from baseline C-reactive protein (CRP) at 3-months and 6-months
Time frame: baseline, 3-months, 6-months
10ml of fasting blood will be collected using CPT tube
Change from baseline Cortisol at 3-months and 6-months
Time frame: 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
Time frame: 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
Time frame: baseline, 3-months, 6-months
10ml of fasting blood will be collected using CPT tube
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Background: PubMed 16647794Aydemir C, Yalcin ES, Aksaray S, Kisa C, Yildirim SG, Uzbay T, Goka E. Brain-derived neurotrophic factor (BDNF) changes in the serum of depressed women. Prog Neuropsychopharmacol Biol Psychiatry. 2006 Sep 30;30(7):1256-60. doi: 10.1016/j.pnpbp.2006.03.025. Epub 2006 May 2.
- BackgroundBarnicle, T., & Midden, K. S. (2003). The effects of a horticulture activity program on the psychological well-being of older people in a long-term care facility. HortTechnology, 13(1), 81-85.
- Background: PubMed 22406002Baune BT, Smith E, Reppermund S, Air T, Samaras K, Lux O, Brodaty H, Sachdev P, Trollor JN. Inflammatory biomarkers predict depressive, but not anxiety symptoms during aging: the prospective Sydney Memory and Aging Study. Psychoneuroendocrinology. 2012 Sep;37(9):1521-30. doi: 10.1016/j.psyneuen.2012.02.006. Epub 2012 Mar 9.
- Background: PubMed 13350458BOARD F, PERSKY H, HAMBURG DA. Psychological stress and endocrine functions; blood levels of adrenocortical and thyroid hormones in acutely disturbed patients. Psychosom Med. 1956 Jul-Aug;18(4):324-33. doi: 10.1097/00006842-195607000-00006. No abstract available.
- Background: PubMed 18752720Brunoni AR, Lopes M, Fregni F. A systematic review and meta-analysis of clinical studies on major depression and BDNF levels: implications for the role of neuroplasticity in depression. Int J Neuropsychopharmacol. 2008 Dec;11(8):1169-80. doi: 10.1017/S1461145708009309. Epub 2008 Aug 28.
- BackgroundChu, C. M., & Simpson, R. (1994). Ecological public health: from vision to practice. Centre for Health Promotion, University of Toronto: ParticipACTION.
- Background: PubMed 20015486Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.
- Background: PubMed 15897674Gervasoni N, Aubry JM, Bondolfi G, Osiek C, Schwald M, Bertschy G, Karege F. Partial normalization of serum brain-derived neurotrophic factor in remitted patients after a major depressive episode. Neuropsychobiology. 2005;51(4):234-8. doi: 10.1159/000085725. Epub 2005 May 12.
- Background: PubMed 14159257GIBBONS JL. CORTISOL SECRETION RATE IN DEPRESSIVE ILLNESS. Arch Gen Psychiatry. 1964 Jun;10:572-5. doi: 10.1001/archpsyc.1964.01720240026004. No abstract available.
- Background: PubMed 13947658GIBBONS JL, McHUGH PR. Plasma cortisol in depressive illness. J Psychiatr Res. 1962 Sep;1:162-71. doi: 10.1016/0022-3956(62)90006-7. No abstract available.
- Background: PubMed 21208054Gonzalez MT, Hartig T, Patil GG, Martinsen EW, Kirkevold M. A prospective study of existential issues in therapeutic horticulture for clinical depression. Issues Ment Health Nurs. 2011;32(1):73-81. doi: 10.3109/01612840.2010.528168.
- Background: PubMed 20626473Gonzalez MT, Hartig T, Patil GG, Martinsen EW, Kirkevold M. Therapeutic horticulture in clinical depression: a prospective study of active components. J Adv Nurs. 2010 Sep;66(9):2002-13. doi: 10.1111/j.1365-2648.2010.05383.x. Epub 2010 Jul 2.
Related trials for Mood (Psychological Function)
RecruitingPhase 1/2
Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Mood (Psychological Function), Well Being
Not yet recruiting
Two Sessions of Coach-Delivered Core Transformation for Distress and Well-Being
Psychological Distress, Psychological Well-being
Not yet recruiting
Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders
Bipolar Disorder, Bipolar and Related Disorders
Recruiting
Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood
Stress, Psychological Factors
Recruiting
Probiotic Intake and Perimenopausal Psychological Assessments
Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations, Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger CM Ho, FRCP principal investigator
National University of Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horticultural Therapy in people with Mood (Psychological Function), run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Zung Self-Rating Depression Scale (SDS) at 3-months and 6-months (time frame: baseline, 3-months, 6-months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495194, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.