Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT04917666
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Process and Outcomes of Horticultural Therapy for People With Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058611', 'term': 'Horticultural Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessors have no knowledge of whether the participants are in the treatment of control groups. They distribute and collect questionnaires from participants, and gave observation rating on the participants in both group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mental Well-being', 'timeFrame': 'Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed', 'description': 'Chinese Short Warwick-Edinburgh Mental Well-being Scale (C-SWEMWBS). The C-SWEMWBS uses a five-point Likert scale. The average scores for the scale ranges between 1 and 5, and a higher score indicates better mental well-being.'}, {'measure': 'Change in Engagement in Meaningful Activity Scale (EMAS)', 'timeFrame': 'Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed', 'description': 'Engagement in Meaningful Activity Scale (EMAS). The EMAS has 12 items measured on a four-point Likert scale. The average score for the scale is 1- 4 and a higher score indicates higher engagement.'}, {'measure': 'Change in Perceived Benefits of Horticultural Therapy', 'timeFrame': 'Pre-test, Postest (8 weeks from pre-test), Change from Pretest to Posttest is assessed', 'description': 'This is a opinion survey developed by the clinical setting to collect participants\' attitude toward horticultural therapy. It has 7 items and participants are asked to respond using a five-point scale ranging from "strongly disagree" to "strongly agree". The average score ranges from 1 to 5, and a higher score indicates that the participant perceived the benefits of horticulture therapy as higher.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['horticultural therapy', 'severe mental illness', 'care home residents'], 'conditions': ['Mental Disorders, Severe', 'Intellectual Disability']}, 'descriptionModule': {'briefSummary': 'Horticultural therapy (HT) "is the engagement of a client in horticulture activities facilitated by a trained therapist to achieve specific and documented treatment goals" (American Horticultural Therapy Association, 2012). People\'s interactions with plants, through goal-orientated horticultural activities in the form of active gardening, as well as the passive appreciation of nature, could be therapeutic to people with mental or intellectual disabilities in many ways (Eling, 2006; Parkinson, Lowe, \\& Vecsey, 2011). This study aims to conduct evaluation studies of HT group programmes for care home residents with severe mental illness.', 'detailedDescription': 'This is a randomized, single-blind, controlled study in which the outcomes of the horticultural therapy program is compared with a comparison group. Outcome measures were compared at Pre-intervention and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of severe mental disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder.\n* age 18 - 65.\n* care home resident\n\nExclusion Criteria:\n\n* organic brain disorder\n* difficulties in communication for joining horticultural activity.'}, 'identificationModule': {'nctId': 'NCT04917666', 'briefTitle': 'Process and Outcomes of Horticultural Therapy for People With Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Examining the Process and Outcomes of Horticultural Therapy for People With Severe Mental Illness, Intellectual, and Multiple Disabilities', 'orgStudyIdInfo': {'id': 'HSEARS20191030004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Participants joined a 8-session horticultural therapy group program (60 minutes per session) over 8 weeks.', 'interventionNames': ['Behavioral: Horticultural therapy']}, {'type': 'OTHER', 'label': 'Comparison', 'description': 'Participants joined 4 sessions of individual, parallel, and table-top activities of their own interest, e.g. reading, drawing, coloring.', 'interventionNames': ['Other: Comparison']}], 'interventions': [{'name': 'Horticultural therapy', 'type': 'BEHAVIORAL', 'description': 'A structured 8-session group therapy program, in which participants learn about plants, green spaces, plant-human interactions. During the program, the participants are guided by therapist to grow or take care of both indoor and outdoor plants, do small horticulture projects (like cooking, making drinks, herb projects).', 'armGroupLabels': ['Treatment']}, {'name': 'Comparison', 'type': 'OTHER', 'description': '4 session of semi-structured and free engagement in activities of their choice. The activities that they could choose are mostly table-top activities which are solitary in nature, and does not require social interaction.', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wong Chuk Hang', 'country': 'Hong Kong', 'facility': 'Tung Wah Group of Hospitals Wong Chuk Hang Complex', 'geoPoint': {'lat': 22.23981, 'lon': 114.17001}}], 'overallOfficials': [{'name': 'Andrew MH Siu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}