- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308082
Programme Evaluation on Effectiveness of The Use of Movement-based x 'Elderspirituality - Fu Le Mun Sum' Intervention to Support Elderly People With Depressive Symptoms
May 8, 2023 updated by: Prof. Vivian W.Q. Lou, The University of Hong Kong
Depression is one of the most common mood disorders in old age, and yet it is frequently under-detected and under-treated.
Adopting a train-the-trainer approach, this project intends to utilize the dance movement therapy (DMT), as intervention, to support elderly people with depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the present project, two evaluation studies will be conducted.
The first study will evaluate the effectiveness of a train-the-trainer approach provided to frontline art development officers who will subsequently conduct interventions for the elderly.
A participatory train-the-trainer approach will be adopted to develop a new intervention protocol by integrating body-movement therapeutic elements and a spiritual well-being enhancement group.
In the second study, a quasi-experimental design will be adopted to examine the effectiveness of the Movement-based x 'Elderspirituality - Fu Le Mun Sum' intervention to support elderly people with depressive symptoms.
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vivian W. Q. Lou, PhD
- Phone Number: 2831-5334/3917-4835
- Email: wlou@hku.hk
Study Locations
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Hong Kong, Hong Kong, 999777
- Sau Po Centre on Ageing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years to 93 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged 60 or above
- physical mobility of at least the limbs and body
- sufficient visual and auditory abilities to complete assessments
- with a clinical diagnosis of depression or with depressive symptoms (measured as the sum of 4 dichotomous items of the Geriatric Depression Scale)
Exclusion Criteria:
- a clinical diagnosis of severe illness that led to neurological deficits which limits the participation during the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
It is proposed to have 70 participants who meet the inclusion criteria in the intervention group.
Dance movement therapy will be delivered as an intervention, which consists of six sessions: (1) Movement for Self-expression, (2) Movement for Emotional Health I, (3) Movement for Emotional Health II, (4) Movement for Connection & Creativity, (5) Embracing your Dancing Child, and (6) Movement for Self-compassion.
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The main Dance Movement Therapy (DMT) methods were dance-movement improvisations, body awareness exercises, and reflection through drawing/painting, writing, and verbalization.
There was an orientation to personal space and body awareness, interaction in pairs, and interaction in the whole group.
The themes included exploration of boundaries, somatic resources, symbols, pleasant and unpleasant emotions, mindfulness, and body awareness, enriched movement experiences, and safety and touch.
In the present study, it consists of six sessions, including (1) Movement for Self-expression, (2) Movement for Emotional Health I, (3) Movement for Emotional Health II, (4) Movement for Connection & Creativity, (5) Embracing your Dancing Child, and (6) Movement for Self-compassion.
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No Intervention: Active control group
It is proposed to have 70 participants who meet the inclusion criteria in the active control group.
Health talk will be delivered to participants which will match the length of contact and interval of contact of that in the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spirituality Scale for Chinese Elders (SSCE)
Time Frame: 4 months
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SSCE is a self-rated instrument that consists of 44 items to assess spiritual well-being among Chinese elders, covering 8 core elements: (1) meaning of life, (2) spiritual well-being, (3) transcendence, (4) relationship with self, (5) relationship with family, (6) relationship with others (friends and people around you), (7) relationship with the environment, and (8) relationship with life and death.
Responses are rated on a 5-point Likert scale with scores ranging from 0 (never) to 4 (always) to measure the frequency of a certain perception or behaviour.
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 15-item Geriatric Depression Scale (GDS-15)
Time Frame: 4 months
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It is a widely used screening instrument for depressive symptoms in the elderly.
It consists of 15 items on a checklist; the response to each statement is either "yes" or "no".
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4 months
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The 5-level EQ-5D version (EQ-5D-5L)
Time Frame: 4 months
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This is a valid and widely used scale with 6 items to measure the quality of life among the general population.
The EQ-5D-5L essentially consists of 2 facets: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, several problems, and extreme problems.
The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine"
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4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vivian W. Q. Lou, PhD, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
December 24, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 24, 2022
First Submitted That Met QC Criteria
March 24, 2022
First Posted (Actual)
April 1, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS200375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data collected in this study will be published and submitted to academic journals and as research report to share with other researchers and practitioners.
IPD Sharing Time Frame
No limitations on the publications
IPD Sharing Access Criteria
No limitations on the publications
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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