Depression in Old AgeNCT05308082
Programme Evaluation on Effectiveness of The Use of Movement-based x 'Elderspirituality - Fu Le Mun Sum' Intervention to Support Elderly People With Depressive Symptoms
A study testing Dance Movement Therapy (DMT) in people with Depression in Old Age, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- Dance Movement Therapy (DMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2021to 30 Dec 2022
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- a clinical diagnosis of severe illness that led to neurological deficits which limits the participation during the intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression in Old Age
- Being tested
- Dance Movement Therapy (DMT)
- Keywords
- Depression, Dance Movement Therapy, Depressive symptoms, Older adults, Elderly, Ageing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Movement Therapy (DMT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Dance Movement Therapy (DMT) |
| Active control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirituality Scale for Chinese Elders (SSCE)
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.
Measured: 4 months
Secondary outcomes (2)
The 15-item Geriatric Depression Scale (GDS-15)
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".
Measured: 4 months
The 5-level EQ-5D version (EQ-5D-5L)
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"
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Mar 2021
- Primary completion24 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is proposed that a total of 140 participants will be recruited, with 70 assigned to the intervention group, and 70 to the active control group. For 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. For the intervention group, dance movement therapy will be delivered on a regular basis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Responsible party
- Principal investigator, Prof. Vivian W.Q. Lou, The University of Hong Kong
- Investigators
- Vivian W. Q. Lou, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308082
- Sponsor's protocol ID
- RS200375
- Status last verified
- May 2023
- First submitted
- 24 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this study will be published and submitted to academic journals and as research report to share with other researchers and practitioners.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programme Evaluation on Effectiveness of The Use of Movement-based x 'Elderspirituality - Fu Le Mun Sum' Intervention to Support Elderly People With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05308082
- Acronym / sponsor ID
- RS200375
- Conditions
- Depression in Old Age
- Keywords
- Depression, Dance Movement Therapy, Depressive symptoms, Older adults, Elderly, Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is proposed that a total of 140 participants will be recruited, with 70 assigned to the intervention group, and 70 to the active control group. For 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. For the intervention group, dance movement therapy will be delivered on a regular basis.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dance Movement Therapy (DMT)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. |
| Active control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- a clinical diagnosis of severe illness that led to neurological deficits which limits the participation during the intervention
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 |
|---|---|---|
| Dance Movement Therapy (DMT)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. | Behavioural | Intervention group |
Primary outcome
Spirituality Scale for Chinese Elders (SSCE)
Time frame: 4 months
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.
2 secondary outcomes
The 15-item Geriatric Depression Scale (GDS-15)
Time frame: 4 months
The 5-level EQ-5D version (EQ-5D-5L)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Yes. Data collected in this study will be published and submitted to academic journals and as research report to share with other researchers and practitioners.
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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.
Vivian W. Q. Lou, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Movement Therapy (DMT) in people with Depression in Old Age, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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: finished, as of the sponsor's last update on 9 May 2023. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spirituality Scale for Chinese Elders (SSCE) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.