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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Vivian W. Q. Lou, PhD
  • Phone Number: 2831-5334/3917-4835
  • Email: wlou@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 999777
        • Sau Po Centre on Ageing

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years to 91 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The 15-item Geriatric Depression Scale (GDS-15)
Time Frame: 4 months
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".
4 months
The 5-level EQ-5D version (EQ-5D-5L)
Time Frame: 4 months
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"
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tung Wah Group of Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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