- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313542
Physical Activity in the Format of Self-defence Training for Depressive Symptoms
Effect of Physical Activity in the Format of Self-defence Training for Depressive Symptoms - A Pilot Randomised Controlled Trial
Inadequate mental health care capacity is a long-standing issue in Hong Kong (Yang & Mak, 2020). For example, a recent study predicts an additional 12% service need for specialist psychiatric care (Ni et al., 2020). It would be helpful to develop interventions that would ease the high demand of the health care system. Physical activity has been shown to reduce depressive symptoms in a number of studies (Bellón et al., 2021; Josefsson et al., 2014; Kvam et al., 2018; Schuch et al., 2016). Its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere.
This study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. Around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (PA) group and waitlist (WL) control group. The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. The primary outcome measure will be the Patient Health Questionnaire-9 to evaluate depression severity. Secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. This research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angel Lee
- Phone Number: 39436575
- Email: angellyy@link.cuhk.edu.hk
Study Locations
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Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 65 years old
- Hong Kong Residents
- Patient Health Questionnaire (PHQ-9) score ≥ 10; and
- Willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
- Patients with any cardiovascular diseases
- Receiving psychological treatment or medication for psychiatric disorders
- Participated in self defence training in the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity Group (PA group)
The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week.
Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments.
|
Physical Activity in the format of Self-defence Training
|
|
Other: Waitlist Group (WL group)
The waitlist group will receive access to the programme at the end of study.
|
Physical Activity in the format of Self-defence Training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
|
The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
|
Baseline, immediately post-intervention, 4-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
|
SF-6D is a preference-based single index measure of health.
A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
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Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version.
Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in the Insomnia Severity Index (ISI)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
|
The ISI is a 7-item scale designed to evaluate perceived insomnia severity.
Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in Hospital Anxiety and Depression Scale (HADS-14)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
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HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively.
Each item is rated on a 4-point-scale (0-3) by the participant.
The greater the score, the more psychologically distressed the respondent is.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
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The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in Credibility-Expectancy Questionnaire (CEQ)
Time Frame: Baseline, immediately post-intervention, 4-week follow-up
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The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
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Baseline, immediately post-intervention, 4-week follow-up
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Change in Treatment Adherence Survey (TAS)
Time Frame: Baseline, immediately post-intervention
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Baseline, immediately post-intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSY021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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