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Physical Activity in the Format of Self-defence Training for Depressive Symptoms

Primary Purpose

Depressive Symptoms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Self Defence Training, Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physical Activity Group (PA group)

Waitlist Group (WL group)

Arm Description

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 waitlist group will receive access to the programme at the end of study.

Outcomes

Primary Outcome Measures

Change in the Patient Health Questionnaire (PHQ-9)
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).

Secondary Outcome Measures

Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
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.
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
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.
Change in the Insomnia Severity Index (ISI)
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.
Change in Hospital Anxiety and Depression Scale (HADS-14)
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.
Change in Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Change in Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Change in Treatment Adherence Survey (TAS)

Full Information

First Posted
March 29, 2022
Last Updated
July 18, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05313542
Brief Title
Physical Activity in the Format of Self-defence Training for Depressive Symptoms
Official Title
Effect of Physical Activity in the Format of Self-defence Training for Depressive Symptoms - A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Self Defence Training, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Group (PA group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Group (WL group)
Arm Type
Other
Arm Description
The waitlist group will receive access to the programme at the end of study.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Physical Activity in the format of Self-defence Training
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Secondary Outcome Measure Information:
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
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.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Description
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.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in the Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in Hospital Anxiety and Depression Scale (HADS-14)
Description
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.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in Multidimensional Fatigue Inventory (MFI-20)
Description
The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
Baseline, immediately post-intervention, 4-week follow-up
Title
Change in Treatment Adherence Survey (TAS)
Time Frame
Baseline, immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Lee
Phone
39436575
Email
angellyy@link.cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physical Activity in the Format of Self-defence Training for Depressive Symptoms

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