NCT05313542

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

March 29, 2022

Last Update Submit

July 18, 2022

Conditions

Keywords

Self Defence TrainingPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, immediately post-intervention, 4-week follow-up

Secondary Outcomes (7)

  • Change in the Short Form (Six-Dimension) Health Survey (SF-6D)

    Baseline, immediately post-intervention, 4-week follow-up

  • Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)

    Baseline, immediately post-intervention, 4-week follow-up

  • Change in the Insomnia Severity Index (ISI)

    Baseline, immediately post-intervention, 4-week follow-up

  • Change in Hospital Anxiety and Depression Scale (HADS-14)

    Baseline, immediately post-intervention, 4-week follow-up

  • Change in Multidimensional Fatigue Inventory (MFI-20)

    Baseline, immediately post-intervention, 4-week follow-up

  • +2 more secondary outcomes

Study Arms (2)

Physical Activity Group (PA group)

EXPERIMENTAL

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.

Behavioral: Physical Activity

Waitlist Group (WL group)

OTHER

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

Behavioral: Physical Activity

Interventions

Physical Activity in the format of Self-defence Training

Physical Activity Group (PA group)Waitlist Group (WL group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with any cardiovascular diseases
  • Receiving psychological treatment or medication for psychiatric disorders
  • Participated in self defence training in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

August 31, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations