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

Depressive Symptoms Clinical Trial

Official title:

Effect of Physical Activity in the Format of Self-defence Training for Depressive Symptoms - A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05313542
• Other study ID #: PSY021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: Angel Lee
• Phone: 39436575
• Email: angellyy[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Physical Activity
Physical Activity in the format of Self-defence Training

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	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.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	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.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	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.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	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.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	Change in Credibility-Expectancy Questionnaire (CEQ)	The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.	Baseline, immediately post-intervention, 4-week follow-up
Secondary	Change in Treatment Adherence Survey (TAS)		Baseline, immediately post-intervention