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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Angel Lee
- Telefonní číslo: 39436575
- E-mail: angellyy@link.cuhk.edu.hk
Studijní místa
-
-
-
Sha Tin, Hongkong
- The Chinese University of Hong Kong
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Jiný: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in the Patient Health Questionnaire (PHQ-9)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Časové okno: 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.
|
Baseline, immediately post-intervention, 4-week follow-up
|
|
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Časové okno: Baseline, immediately post-intervention, 4-week follow-up
|
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
|
|
Change in the Insomnia Severity Index (ISI)
Časové okno: 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.
|
Baseline, immediately post-intervention, 4-week follow-up
|
|
Change in Hospital Anxiety and Depression Scale (HADS-14)
Časové okno: Baseline, immediately post-intervention, 4-week follow-up
|
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
|
|
Change in Multidimensional Fatigue Inventory (MFI-20)
Časové okno: Baseline, immediately post-intervention, 4-week follow-up
|
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
|
|
Change in Credibility-Expectancy Questionnaire (CEQ)
Časové okno: Baseline, immediately post-intervention, 4-week follow-up
|
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
|
Baseline, immediately post-intervention, 4-week follow-up
|
|
Change in Treatment Adherence Survey (TAS)
Časové okno: Baseline, immediately post-intervention
|
Baseline, immediately post-intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PSY021
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Physical Activity
-
Ming-Yuan ChihDokončeno
-
Centre Hospitalier Universitaire de BesanconNáborJuvenilní idiopatická artritidaFrancie
-
The First Affiliated Hospital of Guangzhou Medical...Neznámý
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)DokončenoFyzická aktivita | Parkinsonova choroba | Zůstatek | Padající | KineziofobieKrocan
-
University of Alabama at BirminghamCenters for Disease Control and PreventionNáborRodinné vztahy | PlíseňSpojené státy
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...Nábor