The Chinese University of Hong Kong
Shatin, Hong Kong
NCT Number: NCT03811327
This study will examine the feasibility and effectiveness of a new lifestyle-integrated exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep disturbances, and sedentary lifestyles is associated with depression. The conventional psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT), emphasises the relationship between activity and mood. One of the treatment components in CBT for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to initiate simple behaviour change as an entry-level step for facilitating BA for participants with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the effectiveness of ZTEx for the management of depressive symptoms.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Shatin, Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
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). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purpose and not meant to be a diagnostic tool. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
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. Total score categories: 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia,15-21 is clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe)
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
IPAQ-C is a short form questionnaire assessing walking, moderate-intensity activities and vigorous-intensity activities undertaken across 4 domains - leisure time physical activity, domestic and gardening (yard) activities, work-related physical activity and transport-related physical activity. Both continuous and categorical scores can be represented. For continuous scoring, the items provide separate scores on the three specific types of activities. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of the three specific type of activities. Median minutes/week or median MET-minutes/week is derived for each type of activity - Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs. For categorical scoring, category 1 represents the lowest level of physical activity, category 2 represents moderate level of physical activity, and category 3 represents the highest level of physical activity.
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
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. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state)
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
A 5-item self-report tool for assessing functional impairment in work/school, social life, and family life. Representation of scores in terms of functional impairment: 0: not at all, 1-3: mildly, 4-6: moderately, 7-9: markedly, 10: extremely
Time frame: Baseline, 1-week post-treatment and 4-week post treatment
A smartphone application will be developed and installed in the participant's smartphones for recording the participants' momentary mood, daytime insomnia symptoms as well as activities.
Chinese University of Hong Kong
Other
Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial
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