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出境医 / 临床实验 / Zero-time Exercise for Depression
Zero-time Exercise for Depression
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression | Behavioral: Zero-time Exercise | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | July 31, 2019 |
| Actual Study Completion Date : | August 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment group
Zero-time Exercise group
|
Behavioral: Zero-time Exercise
A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
|
| No Intervention: Waitlist group |
Outcome Measures
Primary Outcome Measures :
- Change in the Patient Health Questionnaire (PHQ-9) [ 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
Secondary Outcome Measures :
- Change in Hospital Anxiety and Depression Scale (HADS) [ 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
- Change in Insomnia Severity Index (ISI) [ 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)
- Change in Multidimensional Fatigue Inventory (MFI) [ 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
- Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C) [ 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.
- Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D) [ 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)
- Change in Sheehan Disability Scale (SDS) [ 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
- Change in Ecological momentary assessment (EMA) [ 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hong Kong residents aged 18-65 years
- Cantonese language fluency
- Patient Health Questionnaire (PHQ-9) score ≥ 10 and ≤ 14; and
- Willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
- Pregnancy;
- Have high levels of suicidal ideation (referral information to professional services will be provided);
- Unstable psychotropic drugs within 2 weeks before study entry and throughout the treatment phase;
- Current involvement in psychotherapy for depression;
- Having unsafe conditions and are not recommended for exercising by physicians; and
- Major psychiatric, medical or neurocognitive disorders that would make participation infeasible or interfere with the adherence to physical exercising.
Contacts and Locations
Locations
| Hong Kong | |
| The Chinese University of Hong Kong | |
| Sha Tin, Hong Kong | |
Sponsors and Collaborators
Chinese University of Hong Kong
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 18, 2019 | ||||
| First Posted Date ICMJE | January 22, 2019 | ||||
| Last Update Posted Date | March 11, 2020 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in the Patient Health Questionnaire (PHQ-9) [ 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
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| Original Primary Outcome Measures ICMJE |
Change in the Patient Health Questionnaire (PHQ-9) [ 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).
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Zero-time Exercise for Depression | ||||
| Official Title ICMJE | Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial | ||||
| Brief Summary | 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Behavioral: Zero-time Exercise
A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
14 | ||||
| Original Estimated Enrollment ICMJE |
40 | ||||
| Actual Study Completion Date ICMJE | August 31, 2019 | ||||
| Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Hong Kong | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03811327 | ||||
| Other Study ID Numbers ICMJE | PSY005 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Fiona YY Ho, Chinese University of Hong Kong | ||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chinese University of Hong Kong | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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