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Zero-time Exercise for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Zero-time Exercise
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Zero-time Exercise, Depression, Lifestyle, Behavioural Activation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Waitlist group

Arm Description

Zero-time Exercise group

Outcomes

Primary Outcome Measures

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). 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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
January 18, 2019
Last Updated
March 9, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03811327
Brief Title
Zero-time Exercise for Depression
Official Title
Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Zero-time Exercise, Depression, Lifestyle, Behavioural Activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Zero-time Exercise group
Arm Title
Waitlist group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Zero-time Exercise
Intervention Description
A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Change in Insomnia Severity Index (ISI)
Description
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
Title
Change in Multidimensional Fatigue Inventory (MFI)
Description
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
Title
Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Description
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
Title
Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
Description
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
Title
Change in Sheehan Disability Scale (SDS)
Description
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
Title
Change in Ecological momentary assessment (EMA)
Description
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.
Time Frame
Baseline, 1-week post-treatment and 4-week post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong

12. IPD Sharing Statement

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Zero-time Exercise for Depression

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