| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psychological Wellbeing | Behavioral: Lifestyle Medicine | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers: A Pilot Randomised Controlled Trial |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | November 30, 2019 |
| Actual Study Completion Date : | December 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment Group
Lifestyle Medicine Group 1
|
Behavioral: Lifestyle Medicine
diet, sleep, exercise and mindfulness
|
|
Experimental: Waitlist Control Group
Lifestyle Medicine Group 2
|
Behavioral: Lifestyle Medicine
diet, sleep, exercise and mindfulness
|
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 represent mild, moderate, moderately severe and severe depression respectively.
DASS-21 is a 21-items scales, comprises three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoffs for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
Depression Anxiety Stress Normal 0-9 0-7 0-14 Mild 10-13 8-9 15-18 Moderate 14-20 10-14 19-25 Severe 21-27 15-19 26-33 Ex. Severe 28+ 20+ 34+
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.
Total score categories: 0-7 indicates no clinically significant insomnia, 8-14 refers to subthreshold insomnia,15-21 represents clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe).
The BRS, originally developed by Smith and colleagues (2008), is a 6-item questionnaire rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores represent higher level of psychological resilience. The Chinese version of the test validated by Lai & Yue (2014) has demonstrated good psychometric properties (Cronbach's alpha > .72) and were comparable to the original version developed by Smith and colleagues.
Total score divided by 6 and to be categorized: 1.00-2.99 indicates low resilience; 3.00-4.30 indicates normal resilience and 4.31-5.00 indicated high resilience.
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Items are scored as Never (N) = 1, Sometimes (S)= 2, Often (O) = 3, Routinely (R) = 4 A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. The use of means rather than sums of scale items is recommended to retain the 1 to 4 metric of item responses and to allow meaningful comparisons of scores across subscales.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Hong Kong | |
| The Chinese University of Hong Kong | |
| Hong Kong, Hong Kong | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 22, 2019 | ||||
| First Posted Date ICMJE | April 24, 2019 | ||||
| Last Update Posted Date | March 11, 2020 | ||||
| Actual Study Start Date ICMJE | June 1, 2019 | ||||
| Actual Primary Completion Date | November 30, 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 12-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 represent mild, moderate, moderately severe and severe depression respectively.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers | ||||
| Official Title ICMJE | Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers: A Pilot Randomised Controlled Trial | ||||
| Brief Summary | This study will examine the feasibility and efficacy of lifestyle medicine for the enhancement of psychological wellness in police officers. The integrative lifestyle intervention is based on the "Healthy Body Healthy Mind (HBHM)" programme developed by the University of Melbourne. It includes lifestyle psychoeducation, physical activity, nutrition and diet, relaxation/ mindfulness, and sleep. These components are weaved with psychological elements such as stress management, cognitive restructuring, motivational interviewing, and goal setting strategies that are led by clinical psychologists. While lifestyle medicine has been recognised for centuries a a mean to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. Nevertheless, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g. diet, physical activities, and sleep) on mood and stress management. With a well-researched lifestyle medicine programme adopted from Australia, the research team of the Chinese University of Hong Kong has customised the intervention protocol to fit the Chinese culture, and has conducted a pilot trial to test the protocol across different communities and work populations. The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on psychological wellness from a holistic body-mind perspective. Acknowledging that police officers are one of hte work populations with stressful work nature, it is in a hope that lifestyle medicine would be effective to facilitate stress coping and enhance the psychological wellness of police officers in the long run. | ||||
| 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: Supportive Care |
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| Condition ICMJE | Psychological Wellbeing | ||||
| Intervention ICMJE | Behavioral: Lifestyle Medicine
diet, sleep, exercise and mindfulness
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* 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 |
40 | ||||
| Original Estimated Enrollment ICMJE |
80 | ||||
| Actual Study Completion Date ICMJE | December 31, 2019 | ||||
| Actual Primary Completion Date | November 30, 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 and older (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 | NCT03925792 | ||||
| Other Study ID Numbers ICMJE | PSY006 | ||||
| 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 |
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| 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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