- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925792
Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers
Lifestyle Medicine for Enhancing Psychological Wellness in Police Officers: A Pilot Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong residents aged ≥ 18 years;
- Cantonese language fluency;
- Patient Health Questionnaire (PHQ-9) score ≥ 10; and
- Willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
- Pregnancy;
- Have suicidal ideation with PHQ-9 item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);
- Using medication or psychotherapy for depression;
- Having unsafe conditions and are not recommended for exercising or a change in diet by physicians; and
- Have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Lifestyle Medicine Group 1
|
diet, sleep, exercise and mindfulness
|
Experimental: Waitlist Control Group
Lifestyle Medicine Group 2
|
diet, sleep, exercise and mindfulness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, 1-week post-treatment and 12-week post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Anxiety Stress Scales (DASS-21)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
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+ |
Baseline, 1-week post-treatment and 12-week post treatment
|
Change in Insomnia Severity Index (ISI)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
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). |
Baseline, 1-week post-treatment and 12-week post treatment
|
Brief Resilience Scale
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
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. |
Baseline, 1-week post-treatment and 12-week post treatment
|
Short Form (Six-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
The 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.
The SF-6D index, scores from 0.0 (worst health state) to 1.0 (best health state).
|
Baseline, 1-week post-treatment and 12-week post treatment
|
Health-Promoting Lifestyle Profile (HPLP II)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
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. |
Baseline, 1-week post-treatment and 12-week post treatment
|
Change in Sheehan Disability Scale (SDS)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
SDS is a brief, 5-item self-report tool that assesses 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.
|
Baseline, 1-week post-treatment and 12-week post treatment
|
Physical activity (Fitbit Surge Fitness Superwatch)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
|
The Fitbit Surge, a commercially available accelerometer-based activity tracker, is used to examine patterns of physical activity and heart rate, objectively.
|
Baseline, 1-week post-treatment and 12-week post treatment
|
Change in Credibility-Expectancy Questionnaire (CEQ)
Time Frame: Baseline, 1-week post-treatment
|
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
|
Baseline, 1-week post-treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSY006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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