Lifestyle Medicine for Depression 2019
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|ClinicalTrials.gov Identifier: NCT04070417|
Recruitment Status : Not yet recruiting
First Posted : August 27, 2019
Last Update Posted : August 27, 2019
This study will examine the feasibility and efficacy of lifestyle medicine for the enhancement of psychological wellness in police officers. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, sleep and socialisation. 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.
The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on depression from a holistic body-mind perspective.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Lifestyle Medicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Treatment Group
Lifestyle Medicine Group
Behavioral: Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and socialisation
No Intervention: CAU Group
- Change in the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 1-week post-treatment and 12-week post treatment ]The PHQ-9, a 9-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).
- Change in the 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 of 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 cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
- Change in the 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.
- Change in the Short Form (Six-Dimension) Health Survey (SF-6D) [ Time Frame: Baseline, 1-week post-treatment and 12-week post treatment ]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.
- Change in the 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.
- Change in the 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.
- Change in the Credibility-Expectancy Questionnaire (CEQ) [ Time Frame: Baseline and 1-week post-treatment ]The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070417
|Contact: Janet Wong||+852 email@example.com|