Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1325 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"
Previous Study | Return to List | Next Study

Lifestyle Medicine for Depression 2019

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070417
Recruitment Status : Not yet recruiting
First Posted : August 27, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
University of Melbourne
University of Western Sydney
Information provided by (Responsible Party):
Fiona YY Ho, Chinese University of Hong Kong

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Care-As-Usual Group



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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 physical activity 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Janet Wong +852 39433469 pmhlab@cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
University of Melbourne
University of Western Sydney

Layout table for additonal information
Responsible Party: Fiona YY Ho, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04070417     History of Changes
Other Study ID Numbers: PSY007
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fiona YY Ho, Chinese University of Hong Kong:
Depression
Lifestyle Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders