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Trial record 2 of 1323 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

Lifestyle Medicine for Depression

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ClinicalTrials.gov Identifier: NCT03720145
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
The Hong Kong Polytechnic University
The University of Hong Kong
University of Western Sydney
University of Melbourne
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 management of depression in Chinese adult population. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, and sleep. While lifestyle medicine has been recognized for centuries as a means to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. In the existing literature, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g, physical activities and sleep) on depression. However, there is very limited research on the effectiveness of an integration of multiple lifestyle adjustments on depression.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Lifestyle Medicine Not Applicable

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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
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
lifestyle medicine group
Behavioral: Lifestyle Medicine
Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

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 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).


Secondary Outcome Measures :
  1. 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.

  2. Change in Short form Health Survey - 36 items (SF-36) [ Time Frame: Baseline, 1-week post-treatment and 12-week post treatment ]
    SF-36 is used to assess the patients' general health and quality of life. It contains 36 items, measuring 8 aspects of health domains: physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception.

  3. Change in Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 1-week post-treatment and 12-week post treatment ]
    MFI is 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.

  4. 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

  5. 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.


Other Outcome Measures:
  1. Change in 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hong Kong residents aged ≥ 18 years;
  2. Cantonese language fluency;
  3. Patient Health Questionnaire (PHQ-9) score ≥ 10; and
  4. Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

  1. Pregnancy;
  2. Have suicidal ideation based on Beck Depression inventory (BDI-II) Item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);
  3. Using medication or psychotherapy for depression;
  4. Having unsafe conditions and are not recommended for exercising or a change in diet by physicians; and
  5. Have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification.

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): NCT03720145


Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Eliz Lam    +852 39436575    pmhlab@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
The Hong Kong Polytechnic University
The University of Hong Kong
University of Western Sydney
University of Melbourne

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Responsible Party: Fiona YY Ho, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03720145     History of Changes
Other Study ID Numbers: PSY003
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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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:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders