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
|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|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Treatment Group
lifestyle medicine group
Behavioral: Lifestyle Medicine
Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness
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 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).
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
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
|The Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Eliz Lam +852 39436575 firstname.lastname@example.org|