Lifestyle Medicine for Depression

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Lifestyle Medicine


Participation Criteria
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Eligibility Criteria
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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 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); 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 modification.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>lifestyle medicine group | Behavioral: Lifestyle Medicine<br>* Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness<br>|
| No Intervention: CAU group<br>Care-As-Usual group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Patient Health Questionnaire (PHQ-9) | 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). | Baseline, 1-week post-treatment and 12-week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) | 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. | Baseline, 1-week post-treatment and 12-week post treatment | 
| Change in Short form Health Survey - 36 items (SF-36) | 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. | Baseline, 1-week post-treatment and 12-week post treatment | 
| Change in Multidimensional Fatigue Inventory (MFI) | 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. | Baseline, 1-week post-treatment and 12-week post treatment | 
| Change in Sheehan Disability Scale (SDS) | SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life | Baseline, 1-week post-treatment and 12-week post treatment | 
| Change in Depression Anxiety Stress Scales (DASS-21) | 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. | Baseline, 1-week post-treatment and 12-week post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Lifestyle Medicine