Skip to content

Lifestyle Medicine for Depression

Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03720145
Enrollment
30
Registered
2018-10-25
Start date
2018-11-01
Completion date
2020-07-31
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Lifestyle Medicine

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.

Interventions

Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

Sponsors

The Hong Kong Polytechnic University
CollaboratorOTHER
The University of Hong Kong
CollaboratorOTHER
University of Western Sydney
CollaboratorOTHER
University of Melbourne
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the Patient Health Questionnaire (PHQ-9)Baseline, 1-week post-treatment and 12-week post treatmentThe 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

MeasureTime frameDescription
Change in Insomnia Severity Index (ISI)Baseline, 1-week post-treatment and 12-week post treatmentISI 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)Baseline, 1-week post-treatment and 12-week post treatmentSF-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 Sheehan Disability Scale (SDS)Baseline, 1-week post-treatment and 12-week post treatmentSDS 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)Baseline, 1-week post-treatment and 12-week post treatmentDASS-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 Multidimensional Fatigue Inventory (MFI)Baseline, 1-week post-treatment and 12-week post treatmentMFI 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.

Other

MeasureTime frameDescription
Change in Credibility-Expectancy Questionnaire (CEQ)Baseline and 1-week post-treatmentThe 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026