Clinical trial NCT03720145: Lifestyle Medicine for Depression
Official title: Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Lifestyle Medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
name: The University of Hong Kong
name: University of Western Sydney
name: University of Melbourne
First posted: 2018-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
Secondary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in Short form Health Survey - 36 items (SF-36)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in Depression Anxiety Stress Scales (DASS-21)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
Other outcomes:
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and 1-week post-treatment
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: