Clinical trial NCT04070417: Lifestyle Medicine for Depression 2019
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: University of Melbourne
name: University of Western Sydney
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 enhancement of psychological wellness in adult. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, sleep and socialisation. These components are weaved with psychological elements such as stress management, cognitive restructuring, motivational interviewing, and goal setting strategies that are led by clinical psychologists. While lifestyle medicine has been recognised for centuries a a mean to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. Nevertheless, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g. diet, physical activities, and sleep) on mood and stress management. With a well-researched lifestyle medicine programme adopted from Australia, the research team of the Chinese University of Hong Kong has customised the intervention protocol to fit the Chinese culture.

The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on depression from a holistic body-mind perspective.


Eligibility criteria: 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 with PHQ-9 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 physical activity 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 intervention

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 the Depression Anxiety Stress Scales (DASS-21)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in the Health-Promoting Lifestyle Profile (HPLP II)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1-week post-treatment and 12-week post treatment
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and 1-week post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: