Lifestyle Medicine for Depression

Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Lifestyle Medicine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Eliz Lam; Phone Number: +852 39436575; Email: pmhlab@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: CAU group; Care-As-Usual group
EXPERIMENTAL: Treatment Group; lifestyle medicine group	Behavioral: Lifestyle Medicine; Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Credibility-Expectancy Questionnaire (CEQ)	The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.	Baseline and 1-week post-treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The University of Hong Kong; The Hong Kong Polytechnic University; University of Melbourne; University of Western Sydney

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ANTICIPATED): July 31, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Lifestyle Medicine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PSY003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No