Lifestyle Medicine for Depression

Depression Clinical Trial

Official title:

Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720145
• Other study ID #: PSY003
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Lifestyle Medicine
Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	The Hong Kong Polytechnic University, The University of Hong Kong, University of Melbourne, University of Western Sydney

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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