Lifestyle Medicine for Depression 2019

Depression Clinical Trial

Official title:

Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04070417
• Other study ID #: PSY007
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and socialisation

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Chinese 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
Primary	Change in the Patient Health Questionnaire (PHQ-9)	The PHQ-9, a 9-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 the Depression Anxiety Stress Scales (DASS-21)	DASS-21 is a 21-items scales, comprises of 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 cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.	Baseline, 1-week post-treatment and 12-week post treatment
Secondary	Change in the 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 the Short Form (Six-Dimension) Health Survey (SF-6D)	SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.	Baseline, 1-week post-treatment and 12-week post treatment
Secondary	Change in the Health-Promoting Lifestyle Profile (HPLP II)	The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.	Baseline, 1-week post-treatment and 12-week post treatment
Secondary	Change in the 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 the 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