Lifestyle Medicine for Depression 2019

January 3, 2020 updated by: Fiona YY Ho, Chinese University of Hong Kong

Lifestyle Medicine for Depression: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Lifestyle Medicine Group
Behavioral: Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and socialisation
No Intervention: CAU Group
Care-As-Usual Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Depression Anxiety Stress Scales (DASS-21)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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
Change in the Insomnia Severity Index (ISI)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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 the Short Form (Six-Dimension) Health Survey (SF-6D)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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
Change in the Sheehan Disability Scale (SDS)
Time Frame: Baseline, 1-week post-treatment and 12-week post treatment
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 the Credibility-Expectancy Questionnaire (CEQ)
Time Frame: Baseline and 1-week post-treatment
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Baseline and 1-week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

University of Melbourne
University of Western Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

February 29, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSY007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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