NCT03720145

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

October 23, 2018

Last Update Submit

August 19, 2019

Conditions

Depression

Keywords

DepressionLifestyle Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Insomnia Severity Index (ISI)

    Baseline, 1-week post-treatment and 12-week post treatment

  • Change in Short form Health Survey - 36 items (SF-36)

    Baseline, 1-week post-treatment and 12-week post treatment

  • Change in Multidimensional Fatigue Inventory (MFI)

    Baseline, 1-week post-treatment and 12-week post treatment

  • Change in Sheehan Disability Scale (SDS)

    Baseline, 1-week post-treatment and 12-week post treatment

  • Change in Depression Anxiety Stress Scales (DASS-21)

    Baseline, 1-week post-treatment and 12-week post treatment

Other Outcomes (1)

  • Change in Credibility-Expectancy Questionnaire (CEQ)

    Baseline and 1-week post-treatment

Study Arms (2)

Treatment Group

EXPERIMENTAL

lifestyle medicine group

Behavioral: Lifestyle Medicine

CAU group

NO INTERVENTION

Care-As-Usual group

Interventions

Lifestyle MedicineBEHAVIORAL

Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy;
  • 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);
  • Using medication or psychotherapy for depression;
  • Having unsafe conditions and are not recommended for exercising 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 modification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

November 1, 2018

Primary Completion

May 31, 2019

Study Completion

July 31, 2020

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

HK(1)