Lifestyle Medicine for Depression 2019

NCT04070417 | Unknown

• 1 other identifier: PSY007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Depression; Lifestyle Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

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

• Change in the Insomnia Severity Index (ISI)

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

• Change in the Short Form (Six-Dimension) Health Survey (SF-6D)

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

• Change in the Health-Promoting Lifestyle Profile (HPLP II)

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

• Change in the Sheehan Disability Scale (SDS)

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

Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and socialisation

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University of Melbourne: collaborator
• University of Western Sydney: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: August 26, 2019
• First Posted: August 28, 2019
• Study Start: November 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: August 1, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

HK (1)