Stepped Care Model of Lifestyle-based Mental Health Care for Depression

NCT06825507 | Not Yet Recruiting

• 1 other identifier: PSY036
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a two-arm parallel randomised controlled trial comprising both outcome and cost-effectiveness analyses. A total of 244 eligible participants experiencing depressive symptoms will be randomly assigned to either the stepped care model of lifestyle-based mental health care (LSC) or the care-as-usual (CAU) at a 1:1 ratio. Participants in the LSC will access a stepped care treatment consisting of 3 steps, including self-help multicomponent LM treatment (Step 1), guided self-help based on the LM approach and low-intensity cognitive behavioural therapy for depression (Step 2), and specialist mental health services (Step 3). Participants in the CAU will be informed about their mental health condition and have unrestricted access to care. For the outcome analysis, the outcome assessments will include depressive symptoms, anxiety symptoms, insomnia symptoms, functional impairment, quality of life (QoL), health-promoting behaviours (HPBs), barriers to accessing mental health services, treatment acceptability, and treatment credibility and expectancy. For the cost-effectiveness analysis, the clinical outcome will be depressive symptoms and the economic outcome will be quality-adjusted life-years. Data will be collected at baseline, 3-month, 6-month (immediate post-treatment), 9-month follow-up, and 12-month follow-up assessements.

Conditions

Depression

Keywords

Stepped care model; Lifestyle medicine; Randomised controlled trial; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Change in the Patient Health Questionnaire (PHQ-9)

  The PHQ-9, a 9-item questionnaire used for screening, diagnosing, and measuring the severity of depression. Participants respond to each item on a 4-point Likert-type scale ranging from 0 (not at all) to 3 (nearly every day). The total PHQ-9 score is the sum of the scores on the 9 items and ranges from 0-27. A higher score indicates more severe depressive symptoms.

  Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups

Secondary Outcomes (9)

• Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  Baseline, immediate post-treatment, and 12-month follow-up

• Change in the Insomnia Severity Index (ISI)

  Baseline, immediate post-treatment, and 12-month follow-up

• Change in the Credibility-Expectancy Questionnaire (CEQ)

  Baseline and immediate post-treatment

• Change in the Treatment Acceptability and Adherence Scale (TAAS)

  Baseline and immediate post-treatment

• Change in the EuroQol questionnaire (EQ-5D-5L)

  Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups

Study Arms (2)

Lifestyle-based mental health care (LSC)

EXPERIMENTAL

Participants in the LSC will access a 6-month lifestyle-based stepped care treatment for depression.

Behavioral: Lifestyle-based mental health care

Care-as-usual (CAU)

OTHER

Participants in the CAU will have unrestricted access to mental health services based on their needs and preferences.

Other: Care-as-usual

Interventions

Lifestyle-based mental health care BEHAVIORAL

Participants in the LSC will access a stepped care treatment consisting of 3 steps, including self-help multicomponent LM treatment (Step 1), guided self-help based on the LM approach and low-intensity cognitive behavioural therapy for depression (Step 2), and specialist mental health services (Step 3).

Lifestyle-based mental health care (LSC)

Care-as-usual OTHER

Participants in the CAU will receive their baseline depressive symptom severity via text message following randomisation, and they will have unrestricted access to mental health services based on their needs and preferences, such as pharmacological treatments, psychological treatments, and complementary and alternative medicine.

Care-as-usual (CAU)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hong Kong residents
• Aged 18-64 years
• Able to read and understand Cantonese
• Meeting caseness on the Patient Health Questionnaire (PHQ-9) (i.e., PHQ-9 ≥10), with symptoms persisting for four weeks of watchful waiting
• Possessing an internet-enabled iOS- or Android-operated mobile device

You may not qualify if:

• Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview 7.0.2 (MINI-7)
• Having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians)
• Significant functional impairment as assessed by the Work and Social Adjustment Scale (WSAS) (i.e., WSAS ≥20)
• Unstable medication in the past two months
• Are receiving psychotherapy or other medical procedures (e.g., transcranial magnetic stimulation) for depression
• Current involvement in lifestyle modifications prescribed by medical (e.g., psychiatrist) or allied health professionals (e.g., clinical psychologists, dietitians)
• Prominent suicidal ideation or intent (i.e., non-fleeting intent or plan) as measured by the PHQ-9 item 9 score \>2 (24-hour emergency hotlines and referral information for public mental health services will be provided)
• Participating in another clinical trial
• Pregnancy
• Hospitalisation
• Unwilling to provide informed consent or comply with the research protocol

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Fiona Yan-Yee Ho, PhD

  Chinese University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Vincent Wing-Hei Wong, PhD

CONTACT

39436575; vwhwong@cuhk.edu.hk

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: Assoicate Professor

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share