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

NCT ID: NCT06825507

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle-based mental health care (LSC)

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

Group Type: EXPERIMENTAL

Lifestyle-based mental health care

Intervention Type: 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).

Care-as-usual (CAU)

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

Group Type: OTHER

Care-as-usual

Intervention Type: 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.

Interventions

Lifestyle-based mental health care

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).

Intervention Type: BEHAVIORAL

Care-as-usual

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assoicate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Yan-Yee Ho, PhD

Role: STUDY_CHAIR

Chinese University of Hong Kong

Central Contacts

Vincent Wing-Hei Wong, PhD

Role: CONTACT

vwhwong@cuhk.edu.hk

39436575

Other Identifiers

PSY036

Identifier Type: -

Identifier Source: org_study_id