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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Depression

Treatments: Behavioral: Lifestyle-based mental health care; Other: Care-as-usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06825507

PSY036

Details and patient eligibility

About

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.

Enrollment: 244 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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244 participants in 2 patient groups

Lifestyle-based mental health care (LSC)

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle-based mental health care

Care-as-usual (CAU)

Other group

Description:

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

Treatment:

Other: Care-as-usual