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

Stepped Care Model of Lifestyle-based Mental Health Care for Depression: a Randomised Controlled Trial and Economic Evaluation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Lifestyle-based mental health care; Other: Care-as-usual

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Wing-Hei Wong, PhD; Phone Number: 39436575; Email: vwhwong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle-based mental health care (LSC); Participants in the LSC will access a 6-month lifestyle-based stepped care treatment for depression.	Behavioral: 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).
Other: Care-as-usual (CAU); Participants in the CAU will have unrestricted access to mental health services based on their needs and preferences.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)	The GAD-7, a 7-item questionnaire will be used to assess the severity of generalised anxiety over the past 2 weeks. 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 GAD-7 score is the sum of the scores on the 7 items with a range from 0 to 21. A higher score indicates more severe generalised anxiety symptoms.	Baseline, immediate post-treatment, and 12-month follow-up
Change in the Insomnia Severity Index (ISI)	ISI is a 7-item questionnaire that uses a 5-point Likert-type scale to measure the severity of insomnia. The total ISI score is the sum of the scores on the 7 items with a range from 0 to 28. A higher score indicates more severe insomnia symptoms.	Baseline, immediate post-treatment, and 12-month follow-up
Change in the Credibility-Expectancy Questionnaire (CEQ)	The CEQ is a 6-item scale, with the sum of the first 3 items providing a measure of treatment credibility and the sum of the remaining 3 items examining treatment expectancy. Higher scores indicate greater credibility and success expectancy for the treatment.	Baseline and immediate post-treatment
Change in the Treatment Acceptability and Adherence Scale (TAAS)	The TAAS a 10-item self-report questionnaire measuring on a 7-point Likert scale that extends from 1 (disagree strongly) to 7 (agree strongly). Total scores are obtained by summing across all items after negatively worded items (3, 4, 5, 7, 8, and 10) have been reverse-scored. Scores may range from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated ability to adhere to it.	Baseline and immediate post-treatment
Change in the EuroQol questionnaire (EQ-5D-5L)	The EQ-5D-5L consists of five items that measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analogue scale (EQ-VAS) on global health. Each health dimension has five response levels, i.e., no problems, slight, moderate, severe, and extreme problems. The EQ-5D-5L health states can be converted into a single index 'utility' score using the Hong Kong population EQ-5D-5L value set with a range of 0 (death) to 1 (perfect health) (Wong et al., 2019). The EQ-VAS ranged between 0 (worst imaginable health) and 100 (best imaginable health).	Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
Change in the Health Promotion Lifestyle Profile II (HPLP-II)	HPLP-II is a 52-item questionnaire scored on a 4-point Likert-type scale ranging from 1 (never) to 4 (routinely). The HPLP-II measures the overall health-promoting lifestyle and 6 subdomains of HPBs, which include health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. The overall health-promoting lifestyle score is the sum of the scores on the 52 items with a range from 52 to 208, whereas the score of each subdomain is the sum of the scores on the specific items (8 or 9 items) within that subdomain with a range from 8-32 or 9-36. A higher score indicates more HPBs.	Baseline, immediate post-treatment, and 12-month follow-up
Change in the Work and Social Adjustment Scale (WSAS)	WSAS is a 5-item self-report scale that aims to evaluate impairment in function in terms of work, home management, social leisure, private leisure, and personal or family relationships (Mundt et al., 2002). The total score is the sum of the scores on the 5 items with a range from 0-40, of which 0-9 will be categorised as low impairment, 10-19 will be categorised as moderate impairment, and 20-40 will be categorised as severe impairment.	Baseline, immediate post-treatment, and 12-month follow-up
Change in the Barriers to Access to Care Evaluation Scale Version 3 (BACE)	The BACE is a 30-item questionnaire designed to assess perceived obstacles, including practical, socioeconomic, attitudinal, and structural barriers, related to accessing mental health services. Participants respond to each item on a 4-point Likert scale from 0 (not a challenge) to 3 (a lot of challenge). The total BACE score is the sum of the 30 items with a range from 0-90. A higher score represents greater perceived barriers to receiving mental health services.	Baseline, immediate post-treatment, and 12-month follow-up
Change in the the adapted version of the Trimbos and iMTA Questionnaire for Costs associated with Psychiatric Illness (TiCP)	The TiCP is a self-report questionnaire designed to estimate the direct healthcare costs and productivity costs related to mental disorders. The TiCP assesses participants' utilisation of various healthcare services and their frequency in the past three months, which includes all types of visits to primary care (e.g., general practitioner, physiotherapist) and secondary care (e.g., medical specialist, psychologist or psychiatrist, hospital admission), medication costs, and informal care (i.e., by informal caregivers such as relatives, friends, and neighbours) they received. Additionally, information on participants' workplace absenteeism and/or reduction in productivity in paid or unpaid work due to mental health illnesses in the past month will also be collected.	Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Chair: Fiona Yan-Yee Ho, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Cost-effectiveness; Stepped care model; Lifestyle medicine
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PSY036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No