DepressionNCT06825507
Stepped Care Model of Lifestyle-based Mental Health Care for Depression
A study testing Lifestyle-based mental health care and Care-as-usual in people with Depression, run by Chinese University of Hong Kong.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Lifestyle-based mental health care and Care-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Lifestyle-based mental health care, Care-as-usual
- Keywords
- Stepped care model, Lifestyle medicine, Randomised controlled trial, Cost-effectiveness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-based mental health careBehavioural
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-usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle-based mental health care (LSC) | Experimental | Participants in the LSC will access a 6-month lifestyle-based stepped care treatment for depression. Receives: 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. Receives: Other: Care-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
- Investigators
- Fiona Yan-Yee Ho, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825507
- Sponsor's protocol ID
- PSY036
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Model of Lifestyle-based Mental Health Care for Depression: a Randomised Controlled Trial and Economic Evaluation
- ClinicalTrials.gov ID
- NCT06825507
- Acronym / sponsor ID
- PSY036
- Conditions
- Depression
- Keywords
- Stepped care model, Lifestyle medicine, Randomised controlled trial, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle-based mental health care (LSC) | Experimental | Behavioral: Lifestyle-based mental health careParticipants in the LSC will access a 6-month lifestyle-based stepped care treatment for depression. |
| Care-as-usual (CAU) | Other | Other: Care-as-usualParticipants in the CAU will have unrestricted access to mental health services based on their needs and preferences. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle-based mental health careParticipants 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). | Behavioural | Lifestyle-based mental health care (LSC) |
| Care-as-usualParticipants 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. | Other | Care-as-usual (CAU) |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
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.
9 secondary outcomes
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Baseline, immediate post-treatment, and 12-month follow-up
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, immediate post-treatment, and 12-month follow-up
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline and immediate post-treatment
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Time frame: Baseline and immediate post-treatment
Change in the EuroQol questionnaire (EQ-5D-5L)
Time frame: 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)
Time frame: Baseline, immediate post-treatment, and 12-month follow-up
Change in the Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, immediate post-treatment, and 12-month follow-up
Change in the Barriers to Access to Care Evaluation Scale Version 3 (BACE)
Time frame: 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)
Time frame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiona Yan-Yee Ho, PhD study chair
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle-based mental health care and Care-as-usual in people with Depression, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Wing-Hei Wong, PhD (39436575, vwhwong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Patient Health Questionnaire (PHQ-9) (time frame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.