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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Vincent Wing-Hei Wong, PhD contact

39436575

vwhwong@cuhk.edu.hk

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 groups in NCT06825507
Study groupRoleWhat they receive
Lifestyle-based mental health care (LSC)ExperimentalParticipants 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)OtherParticipants 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.

  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.

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

Secondary outcomes (9)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted13 Feb 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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)
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

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.

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