Clinical trial NCT06825507: Stepped Care Model of Lifestyle-based Mental Health Care for Depression
Official title: Stepped Care Model of Lifestyle-based Mental Health Care for Depression: a Randomised Controlled Trial and Economic Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Stepped care model
Lifestyle medicine
Randomised controlled trial
Cost-effectiveness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
Secondary outcomes:
measure: Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Baseline, immediate post-treatment, and 12-month follow-up
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, immediate post-treatment, and 12-month follow-up
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediate post-treatment
measure: Change in the Treatment Acceptability and Adherence Scale (TAAS)
timeFrame: Baseline and immediate post-treatment
measure: Change in the EuroQol questionnaire (EQ-5D-5L)
timeFrame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
measure: Change in the Health Promotion Lifestyle Profile II (HPLP-II)
timeFrame: Baseline, immediate post-treatment, and 12-month follow-up
measure: Change in the Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline, immediate post-treatment, and 12-month follow-up
measure: Change in the Barriers to Access to Care Evaluation Scale Version 3 (BACE)
timeFrame: Baseline, immediate post-treatment, and 12-month follow-up
measure: Change in the the adapted version of the Trimbos and iMTA Questionnaire for Costs associated with Psychiatric Illness (TiCP)
timeFrame: Baseline, 3-month, immediate post-treatment, 9-month follow-up, and 12-month follow-ups
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Fiona Yan-Yee Ho, PhD
role: STUDY_CHAIR
References: