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

Overview

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.

Interventions

• 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
  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.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06825507 · PSY036

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗