Traditional Chinese medicine health preservation program for depression: program development and evaluation

Abstract

Background Depression, a debilitating mental disorder, is increasing rapidly. Hong Kong is not an exception. Targeting several lifestyle risk factors together might reduce depression. Health preservation, an important Traditional Chinese Medicine (TCM) component, includes several lifestyle-related components, has the potential to treat depression. However, evidence regarding TCM health preservation program for depression is still limited. Aim This research project purposes to develop an evidence-based TCM health preservation program for depression (named as “the Program”) and measure the Program’s feasibility, acceptance, and preliminary effectiveness on depression among Hong Kong Chinese adults with depression. Methods Guided by the updated Medical Research Council framework, this study was composed of Phase I: program development and Phase II: program evaluation. In Phase I, the Program content was generated based on several resources, established through a Delphi study, and evaluated by research team members, program providers, and local adults with depression. In Phase II, the explanatory sequential mixed methods design has been adopted. First, a two-arm parallel pilot randomized controlled trial (RCT) was carried out between April 2023 and October 2023. Forty-two participants were randomly assigned (1:1) either to the TCM health preservation program (Intervention group) or the waitlist control group (Control group). Those participants had a moderate level of depression, which was evaluated by the Patient Health Questionnaire-9 (PHQ-9). The Intervention group offered six consecutive weekly 2-hour training sessions, guiding them to implement lifestyle changes. Outcome measures included PHQ-9 for depression, Generalized Anxiety Disorder-7 for anxiety, Perceived Stress Scale for stress, Fatigue Assessment Scale for fatigue, Insomnia Severity Index for insomnia, Short Form 6-Dimension for quality of life, Health-Promoting Lifestyle Profile II for health-promoting behaviors, and General Self-Efficacy for self-efficacy. Outcome measures were assessed at baseline, mid-treatment (week 2, week 4), immediate post-treatment (week 6), post-treatment (week 8, week 12). Data analysis followed the intention-to-treat principle and utilized the generalized estimating equation (GEE). Following the RCT, a descriptive qualitative study was conducted from August 2023 to January 2024. Data collection incorporated semi-structured interviews and focus group interviews. Conventional content analysis was adopted to analyze data. Results The recruitment target of 42 patients was achieved within 94 days. The retention rate for the Program was 88.10%. The GEE indicated that the Intervention group showed significantly larger effectiveness in depression reduction at immediate post-treatment (d = 1.07, p = .004) and at 6-week post-treatment (d = 1.01, p < .001) compared to the Control group. At immediate post-treatment, the Intervention group exhibited moderate effect sizes in anxiety reduction (d = 0.76, p = .036), fatigue reduction (d = 0.74, p = .005), sleep quality improvement (d = 0.78, p = .007), health-promoting behaviors enhancement (d = 0.63, p < .001), and self-efficacy improvement (d = 0.56, p = .044). Four themes emerged: Theme 1: TCM health preservation program originally being comprehensive and special; Theme 2: TCM health preservation program being far more beneficial than thought; Theme 3: Practicing TCM health preservation having challenges; Theme 4: Strategies to promote the teaching and practice of TCM health preservation. Conclusion The mixed methods study demonstrated that the Program is a feasible, acceptable, and preliminarily efficacious for Hong Kong Chinese adults with depression. Future clinical trials with large sample sizes and long-term follow-ups are warranted to confirm the treatment effectiveness.