Introduction
Background and rationale
Depression is a major global health problem. According to estimates from the WHO,1 approximately 4.4% of the global population suffers from depression, with the elderly facing a heightened risk compared with other age groups. In China, which has a substantial ageing population, the population aged 60 and above reached 264.02 million by the end of 2020, and within this demographic, rural elderly constituted approximately 45.97%.2 A national epidemiological study3 revealed that the prevalence of depression among China’s elderly reached 31.73%, highlighting that over 83 million elderly individuals in China experience depressive symptoms. Moreover, the prevalence of depressive symptoms among rural elderly is 1.7 times greater than that observed in urban elderly, reaching 35.1%.4 Depressive symptoms can lead to an array of adverse health consequences, including compromised quality of life, cognitive decline, an elevated risk of heart disease, mortality associated with illnesses and even suicide.5–8 Additionally, depressive symptoms significantly escalate the need for medical care and the ensuing expenditures for China’s rural elderly, contributing to 47.26% of total expected personal medical expenditures.9 Consequently, this burden extends to families and society at large. Hence, the prevalence of depressive symptoms among China’s rural elderly constitutes a pressing challenge that demands immediate attention.
The two primary treatment approaches for depressive symptoms are pharmacotherapy and psychotherapy. Psychotherapy, noted for its enduring effects, provides prolonged benefits compared with pharmacotherapy.10 11 Meanwhile, a systematic review and meta-analysis of 366 trials12 demonstrated that psychotherapy exhibits the most substantial effect size in addressing depressive symptoms among the elderly, surpassing its efficacy in other age groups, with the exception of young adults. Behavioural activation treatment (BAT), a component of cognitive behavioural therapy, has been confirmed to be a straightforward, brief, low-cost, safe and effective intervention to counteract the typical negativity, pessimism, withdrawal, avoidance and inactivity that characterise depressive symptoms.13 14 It posits that increased engagement in pleasurable activities elevates positive affect, leading to a reduction in depressive symptoms.15 However, BAT was limited by its inability to conduct a comprehensive functional analysis, particularly in terms of selecting activities closely aligned with personal values.16 The modified behavioural activation treatment (MBAT), an adaptation of the brief behavioural activation treatment, has been recognised for addressing depressive symptoms. In comparison to BAT, MBAT offers several advantages: (a) a heightened focus on treatment rationale; (b) increased clarity concerning life areas, values and activities; (c) simplified treatment forms; (d) enhanced procedural details and (e) the provision of a revised daily monitoring form tailored for individuals with lower literacy levels. Recent studies from developed countries have shown promising outcomes with the implementation of MBAT in primary care services for treating depression, with strong adherence to treatment and acceptability observed.17–19 Despite the considerable potential of MBAT to aid rural elderly with depressive symptoms, there remains limited empirical evidence supporting its practical application in China. Furthermore, therapeutic manuals designed to address geriatric depressive symptoms are currently unavailable.
The management of geriatric depressive symptoms in rural China presents greater challenges than those faced in developed countries. A major reason is the limited expertise of primary medical staff in township hospitals (THs) in delivering mental health service. For a considerable duration, high-quality psychological service resources have been predominantly concentrated in large hospitals. As providers of rural primary care, THs play a vital role in the rural tertiary care network, yet they face difficulties in attracting quality mental health resources and professionals. Our previous trial demonstrated the significant efficacy of MBAT in alleviating depressive symptoms among rural elderly compared with usual care.20 However, it is important to note that the intervention team for that trial consisted of psychologists from tertiary hospitals, which limited the programme’s scalability and did not fundamentally address the issue of depressive symptoms in rural elderly populations. Moreover, most primary medical staff exhibited a pessimistic and negative attitude toward mental health services for patients with mental illness,21 and a substantial gap exists between the demand for psychotherapy among the rural elderly and the psychological service capabilities of primary medical staff.22 23 Given the increasing demand for care in geriatric depressive symptoms, there is an urgent need to enhance the management capacity of primary medical staff in China to foster the development of mental health services for rural elderly. The comprehensive mobilisation of primary health resources has become essential to tackle this issue. In light of the absence of systematic mental health training programmes for primary medical staff, the development of an effective training programme is crucial to strengthen primary mental health services and improve depressive symptoms among the rural elderly. Although some domestic studies have developed mental health training programmes targeting community healthcare workers in urban and city areas,24 25 and in 2020, the Chinese government began organising mental health training programmes for primary medical staff with basic mental health education as the training content in some pilot sites,26 there remains a lack of mental health training programmes specifically for managing geriatric depressive symptoms in rural areas.
In rural China, primary healthcare services are provided under a contract responsibility system. The THs are the cornerstone of the three-tier health service network in rural areas. A designated primary medical staff member leads village doctors in conducting monthly health screenings for the elderly within their jurisdiction and reports the results to the county-level health departments via a network platform dedicated to geriatric check-up data. Given the ease of adopting MBAT and the current absence of mental health training programmes for primary medical staff, we propose to develop an MBAT training programme specifically for primary medical staff from THs. This programme will build on our previous work to address their training needs and provide them with systematic training. Subsequently, primary medical staff who successfully pass the training assessment will implement the MBAT programme for rural elderly with depressive symptoms. This initiative aims to establish a ‘take-home’ mental health support team, offering immediate mental health services to the rural elderly.
Objectives
The study aims to develop an MBAT training programme for primary medical staff and to evaluate the effectiveness of this programme in managing depressive symptoms among rural elderly.
Methods and analysis
Study design
A cluster randomised controlled trial with blinded outcome assessment will be conducted to evaluate the effectiveness of the MBAT training programme (figure 1). The protocol follows the SPIRIT 2013 checklist.27 Recruitment will begin on 1 August 2024 and conclude on 31 December 2025. The methods for developing the MBAT training programme are detailed in Supplementary material, online supplemental appendix 1.
Supplemental material
Trial procedures flow diagram.
Study setting
Hunan Province serves as a geographical representative of Central China. According to the Communiqué of the Seventh National Population Census of China,2 Hunan was one of the most populous provinces in China, ranking seventh in elderly population size and exhibiting the highest degree of ageing nationwide. Moreover, the province witnesses a significant migration of young people from rural areas, exemplifying a common trend in China’s population ageing phenomenon. These demographic trends make Hunan Province a quintessential example of the ageing population issues faced by central regions in China. Two cities from the central part of Hunan Province, Lengshuijiang City and Lianyuan City, will be selected as research sites. They serve to represent the primary health service level and the distribution of the elderly population in Hunan Province. According to official government statistics, in 2020, the proportion of individuals aged 60 and above was at 21.5% in Lengshuijiang City and 19.3% in Lianyuan City, closely resembling the elderly population ratio of 19.9% in Hunan province.
Participants
In each selected TH, we will recruit 2–3 primary medical staff members using convenience sampling. The inclusion criteria for primary medical staff are those who (i) are aged 18 years or older; (ii) are responsible for health services for the elderly working at the sample sites; (iii) have been engaged in primary medical work for at least 6 months; (ⅳ) have not participated in any systematic psychological training and (ⅴ) voluntarily agree to participate in this programme. Those who suffer from mental illnesses will be excluded.
The rural elderly who meet the following inclusion criteria will be recruited for the MBAT intervention: (i) aged over 60 years; (ii) with scores between 11 and 25 on the Geriatric Depression Scale (GDS)28; (iii) without psychiatric or medical comorbidities that are potentially life-threatening or could severely restrict participation or adherence; (ⅳ) and are not currently undergoing therapy with a cognitive–behavioural therapist, psychotherapist or counsellor, including those currently on antidepressant medication. Those rural elderly with cognitive dysfunction (screening tool: Mini-Mental State Examination, score <27) or communication impairments will be excluded. If two elders meet the above inclusion criteria and are willing to participate from the same family, then the one with the higher GDS score will be recruited. Note that during screening, the implementation of MBAT interventions or follow-up, primary medical staff will contact our team member for professional consultation on identifying a GDS assessment score greater than 25, and then assist the team member in referring patients to higher-level hospitals for further treatment.
Sample size
The sample size for this cluster randomised controlled trial will be determined based on the primary outcome, which is the ‘depression symptom score’ assessed using GDS. In our previous study,20 a significant reduction of 2.16 points in the GDS score was observed in the MBAT intervention group post-intervention, compared with the baseline, with a pooled SD of 2.339 and a Cohen’s d of 0.694. Considering the randomisation of THs, the intraclass correlation coefficient (ICC) will be accounted for in adjusting the sample size. In this study, there are 10 THs in Lengshuijiang City and 21 THs in Lianyuan City, resulting in a maximum cluster number of 15 per arm. In a prior study conducted by Hemming et al,29 it was determined that to achieve a power of 80%, the ICC should not exceed 0.06 when the effect sizes are greater than 0.25 and there are 10 to 20 clusters per arm. Thus, we set the ICC at 0.06 for this study. Subsequently, sample-size calculations were performed using PASS 2021, employing generalised estimating equations (GEEs) for two means in a cluster-randomised design. To achieve a minimum of 90% statistical power at a 5% significance level, and accounting for an anticipated follow-up loss rate of 25%,30 the total sample size required is 150. This includes 5 clusters per arm, with each cluster comprising 15 subjects, thereby achieving a maximum power of 95.06%. Thus, we will aim for a total of 150 participants overall, with 5 THs selected for each group, each TH comprising 15 participants.
Recruitment
After consultation and agreement with the Division of Ageing and Health of the Hunan Provincial Health Planning Commission and the local Health Bureau, we will recruit potential primary medical staff to participate in the MBAT training programme. Once they have completed the training, these qualified staff members will screen for depressive symptoms among rural elderly residents in their jurisdiction. The rural elderly with depressive symptoms who meet the inclusion criteria will be identified as potential participants for this study. They will be informed of opportunities to join this MBAT programme and will receive a comprehensive explanation of its details. For those eligible participants expressing interest in the programme, detailed written materials about the programme and their rights and risks as participants will be provided. Moreover, written informed consent will be obtained from each participant. All participants will be informed that they can withdraw from the study at any time. Should they choose to withdraw, the primary medical staff will document the reasons for this decision.
Randomization and allocation concealment
There are 10 THs in Lengshuijiang City and 21 in Lianyuan City. We will analyse the population distribution and primary service resources of these two cities and randomly select 4 and 6 THs from Lengshuijiang and Lianyuan City, respectively, using a random number generator (https://stattrek.com/statistics/random-number-generator). The THs selected from each city will then be randomly assigned to either the intervention or control groups at a 1:1 ratio, using computer-generated random numbers. After screening for depressive symptoms by trained primary medical staff, all eligible rural elderly residents in the areas managed by the intervention THs will be potential intervention participants, and those in areas managed by the control THs will be potential control participants. We will randomly select 15 participants from all eligible rural elderly participants within each selected TH. A biostatistician, who will not be involved in the study intervention or data analysis, will be invited to conduct the randomisation.
Blind
Individual participants will not be blinded to the intervention they receive. The assigned researchers and statisticians, who will only be involved in the data collection and analysis phases, will be blinded regarding group assignments. The primary medical staff will each be informed about the nature of the intervention; however, to maintain the integrity of the blinded study design, they will not receive information regarding the assignments of other staff members or the specific distribution of participants among the groups. Meanwhile, the trained evaluators will be blinded to the nature of the participants.
Intervention
Participants will be enrolled for a duration of 12 months. During this period, three main phases will be conducted as follows: training the eligible primary medical staff (8 weeks), screening for depressive symptoms among the rural elderly by trained primary medical staff (2 months) and implementing one‐to‐one, face to face interventions for the eligible rural elderly participants (2 months). The timeline for the intervention activities is shown in figure 2. In this study, the considerable spatial separation between each TH and the lack of transparency in the interventions for each group may help to mitigate cross-contamination between distinct clusters within the experimental and control groups. The specific interventions for the rural elderly with depressive symptoms will be detailed subsequently.
The intervention activity timeline. A brief explanation for Figure 2: S-1 to S-8: MBAT Session; I-1 to I-3: MBAT Training Programme; I-1: Training the eligible primary medical staff with MBAT for 8 weeks; I-2: Screening for depressive symptoms among the rural elderly by trained primary medical staff for 2 months; I-3: Implementing one‐to‐one, face to face MBAT interventions for the eligible rural elderly participants for 2 months; C-1 to C-3: Usual Care Training Programme; C-1: Training the eligible primary medical staff with usual care for 8 weeks; C-2: Screening for depressive symptoms among the rural elderly by trained primary medical staff for 2 months; C-3: Implementing one‐to‐one, face to face usual care interventions for the eligible rural elderly participants for 2 months; I-C1 to I-C6 & C-C1 to C-C6: Six booster telephone sessions; T-0 to T-3: Effect evaluation of participants; ●: Faculty assessments. MBAT, modified behavioural activation treatment.
Intervention group
The intervention group will recruit 2–3 primary medical staff at each TH to participate in the MBAT training programme. This programme will be developed using the semi-structured interviews for training needs analysis, group discussions to establish the training checklist and the Delphi method to validate its rationale, scientific basis and feasibility. The content of MBAT training needs may include training objectives, priorities, setting, time, methods, course schedule, duration, frequency, testing, expectations and attitudes. The programme includes three main parts: MBAT training (including faculty assessments), screening and intervention (including follow-up). A team of psychological rehabilitation professionals from tertiary hospitals will train the recruited primary medical staff using the MBAT training programme, which will include both a theoretical curriculum and practical skills practice. The primary medical staff must pass both a theoretical assessment and a practical skills assessment before they are qualified to implement the MBAT. Then, they will provide MBAT interventions along with standardised usual care. The initial content of the MBAT includes eight sessions (table 1),20 with each session lasting 2 hours over an 8-week period. The scheduling and timing of interventions ensure consistency for participants. Following the 8-week sessions, the primary medical staff will provide telephone-based follow-up services to address issues related to MBAT.
The initial content of the MBAT
Control group
Like the intervention group, the control group will also recruit 2–3 primary medical staff in each TH to participate in the usual care training programme instead of the MBAT training programme. This programme will be provided by a team of psychological rehabilitation professionals from tertiary hospitals. According to the national grassroots personnel training programme,26 the usual care training programme comprises six modules: basic mental health knowledge, education, problem identification, interpersonal communication, stress management and psychological rehabilitation management. After successfully completing the training, they will implement usual care, which includes screening for geriatric depressive symptoms and providing routine mental health education. The latter comprises basic knowledge of depressive symptoms, prevention methods, standard psychological support care and fundamental psychological problem-solving skills. Following the 8-week intervention, the primary medical staff will offer telephone-based follow-up services for problem-solving related to usual care.
Quality control
To ensure the quality of the intervention, we will implement quality control measures in several key areas. Additionally, an experienced psychologist will oversee the whole project online. She will also provide on-site guidance for the cluster randomised controlled trial in China, contingent on the lifting of travel and gathering restrictions related to the COVID-19 pandemic.
Ensure the quality of training
A team of psychological rehabilitation specialists from tertiary hospitals will provide training courses. Simultaneously, we will administer a strict assessment system. Each trained primary medical staff member can only implement the intervention after completing a theory assessment and a practical skill assessment (independently completing the intervention for two cases). Additionally, we will provide intervention consultation services through booster telephone sessions to resolve intervention-related issues for the trained primary medical staff. Finally, we will assign a project field officer to each TH to guide, assist and supervise the intervention process to ensure the standardisation of intervention delivery. They will record each intervention’s implementation individually to determine the fidelity of the intervention in relation to the primary medical staff’s records.
Improve the motivation to intervention
Certificates will be awarded to primary medical staff who successfully complete the training programme. Meanwhile, after consultation and mutual agreement with the Division of Ageing and Health of the Hunan Provincial Health Planning Commission and the local Health Bureau, the intervention workload will be incorporated into the job performance evaluations of these staff members.
Ensure evaluation standardization
We will assign trained evaluators to collect data face-to-face. All evaluators will undergo standardised training and be supervised by a flow survey specialist. During the baseline assessment, the project team will also appoint an individual to monitor the appraisal process and conduct inter-rater reliability tests for the evaluation.
Variables and measurements
For intervention and control groups, four assessment time points have been established: at the beginning of the study (T-0), immediately post-intervention (T-1), 3 months post-intervention (T-2) and 6 months post-intervention (T-3). Trained evaluators will collect data using standardised questionnaires via face-to-face interactions.
Primary outcomes
Depressive symptoms will be assessed using the GDS, developed by Yesavage et al in 1982.31 The GDS consists of 30 items, each scored as yes (score=1) or no (score=0), with 10 items being reverse-scored. The score range is 0–30, where higher scores indicate more depressive symptoms. The Chinese version of GDS, used among the elderly in rural Chinese communities, has demonstrated good reliability with a Cronbach’s α coefficient of 0.920 and test-retest reliability of 0.729.28
Secondary outcomes
The secondary outcomes include three aspects: psychosocial functioning, quality of life and satisfaction. Psychosocial functioning will be evaluated using the Beck Anxiety Inventory (BAI) and the Social Health Scale for the Elderly (SHSE). Quality of life will be measured by the MOS 36-Item Short Form Health Survey (SF-36), while satisfaction will be assessed by the Satisfaction with Therapy and Therapist Scale (STTS). Details of each scale are provided below:
The 21-item BAI, developed by Beck et al in 1988,32 is a commonly used tool to assess the severity of anxiety. The scale employs a 4-point Likert scale ranging from 0 (not at all) to 3 (severely), with a score range of 0–63. Higher scores indicate increasingly severe symptoms of anxiety. The Chinese version of the BAI demonstrates good reliability, with a Cronbach’s α coefficient of 0.95,33 and has been used among the Chinese rural elderly.20
The 25-item SHSE, developed by Chinese scholar Bao CZ in 2018,34 includes three dimensions and eight subdimensions to assess the social health status of the elderly. Each item is rated on a scale of 1–5 points, resulting in a total score range of 25–125, where higher scores indicate better social health. The SHSE has a Cronbach’s α coefficient of 0.79 and a re-test reliability of 0.77, indicating acceptable reliability.
The SF-36, developed by Ware et al in 1992,35 is widely used to measure general health status. This Likert-type scale consists of eight dimensions, with each dimension’s score being standardised to 0–100 points. Higher scores represent a better quality of life. The Chinese version of SF-36, used among the rural elderly, has a split-half reliability of 0.927, indicating good reliability.
The 12-item STTS, developed by Oei et al in 1999,36 will be used to assess the general satisfaction with interventions and the primary medical staff delivering these interventions. The scale has two dimensions: satisfaction with therapy (seven items) and client evaluation of the therapist (five items). It uses a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with a score range of 12–60. Higher scores indicate better satisfaction. Among patients receiving psychotherapy for depression, the STTS has a Cronbach’s α coefficient of 0.90,36 indicating good reliability.
Covariates
The covariates include age, gender, education, type of residence, economy, frequency of children’s visits, health status, disease, health insurance, activity of daily living, social support and history of psychological counselling or education. Type of residence is categorised as either urban or rural. The condition of economy is represented by the per capita household annual income and is divided into three categories based on 2023 data for urban and rural households in China37: low income (<20 000 RMB), middle income (20 000–50,000 RMB) and high income (>50 000 RMB). The level of social support will be assessed using the Social Support Rating Scale (SSRS), which was developed by the Chinese scholar Shuiyuan Xiao in 1986.38 This 10-item scale evaluates three dimensions: subjective support, objective support and utilisation of support. The SSRS has demonstrated good reliability among the rural elderly in China, as evidenced by a Cronbach’s α coefficient of 0.92.39
Economic evaluation
Economic evaluation includes both cost-utility analysis and cost-effectiveness analysis. The former will be assessed using the Short Form-6D (SF-6D), a common health utility measurement tool developed by Brazier et al in 2002, derived from the SF-36.40 The SF-6D utility score will be calculated using preference weights sourced from a representative sample of the UK general population. For the cost-effectiveness analysis, we will select the number of participants cured of depressive symptoms (GDS <11) as an outcome for comparison. Then, we will calculate all expenses associated with each intervention, including training fees for primary medical staff, equipment fees, the cost of implementing the activity plan, and the costs of health education and counselling services at standardised costs. Finally, we will divide the total costs (the numerator) by the measured outcome (the denominator) to calculate the cost-effectiveness ratio for each intervention and compare their magnitudes.
Intervention Fidelity
The assessment of intervention fidelity will involve a comparative analysis between two versions of intervention records: the intervenor’s version and the project field office’s version. A higher degree of similarity between these records indicates greater fidelity.
Statistical analysis
Given the rate of loss due to intervention and follow-up, an intention-to-treat (ITT) approach will be used to adjust for potential bias. Missing data will be handled using multiple imputation. We will use the mean±SD to describe continuous variables and proportions or percentages to describe categorical variables. Kolmogorov-Smirnov’s test will be used to assess whether the data are normally distributed. When the data are normally distributed, a two-sample t-test will be applied to compare two groups; otherwise, Mann-Whitney’s U-test will be used. A paired-samples t-test will be used for intra-group comparisons. Multivariable analyses will be used to adjust for confounding factors. We will use a generalised linear mixed model (GLMM) to detect the central intervention effect under the random effects at the primary health centre level. If a significant central effect is detected, we will further employ GEEs to estimate the marginal intervention effect across the entire population. Due to the potential increase in type I error rates when GLMM and GEE are used with a small number of clusters, the degrees-of-freedom correction for GLMM using the Kenward-Roger method (implemented via the R package pbkrtest) and the small-sample correction for GEEs (implemented via the R package saws) will be used.41 Sensitivity analyses will involve comparing the results from ITT analysis with those from Per-Protocol analysis. This comparison will help assess the robustness of the study findings against different analytical approaches. The level of statistical significance will be set at 0.05. All statistical analyses will be performed using R 4.0.5.
Harms
According to previous research,20 42 it is unlikely that patients or caregivers will experience any harm from participating in the study. To ensure the safety of participants, it is imperative that qualified clinical psychologists promptly assess individuals when primary medical staff report any sensitive matters, such as the exacerbation of depressive symptoms, the onset of new symptoms, or the progression or intensification of suicidal thoughts, intentions or actions. Appropriate healthcare measures—such as temporarily suspending the participant’s involvement in the trial, modifying or ceasing treatment, or referring the participant for emergency care—should be determined based on the severity of the symptoms and the immediate risk to the individual.
Auditing
The principal investigator will oversee adherence to the protocol and manage the progression of the study. The China Medical Board, serving as the sponsor, will monitor and conduct periodic audits on a selection of studies within its clinical research portfolio. These activities, including monitoring and auditing, will adhere to the procedures established by the sponsor.
Patient and public involvement
Patient and public involvement has been crucial in the development, implementation and monitoring of this trial. The guidelines and specific procedure were reviewed by a panel comprising rural elderly, nurses and country doctors in our previous study.20 In this trial, we will invite the rural elderly to evaluate the MBAT Training Programme provided by their primary medical staff, focusing on its feasibility and acceptability. Prior to this study, we will convene a group of rural elderly, community resident representatives, primary health workers, social education specialists, public health experts and psychologists to form an independent monitoring group. This group will provide supervision and feedback throughout the course of the trial.
Ethics and dissemination
All study procedures will adhere to the Declaration of Helsinki, and approval from the Institutional Review Board of a tertiary hospital has been obtained before the trial begins (No.: 2022-S261). Prior to the commencement of the training programme, researchers will obtain written informed consent from all included primary medical staff. Participants will be informed of their rights and risks and may withdraw at any stage of the trial. Written informed consent will be obtained from each participant prior to the initiation of any intervention. The participant consent form is shown in online supplemental appendix 2. Participants’ personal information will be kept strictly confidential and will not compromise their privacy. Any important protocol modifications (eg, changes to eligibility criteria, outcomes or analyses) will be submitted to the ethics committees as protocol amendments to obtain their approval. To protect personal information, individual patient information will be encrypted. Only the research leaders will have access to the complete merged data set; the evaluators will have access only to part of the dataset. Before export, all identifying information will be stripped out and encrypted, and the statistician will receive the final anonymised data set. A document guaranteeing confidentiality will be signed by all researchers accessing the data. After the completion of this study, eligible rural elderly residents who were not included will be given the opportunity to receive interventions from trained primary medical staff.
Supplemental material
We will publish our results in international peer-reviewed journals and present our findings at both national and international conferences. A final report will be submitted to the funding body, the China Medical Board. The trained primary medical staff will continue providing support to assist rural elderly in managing their depressive symptoms. The MBAT training programme can be adapted for use in rural China and serves as a blueprint. Furthermore, both offline and online training courses will be developed to facilitate the broader implementation of the programme.
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