An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis: Development, Feasibility Testing, and Preliminary Outcomes Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Ankylosing spondylitis is a chronic inflammatory rheumatic disease associated with pain, stiffness, reduced mobility, and impaired quality of life. In addition to physical symptoms, individuals with ankylosing spondylitis frequently experience depression, anxiety, stress, and sleep problems. However, existing mental health support is limited and often relies on static assessments and scheduled interventions, which may not respond to patients' fluctuating daily symptoms.
This study aims to develop and pilot test a WeChat-based ecological momentary intervention to improve mental health in individuals with ankylosing spondylitis in China. The study is a prospective, parallel-group, assessor-blinded pilot randomized controlled trial. A total of 36 adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be randomized 1:1 to either an intervention group or a control group.
The intervention group will first receive six brief video-based sessions on cognitive behavioral therapy-related skills during week 1. During weeks 2 to 5, participants will use a WeChat mini-program to complete daily ecological momentary assessments of pain, depression, and anxiety. Symptom-triggered intervention modules will then provide brief, tailored strategies such as cognitive restructuring, behavioral activation, relaxation exercises, self-compassion practice, and SMART goal setting. The control group will receive standard counseling and educational materials.
The primary purpose of this pilot study is to assess feasibility and acceptability, including recruitment, adherence, attrition, engagement, usability, satisfaction, and adverse events. Preliminary effects on depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life will also be explored at baseline, post-intervention, and 4-week follow-up.
详细描述
Ankylosing spondylitis is a chronic inflammatory disease that mainly affects the spine and sacroiliac joints and may result in persistent pain, stiffness, limited mobility, and functional impairment. Individuals with ankylosing spondylitis are also at increased risk of mental health problems, especially depression and anxiety. These psychological difficulties often fluctuate with pain, disease activity, and daily stress, but few interventions have been specifically designed to address these changing needs in real time.
Ecological momentary intervention is a mobile health approach that delivers timely, personalized support in daily life based on real-time symptom reports. Although ecological momentary intervention has shown benefits in mental health and some rheumatic conditions, it has not yet been specifically developed for individuals with ankylosing spondylitis.
This study aims to assess the feasibility, acceptability, and preliminary efficacy of a WeChat-based ecological momentary intervention for individuals with ankylosing spondylitis in China. The study is designed as a prospective, parallel-group, assessor-blinded pilot randomized controlled trial with a 1:1 allocation ratio. Thirty-six eligible adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be recruited from the rheumatology outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Participants in the intervention group will receive six daily video-based cognitive behavioral therapy-related sessions in week 1, followed by 4 weeks of ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program. During the ecological momentary intervention phase, participants will complete one brief daily ecological momentary assessment assessing pain, depressive mood, and anxiety. If symptom scores reach a predefined threshold, the corresponding brief intervention module will be activated. Modules include strategies such as thought recording, cognitive restructuring, behavioral activation, relaxation training, self-compassion exercises, and SMART goal setting. Participants in the control group will receive standard counseling and disease-related educational brochures.
The primary focus of this pilot trial is feasibility and acceptability, including recruitment, adherence, attrition, utilization, engagement, usability, satisfaction, and adverse events. Preliminary outcomes include depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life. Outcomes will be assessed at baseline, immediately post-intervention, and 4 weeks after the intervention. In addition, post-intervention qualitative interviews will be conducted with selected participants to explore user experiences and inform refinement of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants themselves cannot be blinded to their condition due to the nature of the intervention. However, the statistician conducting data analysis will receive de-identified and de-grouped datasets to ensure blinding during analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ankylosing spondylitis
- •Aged 18 years or above
- •Exhibiting mild to moderate levels of depression (scoring between 10 and 20 on the depression subscale of the Depression Anxiety Stress Scale-21 items) or anxiety (scoring between 8 and 14 on the anxiety subscale of the Depression Anxiety Stress Scale-21 items)
- •Maintained stable drug treatment in the 3 months before recruitment
- •Able to perform basic daily activities (such as walking, sitting, etc.)
- •Able to use a smartphone to engage in the ecological momentary intervention ● Proficient in Cantonese and/or Mandarin Chinese and have the necessary comprehension abilities to understand and be willing to give informed consent
排除标准
- •Have a diagnosed mental illness or a history of mental illness
- •Have other severe chronic diseases (e.g., cardiovascular disease, cancer) that may affect study outcomes or intervention effects
- •Are currently participating in other psychosocial interventions
结局指标
主要结局
Recruitment rate
时间窗: Baseline
The recruitment rate will be calculated as the percentage of eligible participants who enroll in the study out of the total number of eligible participants
Retention rate
时间窗: Immediately after intervention and at 4 weeks' follow-up
The retention rate will be calculated as the percentage of participants who completed the entire research process (including the follow-up) out of the initial recruitment
Dropout rate
时间窗: Immediately after intervention and at 4 weeks' follow-up
The dropout rate will be calculated as the percentage of participants who voluntarily withdrew from the study out of the initial recruitment number
Adherence rate
时间窗: From baseline to immediately after intervention
Adherence rate will be measured using two indicators. First, for each momentary assessment, we will determine whether it has been answered (1 for answered, 0 for not answered). Second, adherence to the intervention will be assessed using the number of completed ecological momentary intervention interactive techniques.
Usability
时间窗: Immediately after intervention
The usability of the intervention will be evaluated using the System Usability Scale, a tool capable of assessing the usability of diverse technology-based applications. This scale comprises 10 questions rated on a five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree."
User experience
时间窗: Immediately after intervention and at 4 weeks' follow-up
To assess program satisfaction, the Acceptability of the Intervention measure will be utilized. This four-item instrument utilizes a 5-point Likert scale (1=completely disagree; 5=completely agree). Higher scores indicate a greater acceptability of the intervention. Subsequently, ten participants will be selected for individual semi-structured interviews to gather insights regarding their experiences and perceptions of the ecological momentary intervention, the challenges encountered during the four weeks, and suggested improvements.
次要结局
- Depression and anxiety(Baseline, immediately after intervention and at 4-weeks' follow-up)
- Stress(Baseline, immediately after intervention and at 4-weeks' follow-up)
- Pain level(Baseline, immediately after intervention and at 4-weeks' follow-up)
- Insomnia(Baseline, immediately after intervention and at 4-weeks' follow-up)
- Illness perception(Baseline, immediately after intervention and at 4-weeks' follow-up)
- Coping strategies(Baseline, immediately after intervention and at 4-weeks' follow-up)
- General quality of life(Baseline, immediately after intervention and at 4-weeks' follow-up)