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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.
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.
This study will provide initial evidence on whether a tailored ecological momentary intervention is feasible, acceptable, and potentially beneficial for improving mental health in individuals with ankylosing spondylitis and will inform the design of a future larger trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecological Momentary Intervention | Experimental | The ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program. |
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| Attention Control Group | Active Comparator | The attention control group will receive standard counseling and educational brochures about the disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological Momentary Intervention | Other | Participants allocated to the intervention group will complete six daily 20-minute video-based CBT sessions over the first week, with a Q&A session held on the final day of this week. From Week 2 to Week 5, they will complete daily ecological momentary assessments (3 items, <1 minute per assessment) at random time points between 9:00 AM and 9:00 PM. When scores for pain, anxiety, or depression exceed preset thresholds, tailored intervention modules will be activated, each requiring 10-15 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | 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 | Baseline |
| Retention rate | 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 | Immediately after intervention and at 4 weeks' follow-up |
| Dropout rate | The dropout rate will be calculated as the percentage of participants who voluntarily withdrew from the study out of the initial recruitment number | Immediately after intervention and at 4 weeks' follow-up |
| Adherence rate | 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. | From baseline to immediately after intervention |
| Usability | 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." | Immediately after intervention |
| User experience | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression and anxiety | The depression and anxiety subscales of the Depression Anxiety Stress Scale-21 items will be employed to assess participants' levels of depression and anxiety. Each subscale comprises 7 items and evaluates negative emotional experiences and corresponding physiological responses over the past week. Higher scores indicate greater severity of negative affectivity, with responses rated on a 4-point Likert scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rheumatology outpatient department at the First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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Eligible participants will be randomized to either the intervention or control groups, with the former receiving the ecological momentary intervention and the latter receiving standard counseling and educational brochures about the disease.
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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.
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| Attention Control Group | Other | Participants in the control group will receive standard counseling and educational brochures about the disease. They will be asked to read the educational materials at their own pace during the first 5 weeks, with no additional structured assessments and intervention modules required. |
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| Immediately after intervention and at 4 weeks' follow-up |
| Baseline, immediately after intervention and at 4-weeks' follow-up |
| Stress | The stress subscale of the Depression Anxiety Stress Scale-21 items will be utilized to measure stress as a distinct construct. This subscale also consists of 7 items, which assess negative emotional experiences related to stressors encountered in the previous week. Similar to the depression and anxiety subscales, higher scores on the stress subscale reflect greater levels of stress experienced by participants. | Baseline, immediately after intervention and at 4-weeks' follow-up |
| Pain level | The Visual Analogue Scale, a unidimensional tool for measuring pain intensity, will be utilized to assess patients' levels of pain. It has been widely applied across various adult populations for pain intensity evaluation. The scale consists of a 10-centimeter line on which patients mark their perceived pain intensity, with "no pain" at one end and "imagined worst pain" at the other. The distance from the "no pain" point to the participant's mark is then measured to determine the final score, which ranges from 0 to 10, with higher scores indicating greater pain intensity. | Baseline, immediately after intervention and at 4-weeks' follow-up |
| Insomnia | The Insomnia Severity Index, a patient-reported 7-item questionnaire, will be used to assess insomnia symptoms and their impact on daytime functioning. Each item is rated on a scale from 0 to 4, where 0 indicates no problem and 4 indicates a very severe problem, resulting in a total score that ranges from 0 to 28. Scores can be interpreted as follows: absence of insomnia (0-7), subthreshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). | Baseline, immediately after intervention and at 4-weeks' follow-up |
| Illness perception | The Brief Illness Perception Questionnaire will be utilized to assess cognitive and emotional representations of illness. The scale consists of eight items graded on a linear 0-10 response scale, with higher scores indicating a more threatening perception of the illness. Each item assesses a specific dimension of illness perception, including consequences, timeline, personal control, treatment control, illness identity, concern, coherence, and emotional representation. The ninth item, which is causal and involves an open-ended response, will be excluded from the analysis. | Baseline, immediately after intervention and at 4-weeks' follow-up |
| Coping strategies | The Trait Coping Style Questionnaire will be employed to assess participants' coping strategies. This 20-item questionnaire includes two dimensions, positive and negative coping, scored on a five-point Likert scale. Higher scores in each dimension (ranging from 10 to 50) reflect a greater tendency to employ that specific coping style. The scale has demonstrated adequate reliability and validity. | Baseline, immediately after intervention and at 4-weeks' follow-up |
| General quality of life | The Short-Form 12-Item Version 2 will be employed to assess eight distinct health domains, evaluating both physical and mental health. Physical health-related domains include general health, physical functioning, role physical, and body pain. The mental health-related scales encompass vitality, social functioning, role, emotional health, and mental health. Scores on the Short-Form 12 Item Version 2 range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Baseline, immediately after intervention and at 4-weeks' follow-up |
| School of Nursing, The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |