An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Ecological Momentary Intervention: 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.

Attention Control Group: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Recruitment rate — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (2)

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