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NCT07647965Active, not recruiting

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

An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis: Development, Feasibility Testing, and Preliminary Outcomes Evaluation

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
10 Jun 2026
Start date
1 Apr 2026
Primary completion date
31 Mar 2027
Lead sponsor
The Hong Kong Polytechnic University
NCT number
NCT07647965

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 1 Apr 2026 to the primary completion date, 31 Mar 2027
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Are currently participating in other psychosocial interventions

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Rheumatology outpatient department at the First Affiliated Hospital of Guangzhou University of Chinese Medicine
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
School of Nursing, The Hong Kong Polytechnic University
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.