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

NCT07647965 | Active Not Recruiting

• 1 other identifier: HSEARS20260310001
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Mental Health; Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (6)

• 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.

  Immediately after intervention and at 4 weeks' follow-up

Secondary Outcomes (7)

• 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

Study Arms (2)

The ecological momentary intervention

EXPERIMENTAL

The ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program.

Other: Intervention Group

Control group

ACTIVE COMPARATOR

Attention control group

Other: Control group

Interventions

Intervention Group 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.

The ecological momentary intervention

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (1) Clinical diagnosis of ankylosing spondylitis; (2) aged 18 years or above; (3) 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) \[51\]; (4) maintained stable drug treatment in the 3 months before recruitment; (5) able to perform basic daily activities (such as walking, sitting, etc.); (6) able to use a smartphone to engage in the ecological momentary intervention; (7) proficient in Cantonese and/or Mandarin Chinese and have the necessary comprehension abilities to understand and be willing to give informed consent.

You may not qualify if:

• (1) have a diagnosed mental illness or a history of mental illness; (2) have other severe chronic diseases (e.g., cardiovascular disease, cancer) that may affect study outcomes or intervention effects; (3) are currently participating in other psychosocial interventions.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Rheumatology outpatient department at the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, China

Location

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)