Ankylosing Spondylitis (AS)NCT07647965
An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis
A study testing Ecological Momentary Intervention in people with Ankylosing Spondylitis (AS) and Mental Health, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis (AS), Mental Health
- What is being tested?
- Ecological Momentary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
The Rheumatology outpatient department at the First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis: Development, Feasibility Testing, and Preliminary Outcomes Evaluation
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Ankylosing Spondylitis (AS), Mental Health
- Being tested
- Ecological Momentary Intervention, Attention Control Group
- Medical subject headings
- Spondylitis, Ankylosing, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary InterventionOther
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 GroupOther
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 group | Role | What they receive |
|---|---|---|
| Ecological Momentary Intervention | Experimental | The ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program. Receives: Other: Ecological Momentary Intervention |
| Attention Control Group | Active comparator | The attention control group will receive standard counseling and educational brochures about the disease. Receives: Other: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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."
Measured: 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.
Measured: Immediately after intervention and at 4 weeks' follow-up
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after intervention and at 4-weeks' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647965
- Sponsor's protocol ID
- HSEARS20260310001
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis: Development, Feasibility Testing, and Preliminary Outcomes Evaluation
- ClinicalTrials.gov ID
- NCT07647965
- Acronym / sponsor ID
- HSEARS20260310001
- Conditions
- Ankylosing Spondylitis (AS), Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ecological Momentary Intervention | Experimental | Other: Ecological Momentary InterventionThe ecological momentary intervention delivered through the "Spinal Heart Journey" WeChat mini-program. |
| Attention Control Group | Active comparator | Other: Attention Control GroupThe attention control group will receive standard counseling and educational brochures about the disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary InterventionParticipants 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. | Other | Ecological Momentary Intervention |
| Attention Control GroupParticipants 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. | Other | Attention Control Group |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Depression and anxiety
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Stress
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Pain level
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Insomnia
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Illness perception
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Coping strategies
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
General quality of life
Time frame: Baseline, immediately after intervention and at 4-weeks' follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Intervention in people with Ankylosing Spondylitis (AS) and Mental Health, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.