Adolescent Idiopathic Scoliosis (AIS)NCT06698952
Evaluation of a Chatbot-Delivered Structured Psychological Intervention for Teenagers With Adolescent Idiopathic Scoliosis
A study testing Intervention Group in people with Adolescent Idiopathic Scoliosis (AIS) and Psychological Health, run by The Hong Kong Polytechnic University.
Trial summary
Adolescent idiopathic scoliosis is the most common spinal deformity in children and can significantly impact the psychological health of affected teenagers. Despite this, there are few effective psychological treatments available for this population. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Psychological Health
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 1 Feb 2026
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a Cobb angle (a standard method for measuring spinal curvature) greater than 10 degrees;
- Exhibit mild to moderate levels of depression, anxiety, or stress (scoring between 7-13 on the depression subscale, 6-12 on the anxiety subscale, or 12-16 on the stress subscale of the Depression Anxiety Stress Scales for Youth);
- Be aged between 10 and 18;
- Be proficient in Cantonese and traditional Chinese character reading;
- Own a smartphone and being adept at using it.
Who cannot join
- Have a diagnosis of psychiatric disorders or serious physical diseases;
- Are currently undergoing other psychological interventions;
- Are on a surgery waiting list or in the perioperative period (from seven days before to seven days after surgery);
- Are unable to provide consent for study participation;
- Exhibit self-harm or suicidal tendencies (scoring > 0 on the ninth item of the Patient Health Questionnaire-9: "Thoughts that you would be better off dead, or of hurting yourself in some way").
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Chatbot-Delivered Structured Psychological Intervention (SPI-Bot) for Teenagers With Adolescent Idiopathic Scoliosis: A Pilot Randomized Controlled Trial
Adolescent idiopathic scoliosis is the most common spinal deformity in children and can significantly impact the psychological health of affected teenagers. Despite this, there are few effective psychological treatments available for this population. Cognitive and behavioral strategies show promise in addressing the challenges associated with the condition and its treatment. Chatbots could serve as an accessible and effective tool to support the psychological health of these teenagers.
Using the Centre for eHealth Research and Disease Management Roadmap as a guide, a chatbot-based structured psychological intervention has been developed. This intervention incorporates cognitive and behavioral strategies and aims to improve the psychological health of teenagers with adolescent idiopathic scoliosis. The current phase involves implementing the intervention and conducting a pilot test to assess its feasibility, acceptability, and preliminary effectiveness.
The study will employ a pilot randomized controlled trial design, nested with qualitative interviews. Participants will be recruited from community health organizations in Hong Kong and will be randomly assigned to either a control group or an intervention group using block randomization. The intervention group will engage with the chatbot-based structured psychological intervention for eight consecutive weeks. The control group will interact with a different generative chatbot, participating in casual conversations at a similar frequency. Quantitative assessments will be conducted at three points: baseline, immediately after the intervention, and one month after the intervention. Additionally, qualitative interviews will be held with selected participants from the intervention group at post-intervention to explore their experiences and perceptions of the intervention process.
Read the detailed description
Introduction: Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis, affecting 0.9% to 12.0% of the global population. In Hong Kong, AIS affects about 4.7% of adolescents, with an annual increase of 0.61%. AIS may cause physical deformity and back pain, and severe cases may lead to long-term health issues like impaired lung function and functional limitations in adulthood. Adolescence is crucial for psychological development, with many mental disorders beginning during this period. Teenagers with AIS face additional challenges, such as body image issues, restricted physical function, and pain, increasing their risk for psychological problems. They often report stress, anxiety, and depression, which can lead to more severe mental health issues if untreated. Social isolation and avoidance can worsen these psychological challenges.
Despite the importance of psychological health, it is often overlooked in AIS treatment. While the new medical model emphasizes integrating psychological care with physical treatment, few clinical trials focus on AIS, mainly addressing perioperative anxiety with limited psychological benefits. Cognitive behavioral therapy (CBT) has proven effective for children with long-term conditions and holds promise for AIS. Cognitive techniques can help modify biased thoughts, while behavioral approaches like relaxation training and activity scheduling can alleviate distress and encourage positive behaviors. However, research on CBT for AIS is limited and methodologically flawed, leaving its effectiveness unproven.
Access to psychological interventions like CBT is challenging due to resource shortages and personal barriers such as stigma and cost. Chatbots offer a potential solution by providing accessible, anonymous, and flexible interventions. They are well-received and engaging for youth but have not yet been explored for the AIS population.
Objectives: To address the gap in psychological health among the AIS population, the research team has developed a chatbot-delivered structured psychological intervention (SPI-Bot) that incorporates cognitive and behavioral strategies. The objectives of this pilot randomized controlled trial (RCT) are as follows: 1) The SPI-Bot will be feasible and acceptable, as measured by recruitment, adherence, and attrition rates, utilization and engagement, working alliance, usability, user experience, and adverse events record (primary outcome). 2) The SPI-Bot (intervention) group will be more significantly effective in enhancing psychological distress, psychological well-being, pain, perceived body image, physical function, perceived social support, and quality of life compared to the control group, with the potential for this effect to persist for one-month post-intervention.
Design: The trial is an open-label, double-arm, and single-center pilot RCT with a 1:1 allocation ratio and includes a follow-up evaluation. The intervention group will use the SPI-Bot for eight consecutive weeks. Meanwhile, the control group will interact with a different generative chatbot, engaging in casual conversations at a similar dosage to ensure balanced attention and interaction effects. This clinical trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot trials.
Participants and recruitment: Participants will be recruited from community health organisations in Hong Kong. As part of the registration, the participants will have to fill out an initial screening questionnaire that assesses inclusion criteria.
Assessments will take place starting with psychological symptoms screening in hospital outpatient clinic followed by three assessment points: baseline (T0), eight weeks after randomization (T1, post-intervention), and twelve weeks after randomization (T2, follow-up assessment).
- Being tested
- Intervention Group, control group
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
The intervention group will engage with SPI-Bot, a conversational agent designed to deliver cognitive and behavioral strategies for managing psychological symptoms through fully automated interactions. SPI-Bot operates on a template-based platform with predefined dialogue options, utilizing natural language processing technology. The intervention spans eight weeks and includes key components such as psychoeducation, cognitive restructuring, relaxation training, activity scheduling, problem-solving skills training, and social skills training. Participants will complete one session per week over the eight-week period. Participants will receive weekly contact from the research team to report AIS symptoms, receive homework reminders, and address any intervention-related questions.
control groupOther
Participants in the control group will interact with a different generative chatbot, engaging in casual conversations at a similar dosage to ensure balanced attention and interaction effects.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The chatbot-delivered structured psychological intervention (SPI-Bot) Receives: Other: Intervention Group |
| Control group | Active comparator | Attention control group Receives: Other: 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, along with documenting the reasons for declining participation.
Measured: Pre-intervention
Adherence Rate
The adherence rate will be monitored through backend data, defined as the percentage of participants who complete the intervention.
Measured: Immediately after intervention
Attrition Rate
The attrition rate is the percentage of participants lost to follow-up, and the reasons for attrition will also be recorded.
Measured: Immediately after intervention and at 1-month follow-up
Engagement
De-identified aggregated chatbot usage data will be obtained from the developers to evaluate engagement. Metrics collected will include aggregated descriptive summaries: total check-ins, days in the chatbot, and messages sent during the eight-week intervention period.
Measured: Immediately after intervention
Working Alliance
The Working Alliance Inventory-Short Revised will be used. It measures the three aspects of the therapeutic alliance: agreement on the tasks of therapy; agreement on the goals of therapy; and development of an affective bond between patient and therapist. The scores of all 12 items range from 1 (never) to 5 (always).
Measured: Immediately after intervention
Usability
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 to be rated on a five-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Measured: Immediately after intervention
User Experience
Participants from the intervention group will be chosen for individual semi-structured interviews based on their adherence status (completed vs. incomplete). Participants will be informed about the interview's objectives and process, and will be encouraged to provide feedback on the experience and perception of the SPI-Bot, the difficulty of using it, and the suggested improvements.
Measured: Immediately after intervention
Adverse events
Adverse events related to the intervention, such as dizziness, fatigue, or headache from smartphone use, will be monitored and recorded through participant self-reports.
Measured: During the intervention
Secondary outcomes (4)
Psychological Distress
This will be measured by the Depression Anxiety Stress Scales for Youth. Participants will be asked to rate on four-point Likert scale from 0 (never) to 3 (almost always). Subscale scores can be calculated by adding the scores for the individual items, with higher scores indicating greater levels of distress.
Measured: Pre-intervention, immediately after intervention and at 1-month follow-up
Psychological Well-Being
Participants' well-being will be assessed using the WHO-5 Well-Being Index, which is a brief five-item self-reported measure. Participants will be asked to report their experiences in the past two weeks on a six-point Likert scale, ranging from 0 (at no time) to 5 (all of the time). The raw well-being score theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). The WHO-5 has shown both clinical and psychometric validity and has been previously integrated in psychological health-related mobile applications.
Measured: Pre-intervention, immediately after intervention and at 1-month follow-up
Perceived Social Support
The study will use the Multidimensional Scale of Perceived Social Support, comprising three domains: family support, friend support, and other support, totaling 12 items. This seven-point Likert scale assesses perceived social support, with a score range of 12 to 36 indicating low support, 37 to 60 indicating moderate support, and 61 to 84 indicating high support. The Chinese version has demonstrated strong psychometric properties when used with adolescents.
Measured: Pre-intervention, immediately after intervention and at 1-month follow-up
Scoliosis-Related Quality of Life
The refined Scoliosis Research Society 22-item questionnaire will be employed to measure the quality of life. It consists of five domains: pain, self-image/appearance, function/activity, mental health, and management satisfaction. Each item is scored from 1 (worst) to 5 (best).
Measured: Pre-intervention, immediately after intervention and at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start15 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)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 randomised to either the intervention or control groups with the former receiving the chatbot-delivered structured psychological intervention and the latter receiving a different generative chatbot to have casual conversations at a similar frequency.
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT06698952
- Sponsor's protocol ID
- HSEARS20240919007
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Zhang T, Cheung JPY, Meng N, Wu Z, Ma DCF, Chan EA, Yu L, Cao Y, Li Y. Chatbot-delivered structured psychological intervention (SPI-Bot) for teenagers with adolescent idiopathic scoliosis in Hong Kong: protocol for a pilot randomised controlled trial. BMJ Open. 2025 Jul 13;15(7):e098734. doi: 10.1136/bmjopen-2025-098734.
PubMed 40659392
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Chatbot-Delivered Structured Psychological Intervention (SPI-Bot) for Teenagers With Adolescent Idiopathic Scoliosis: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06698952
- Acronym / sponsor ID
- HSEARS20240919007
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Nov 2024 (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.
Adolescent idiopathic scoliosis is the most common spinal deformity in children and can significantly impact the psychological health of affected teenagers. Despite this, there are few effective psychological treatments available for this population. Cognitive and behavioral strategies show promise in addressing the challenges associated with the condition and its treatment. Chatbots could serve as an accessible and effective tool to support the psychological health of these teenagers.
Using the Centre for eHealth Research and Disease Management Roadmap as a guide, a chatbot-based structured psychological intervention has been developed. This intervention incorporates cognitive and behavioral strategies and aims to improve the psychological health of teenagers with adolescent idiopathic scoliosis. The current phase involves implementing the intervention and conducting a pilot test to assess its feasibility, acceptability, and preliminary effectiveness.
The study will employ a pilot randomized controlled trial design, nested with qualitative interviews. Participants will be recruited from community health organizations in Hong Kong and will be randomly assigned to either a control group or an intervention group using block randomization. The intervention group will engage with the chatbot-based structured psychological intervention for eight consecutive weeks. The control group will interact with a different generative chatbot, participating in casual conversations at a similar frequency. Quantitative assessments will be conducted at three points: baseline, immediately after the intervention, and one month after the intervention. Additionally, qualitative interviews will be held with selected participants from the intervention group at post-intervention to explore their experiences and perceptions of the intervention process.
Detailed description
Introduction: Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis, affecting 0.9% to 12.0% of the global population. In Hong Kong, AIS affects about 4.7% of adolescents, with an annual increase of 0.61%. AIS may cause physical deformity and back pain, and severe cases may lead to long-term health issues like impaired lung function and functional limitations in adulthood. Adolescence is crucial for psychological development, with many mental disorders beginning during this period. Teenagers with AIS face additional challenges, such as body image issues, restricted physical function, and pain, increasing their risk for psychological problems. They often report stress, anxiety, and depression, which can lead to more severe mental health issues if untreated. Social isolation and avoidance can worsen these psychological challenges.
Despite the importance of psychological health, it is often overlooked in AIS treatment. While the new medical model emphasizes integrating psychological care with physical treatment, few clinical trials focus on AIS, mainly addressing perioperative anxiety with limited psychological benefits. Cognitive behavioral therapy (CBT) has proven effective for children with long-term conditions and holds promise for AIS. Cognitive techniques can help modify biased thoughts, while behavioral approaches like relaxation training and activity scheduling can alleviate distress and encourage positive behaviors. However, research on CBT for AIS is limited and methodologically flawed, leaving its effectiveness unproven.
Access to psychological interventions like CBT is challenging due to resource shortages and personal barriers such as stigma and cost. Chatbots offer a potential solution by providing accessible, anonymous, and flexible interventions. They are well-received and engaging for youth but have not yet been explored for the AIS population.
Objectives: To address the gap in psychological health among the AIS population, the research team has developed a chatbot-delivered structured psychological intervention (SPI-Bot) that incorporates cognitive and behavioral strategies. The objectives of this pilot randomized controlled trial (RCT) are as follows: 1) The SPI-Bot will be feasible and acceptable, as measured by recruitment, adherence, and attrition rates, utilization and engagement, working alliance, usability, user experience, and adverse events record (primary outcome). 2) The SPI-Bot (intervention) group will be more significantly effective in enhancing psychological distress, psychological well-being, pain, perceived body image, physical function, perceived social support, and quality of life compared to the control group, with the potential for this effect to persist for one-month post-intervention.
Design: The trial is an open-label, double-arm, and single-center pilot RCT with a 1:1 allocation ratio and includes a follow-up evaluation. The intervention group will use the SPI-Bot for eight consecutive weeks. Meanwhile, the control group will interact with a different generative chatbot, engaging in casual conversations at a similar dosage to ensure balanced attention and interaction effects. This clinical trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot trials.
Participants and recruitment: Participants will be recruited from community health organisations in Hong Kong. As part of the registration, the participants will have to fill out an initial screening questionnaire that assesses inclusion criteria.
Assessments will take place starting with psychological symptoms screening in hospital outpatient clinic followed by three assessment points: baseline (T0), eight weeks after randomization (T1, post-intervention), and twelve weeks after randomization (T2, follow-up assessment).
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 randomised to either the intervention or control groups with the former receiving the chatbot-delivered structured psychological intervention and the latter receiving a different generative chatbot to have casual conversations at a similar frequency.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention GroupThe chatbot-delivered structured psychological intervention (SPI-Bot) |
| Control group | Active comparator | Other: control groupAttention control group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Have a Cobb angle (a standard method for measuring spinal curvature) greater than 10 degrees;
- Exhibit mild to moderate levels of depression, anxiety, or stress (scoring between 7-13 on the depression subscale, 6-12 on the anxiety subscale, or 12-16 on the stress subscale of the Depression Anxiety Stress Scales for Youth);
- Be aged between 10 and 18;
- Be proficient in Cantonese and traditional Chinese character reading;
- Own a smartphone and being adept at using it.
Key exclusion criteria (5 listed)
- Have a diagnosis of psychiatric disorders or serious physical diseases;
- Are currently undergoing other psychological interventions;
- Are on a surgery waiting list or in the perioperative period (from seven days before to seven days after surgery);
- Are unable to provide consent for study participation;
- Exhibit self-harm or suicidal tendencies (scoring > 0 on the ninth item of the Patient Health Questionnaire-9: "Thoughts that you would be better off dead, or of hurting yourself in some way").
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 |
|---|---|---|
| Intervention GroupThe intervention group will engage with SPI-Bot, a conversational agent designed to deliver cognitive and behavioral strategies for managing psychological symptoms through fully automated interactions. SPI-Bot operates on a template-based platform with predefined dialogue options, utilizing natural language processing technology. The intervention spans eight weeks and includes key components such as psychoeducation, cognitive restructuring, relaxation training, activity scheduling, problem-solving skills training, and social skills training. Participants will complete one session per week over the eight-week period. Participants will receive weekly contact from the research team to report AIS symptoms, receive homework reminders, and address any intervention-related questions. | Other | Intervention group |
| control groupParticipants in the control group will interact with a different generative chatbot, engaging in casual conversations at a similar dosage to ensure balanced attention and interaction effects. | Other | Control group |
Primary outcome
Recruitment Rate
Time frame: Pre-intervention
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, along with documenting the reasons for declining participation.
Adherence Rate
Time frame: Immediately after intervention
The adherence rate will be monitored through backend data, defined as the percentage of participants who complete the intervention.
Attrition Rate
Time frame: Immediately after intervention and at 1-month follow-up
The attrition rate is the percentage of participants lost to follow-up, and the reasons for attrition will also be recorded.
Engagement
Time frame: Immediately after intervention
De-identified aggregated chatbot usage data will be obtained from the developers to evaluate engagement. Metrics collected will include aggregated descriptive summaries: total check-ins, days in the chatbot, and messages sent during the eight-week intervention period.
Working Alliance
Time frame: Immediately after intervention
The Working Alliance Inventory-Short Revised will be used. It measures the three aspects of the therapeutic alliance: agreement on the tasks of therapy; agreement on the goals of therapy; and development of an affective bond between patient and therapist. The scores of all 12 items range from 1 (never) to 5 (always).
Usability
Time frame: Immediately after intervention
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 to be rated on a five-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
User Experience
Time frame: Immediately after intervention
Participants from the intervention group will be chosen for individual semi-structured interviews based on their adherence status (completed vs. incomplete). Participants will be informed about the interview's objectives and process, and will be encouraged to provide feedback on the experience and perception of the SPI-Bot, the difficulty of using it, and the suggested improvements.
Adverse events
Time frame: During the intervention
Adverse events related to the intervention, such as dizziness, fatigue, or headache from smartphone use, will be monitored and recorded through participant self-reports.
4 secondary outcomes
Psychological Distress
Time frame: Pre-intervention, immediately after intervention and at 1-month follow-up
Psychological Well-Being
Time frame: Pre-intervention, immediately after intervention and at 1-month follow-up
Perceived Social Support
Time frame: Pre-intervention, immediately after intervention and at 1-month follow-up
Scoliosis-Related Quality of Life
Time frame: Pre-intervention, immediately after intervention and at 1-month 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 10 Jun 2025.
- Derived from this study: PubMed 40659392Li J, Zhang T, Cheung JPY, Meng N, Wu Z, Ma DCF, Chan EA, Yu L, Cao Y, Li Y. Chatbot-delivered structured psychological intervention (SPI-Bot) for teenagers with adolescent idiopathic scoliosis in Hong Kong: protocol for a pilot randomised controlled trial. BMJ Open. 2025 Jul 13;15(7):e098734. doi: 10.1136/bmjopen-2025-098734.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Adolescent Idiopathic Scoliosis (AIS) and Psychological Health, run by The Hong Kong Polytechnic University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jiaying Li (852+34002576, jia98ying.li@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Pre-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698952, which also lists 1 linked publication.
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 10 Jun 2025.