About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Intervention Group
Other interventionThe 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 group
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Adherence Rate
The adherence rate will be monitored through backend data, defined as the percentage of participants who complete the intervention.
Attrition Rate
The attrition rate is the percentage of participants lost to follow-up, and the reasons for attrition will also be recorded.
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.
Secondary outcomes
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.
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.
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.
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).
Locations
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