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).
