Clinical trial NCT06698952: Evaluation of a Chatbot-Delivered Structured Psychological Intervention for Teenagers With Adolescent Idiopathic Scoliosis
Official title: Evaluation of a Chatbot-Delivered Structured Psychological Intervention (SPI-Bot) for Teenagers With Adolescent Idiopathic Scoliosis: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis (AIS)
Psychological Health
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 52
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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").

Primary outcomes:
measure: Recruitment Rate
timeFrame: Pre-intervention
measure: Adherence Rate
timeFrame: Immediately after intervention
measure: Attrition Rate
timeFrame: Immediately after intervention and at 1-month follow-up
measure: Engagement
timeFrame: Immediately after intervention
measure: Working Alliance
timeFrame: Immediately after intervention
measure: Usability
timeFrame: Immediately after intervention
measure: User Experience
timeFrame: Immediately after intervention
measure: Adverse events
timeFrame: During the intervention
Secondary outcomes:
measure: Psychological Distress
timeFrame: Pre-intervention, immediately after intervention and at 1-month follow-up
measure: Psychological Well-Being
timeFrame: Pre-intervention, immediately after intervention and at 1-month follow-up
measure: Perceived Social Support
timeFrame: Pre-intervention, immediately after intervention and at 1-month follow-up
measure: Scoliosis-Related Quality of Life
timeFrame: Pre-intervention, immediately after intervention and at 1-month follow-up
Other outcomes:
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