Evaluation of a Chatbot-Delivered Structured Psychological Intervention for Teenagers With Adolescent Idiopathic Scoliosis

NCT06698952 | Not Yet Recruiting

• 1 other identifier: HSEARS20240919007
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Psychological Health

Outcome Measures

Primary Outcomes (8)

• 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.

  Pre-intervention

• Adherence Rate

  The adherence rate will be monitored through backend data, defined as the percentage of participants who complete the intervention.

  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.

  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.

  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).

  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'.

  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.

  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.

  During the intervention

Secondary Outcomes (4)

• Psychological Distress

  Pre-intervention, immediately after intervention and at 1-month follow-up

• Psychological Well-Being

  Pre-intervention, immediately after intervention and at 1-month follow-up

• Perceived Social Support

  Pre-intervention, immediately after intervention and at 1-month follow-up

• Scoliosis-Related Quality of Life

  Pre-intervention, immediately after intervention and at 1-month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

The chatbot-delivered structured psychological intervention (SPI-Bot)

Other: Intervention Group

Control group

ACTIVE COMPARATOR

Attention control group

Other: control group

Interventions

Intervention Group OTHER

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.

Intervention group

control group OTHER

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.

Control group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Related Publications (1)

• 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.

  PMID: 40659392 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Jiaying Li

CONTACT

852+34002576; jia98ying.li@connect.polyu.hk

Yan Li

CONTACT

852+27666388; yan-nursing.li@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants themselves cannot be blinded to their condition due to the nature of the intervention. However, the statistician conducting data analysis will receive de-identified and de-grouped datasets to ensure blinding during analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 21, 2024
• Study Start: August 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share