Assessing the Clinical and Cost Effectiveness of Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 6
- 主要终点
- Change in the depression scores (PHQ-9) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
研究概览
简要总结
Cognitive-behavioural therapy (CBT) has a robust evidence base for treating anxiety disorders and depression, including transdiagnostic CBT. Internet-based CBT (iCBT) offers a new approach to delivering these therapies. iCBT is a digital adaptation of traditional CBT that leverages digital platforms to deliver similar therapeutic interventions. iCBT encompasses structured programmes that provide users with tools and techniques to manage mental health issues such as depression and anxiety. The digital format ensures timely access to CBT and typically includes interactive modules, videos, self-assessment tools, and virtual therapist support. This study aims to evaluate the effectiveness of iCBT in reducing symptoms of anxiety and depression, as well as its cost-effectiveness and acceptability in local context.
The main questions it aims to answer are:
- Do participants receiving iCBT show a reduction in symptoms of anxiety and/or depression, and does the effectiveness of iCBT vary based on individual user characteristics?
- What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans?
- Is iCBT more cost-effective as compared to usual care?
Researchers will compare guided iCBT to usual care (traditional CBT) to assess iCBT's clinical effectiveness, cost-effectiveness, and acceptability in Singapore's primary and community healthcare settings.
Participants in the intervention group will:
- Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques
- Counsellors will schedule 3 regular check-ins
- Questionnaires will be administered at 5 timepoints
- Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT
Participants in the control group will:
- Continue usual care
- Questionnaires will be administered at 5 timepoints
A parallel qualitative study involving service providers is required to contextualise trial findings, identify implementation barriers and enablers and inform national scale-up and policy decisions. It aims to explore service providers' experiences, perceptions and contextual factors influencing the implementation of iCBT within routine primary-care and community mental-health services participating in this trial.
详细描述
This multi-agency collaboration study involves partners from MOH Office for Healthcare Transformation (MOHT), Agency of Integrated Care (AIC), and selected Community Intervention Team (COMIT) providers. Participants will be recruited from COMIT providers, which may include patients referred from the primary healthcare sector. Study visits (e.g. iCBT programme, questionnaires, counsellor check-ins) will be conducted online and/or at COMIT sites, where COMIT are the service providers with AIC.
Research procedures were developed with the MOHT co-investigators to design the study protocol, recruitment and operational workflows, and risk management protocols. MOHT leads the development of the iCBT programme, including but not limited to the mobile application interface, intervention materials, interactive exercises, and homework assignments, which would be tested before rolling out to the research participants. Study evaluations (e.g. data analysis, literature reviews, drafting of manuscripts) will be conducted at NUS.
The study comprises of two components: (1) quantitative and (2) qualitative research.
1) Quantitative Study Design: Clinical-Effectiveness The proposed study design will be a two-arm (intervention-control), single-blind (evaluator-blind) randomised controlled trial to evaluate the clinical effectiveness of iCBT for anxiety and depression in Singapore's primary care and community setting. 390 participants will be recruited and randomised 1:1 to intervention (N = 195) or control (N = 195) groups using stratified block randomisation.
Participants in the intervention group will be required to download the iCBT mobile application on their mobile devices. The guided iCBT intervention will consist of 8 weeks of 8 online modules (1 module per week) covering core CBT techniques, including interactive exercises and homework assignments delivered via the iCBT programme on a mobile application. There is no prescribed duration for each module, participants may complete the weekly exercises at their own pace within the eight-week period. COMIT counsellors will schedule regular check-ins with the participants at Week 3, 5, and end of Week 8 via face-to-face or video sessions to introduce the treatment rationale, practise skills, and assess the participants' progress. The control group will continue usual care, including but not limited to care from GP consultations, standard face-to-face CBT, and/or referral to other mental health services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quantitative Study - Patients
- •Inclusion Criteria:
- •Age ≥21 years
- •Tier 2 - 3 depression and/or anxiety based on PHQ-9 and GAD-7 scores
- •PHQ-9 score of 5 to 19
- •GAD-7 score of 5 to 14
- •Able to provide informed consent
排除标准
- •Unable to read or understand English (Primary 6 level)
- •Unable to use the internet (e.g. due to lack of internet access or insufficient digital literacy)
- •Does not possess a mobile device or is not able to access the iCBT application
- •Actively experiencing psychosis
- •Suspected with personality disorder
- •Primary concern is obsessive compulsive disorder (OCD)
- •Tier 4 patients with severe depression or anxiety
- •PHQ-9 score of 20 and above
- •GAD-7 score of 15 and above
- •Any suicidal risk or ideation
- •PHQ-9 Question 9 score of more than 2
- •Qualitative Study - Service Providers
- •Inclusion Criteria:
- •Are currently or previously have been involved in the delivery, supervision, or implementation of the iCBT programme
- •Have had direct experience supporting patients enrolled in the study
- •Able to provide informed consent
- •Exclusion Criteria:
- •Have no direct involvement in the iCBT programme; or
- •Have had insufficient exposure to the programme, defined as managing fewer than one referred case or less than one month of involvement at the time of recruitment.
- •Conflict of interest or Supervisory Hierarchy Concerns - Individuals whose participation may create perceived coercion or introduce bias
- •Inability to provide informed consent
研究组 & 干预措施
iCBT intervention arm
iCBT intervention arm: Participants undergo 8 weeks of 8 online modules (1 module per week) covering core CBT techniques, including interactive exercises and homework assignments delivered via the iCBT programme on a mobile application. COMIT counsellors will schedule regular check-ins with participants at Week 3, 5, and end of Week 8 via video or face-to-face sessions.
干预措施: Internet-delivered cognitive behavioural therapy (iCBT) (Behavioral)
Control arm
The control group will continue usual care, including but not limited to care from GP consultations, standard face-to-face CBT, and/or referral to other mental health services.
结局指标
主要结局
Change in the depression scores (PHQ-9) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
时间窗: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Depression severity is assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, where 0 indicates no depressive symptoms and 27 indicates the most severe depressive symptoms.
Change in the anxiety scores (GAD-7) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
时间窗: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Anxiety severity is assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Total scores range from 0 to 21, where 0 indicates no anxiety symptoms and 21 indicates the most severe anxiety symptoms.
Change in the functional scores (WHODAS 2.0) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
时间窗: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Disability and functional impairment are assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Total scores range from 0 to 48, where 0 indicates no disability and 48 indicates full disability.
次要结局
- Change in Quality-Adjusted Life Years (QALYs) scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months(Baseline, 5 weeks, 8 weeks, 3 months, 6 months)
- Change in health and social care service utilization and associated costs via CSRI from baseline at: 8 weeks, 3 months, 6 months(Baseline, 8 weeks, 3 months, 6 months)
- Change in self-rated health scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months(Baseline, 5 weeks, 8 weeks, 3 months, 6 months)
研究者
Gerald Koh
Principal Investigator
National University of Singapore