Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational University of Singapore
About this trial
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:
1. 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? 2. What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans? 3. 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:
1. Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques 2. Counsellors will schedule 3 regular check-ins 3. Questionnaires will be administered at 5 timepoints 4. Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT
Participants in the control group will:
1. Continue usual care 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Quantitative Study - Patients
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Internet-delivered cognitive behavioural therapy (iCBT)
BehavioralGuided iCBT in Singapore for mild-to-moderate anxiety and/or depression
Treatment groups
390 Participants
are divided into 2 treatment groupsGroup A: iCBT intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in the depression scores (PHQ-9) from baseline at: 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.
Time frame
Baseline, 5 weeks, 8 weeks, 3 months, 6 months2
Change in the anxiety scores (GAD-7) from baseline at: 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.
Time frame
Baseline, 5 weeks, 8 weeks, 3 months, 6 months3
Change in the functional scores (WHODAS 2.0) from baseline at: 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.
Time frame
Baseline, 5 weeks, 8 weeks, 3 months, 6 monthsSecondary outcomes
1
Change in Quality-Adjusted Life Years (QALYs) scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
Health-related quality of life is assessed using the EQ-5D-5L Index Value. Scores typically range from below 0 to 1, where 1 indicates full health, 0 indicates a state equivalent to death, and values below 0 indicate a health state considered worse than death.
Time frame
Baseline, 5 weeks, 8 weeks, 3 months, 6 months2
Change in health and social care service utilization and associated costs via CSRI from baseline at: 8 weeks, 3 months, 6 months
Health and social care service utilization and associated costs are assessed using an Adapted Client Service Receipt Inventory (CSRI). Outcomes are reported as the total estimated cost of services used in SGD, calculated by multiplying the self-reported frequency of each service by its established unit cost. There is no maximum score; higher total costs indicate greater service utilization and a higher economic burden.
Time frame
Baseline, 8 weeks, 3 months, 6 months3
Change in self-rated health scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
Self-rated health is assessed using the EQ-5D-5L Visual Analogue Scale (EQ VAS). Scores range from 0 to 100, where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
Time frame
Baseline, 5 weeks, 8 weeks, 3 months, 6 monthsOther outcomes
1
Semi-structured qualitative study on acceptability and user experience regarding iCBT for selected participants in the intervention arm
Acceptability and user experience are assessed via qualitative semi-structured interviews. Outcomes will be reported as key themes comprising of treatment experience, support from therapists, adherence and engagement, and suggestions for improvement. As this is a qualitative measure, there is no numerical scale or score.
Time frame
Post treatment (after Week 8)2
Semi-structured qualitative study on service providers' acceptability and experience with iCBT
Acceptability and user experience for service providers who have utilised iCBT are assessed via qualitative semi-structured interviews. Outcomes will be reported as key themes comprising of: * Initial perceptions and expectations * Experiences integrating iCBT into routine workflows * Perceived clinical value and patient suitability * Digital usability and training adequacy * Impact on workload, time and role boundaries * Organisational and system-level enablers or constraints * Reflections on sustainability and future improvements As this is a qualitative measure, there is no numerical scale or score.
Time frame
Post treatment (after Week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Singapore
Lead sponsor
Ministry of Health, Singapore
Collaborator
Agency for Integrated Care, Singapore
Collaborator
Source ClinicalTrials.gov