An interventional study of Internet-delivered cognitive behavioural therapy (iCBT) in Depression and/or Anxiety in the Mild-to-moderate Range and Cognitive Behavioral Therapy, sponsored by National University of Singapore. Recruiting at 3 sites in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by National University of Singapore · Not applicable, Interventional, and Treatment
Among 34 studies in Depression with a site in Singapore — 14 open to participants now, 18 under way, none of them phase 3. Depression · Singapore.
Among the 34 studies in Depression with a site in Singapore, this one is the 4th largest by planned enrollment of the 25 interventional ones that give a count, is one of 5 that started in 2026, is one of 23 with no phase, reaches primary completion later than 12 of the 17 other live ones, and was the 29th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →14 of the 34 studies in Depression with a site in Singapore are open now. Recruiting first, the newest first:
Institute for Human Development and Potential (IHDP), Singapore · Sites in Singapore
Ages 21–75 · Healthy volunteers
KK Women's and Children's Hospital · Sites in Singapore
Ages 21–90
National University of Singapore · Sites in Singapore
Ages 21–64
Nanyang Technological University · Sites in Singapore
Ages 18–25 · Healthy volunteers
Institute of Mental Health, Singapore · Sites in Singapore
Ages 21+
A study can be open while its sites in Singapore have not opened yet or have stopped. Only those recruiting at a site in Singapore →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
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34 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 390 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 122 across the 25 interventional studies, 600 across the 9 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
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1 of 34 have an industry lead sponsor. The 10 most frequent:
National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.
National University of Singapore has 9 studies filed under Depression — fewer than ten, so there is no comparison to draw.
1 of the studies in Depression with a site in Singapore that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03408717KK Women's and Children's HospitalEvaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery | 2026-12-31 |
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Among the 34 studies in Depression with a site in Singapore, from their registry updates:
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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:
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:
Participants in the control group will:
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.
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.
All participants - both intervention and control groups - are required to complete up to 6 study visits over the course of 8 to 10 months, with each study visit taking approximately 1 to 2 hours for completion of questionnaires pertaining to primary and secondary outcome measures and/or counsellor check-ins, where applicable. The primary outcome measures include PHQ-9 and GAD-7 while secondary outcome measures include WHO Disability Assessment Schedule (WHODAS), patient satisfaction, healthcare utilisation, and cost-effectiveness. Please refer to the visit schedule below:
6 months from baseline
2a) Qualitative Study Design: Patients Qualitative components will also be incorporated into the project to explore patients' experiences, perceptions, and preferences regarding iCBT for depression and anxiety disorders. The qualitative study will provide deeper insights into the factors that influence treatment engagement, adherence, and satisfaction, which are not fully captured by quantitative measures alone.
Selected participants in the intervention group will be invited for a 1-hour semi-structured interview. Participants will be recruited using purposive sampling to ensure representation of key groups relevant to the implementation of iCBT. Specifically, patients will be selected from among those who have completed the iCBT programme, with a diverse subset based on age, gender, diagnosis (depression or anxiety), symptom severity, and completion status (completers and non-completers). This approach ensures variation in experiences and perspectives.
An interview guide will be developed to explore participants' experiences with iCBT and will include open-ended questions to allow participants to share their perspectives in their own words. This semi-structured interview will be conducted by qualified personnel assigned by the study team. This is planned as a 1-1 Interview. The interview will be conducted via video-conferencing, and the session will be audio-recorded and transcribed. During the semi-structured interview for the qualitative survey, participant quotes may be included in research publications or presentations, provided consent is obtained. All quotes will be anonymised.
Key topics to be covered in the interviews include:
- Treatment Experience: Participants' overall experience with iCBT.
- Support from Therapists: The value of guidance from therapists (if applicable) in their treatment journey, including the quality and frequency of support received.
- Adherence and Engagement: Factors that influenced their adherence to the programme, including motivation, barriers, and facilitators.
- Suggestions for Improvement: Recommendations for improving the iCBT programme based on their experience.
2b) Qualitative Study Design: Service Providers 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.
This qualitative descriptive study comprises of semi-structured in-depth interviews that adopt an implementation science lens, drawing on constructs from:
A purposive sampling approach will be used to ensure diversity across professional roles, practice settings and levels of experience with digital mental health interventions. Sampling will continue until thematic saturation is reached (anticipated n = 10-20 participants), consistent with prior qualitative iCBT implementation studies in healthcare services. Service providers will be recruited directly by the research team or through an email blast to ensure participation is entirely voluntary. Each interview will last approximately 45-60 minutes via secure videoconferencing or in person at AIC office, MOHT office or the COMIT site where the service provider is based at, and the session will be audio-recorded and transcribed. Participant quotes may be included in research publications or presentations, where all quotes will be anonymised.
Key topics to be covered in the interviews include:
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's planned enrollment of 390 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Quantitative Study - Patients
Inclusion Criteria:
Tier 2 - 3 depression and/or anxiety based on PHQ-9 and GAD-7 scores
Exclusion Criteria:
Tier 4 patients with severe depression or anxiety
Any suicidal risk or ideation
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Internet-delivered cognitive behavioural therapy (iCBT)
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.
Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression
Also known as: iCBT, Guided iCBT
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 months
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 months
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 months
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 months
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 months
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 months
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)
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)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Demographics, primary outcome measures, secondary outcome measures, and qualitative measures
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Unending from date of publication
Access criteria: The investigator(s) and participating institution(s) agree to provide direct access to source data and documents as necessary for the purposes of study-related monitoring, quality assurance audits, Institutional Review Board (IRB)/Ethics Committee review, and inspections by applicable regulatory authorities.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 20 months is close to that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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