Depression and/or Anxiety in the Mild-to-moderate RangeNCT07532551
Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
A study testing Internet-delivered cognitive behavioural therapy (iCBT) in people with Depression and/or Anxiety in the Mild-to-moderate Range and Cognitive Behavioral Therapy, run by National University of Singapore at 3 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression and/or Anxiety in the Mild-to-moderate Range, Cognitive Behavioral Therapy
- What is being tested?
- Internet-delivered cognitive behavioural therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 3 sitesSingapore
- Study dates
- 2 Jul 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore3 sites, 3 recruiting
- Recruiting
[Viriya] Mental Wellness Hub
Singapore, 210052
Viriya, 6562561311, mwh@viriya.org.sg
- Recruiting
[Allkin] Integrated Service Centre @ Sengkang 193
Singapore, 540193
Allkin, mentalhealthservice@allkin.org.sg
- Recruiting
[Fei Yue] Family Service Centre (Choa Chu Kang)
Singapore, 680280
Fei Yue, 6560117658, comit@fycs.org
About this study
Official title: Assessing the Clinical and Cost Effectiveness of Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
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:
Read more
- 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.
Read the detailed description
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.
- 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:
- Pre-treatment/Baseline - Week 1
- Mid-treatment - Week 5
- Post-treatment - Week 8
- 3 months from baseline
- 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:
- RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), and
- Consolidated Framework for Implementation Research (CFIR) domains (intervention characteristics, inner setting, outer setting, individual characteristics, and implementation process). 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:
- Initial perceptions and expectations of iCBT
- 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
- Being tested
- Internet-delivered cognitive behavioural therapy (iCBT)
- Keywords
- internet-delivered cognitive behavioural therapy, cognitive behavioural therapy, CBT, iCBT, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavioural therapy (iCBT)Behavioural
Also called iCBT, Guided iCBT
Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression
| Study group | Role | What they receive |
|---|---|---|
| iCBT intervention arm | Experimental | 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. Receives: Behavioral: Internet-delivered cognitive behavioural therapy (iCBT) |
| Control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start2 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depression and/or Anxiety in the Mild-to-moderate RangeStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RCT sample size was determined a priori using a statistical power analysis to ensure adequate power to detect clinically meaningful differences between iCBT and usual care. The calculation was based on the co-primary outcomes of symptom reduction in depression (PHQ-9) and anxiety (GAD-7). Expected effect sizes and outcome variability were informed by prior studies reporting moderate-to-large effects in favour of iCBT. A superiority framework was adopted with equal allocation (1:1) between arms, using a two-sided significance level of α = 0.05 and 90% power (β = 0.10). Under these assumptions, the required sample size for the joint primary endpoint was N = 300 (150 iCBT, 150 usual care). To mitigate loss of power due to anticipated attrition, the sample size was inflated by 30%, yielding a final recruitment target of N = 390 (to preserve the effective analysable sample of \~300 participants at the primary endpoint).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, Agency for Integrated Care, Singapore
- Responsible party
- Principal investigator, Gerald Koh, National University of Singapore
- Investigators
- Gerald C.H. Koh, MBBS, FCFP, PhD, Principal investigator, Saw Swee Hock School of Public Health, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532551
- Sponsor's protocol ID
- NUS-IRB-2025-562
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics, primary outcome measures, secondary outcome measures, and qualitative measures
Publications
Abdin E, Seet V, Jeyagurunathan A, Tan SC, Mok YM, Verma S, Lee ES, Subramaniam M. Validation of the 12-item World Health Organization Disability Assessment Schedule 2.0 in individuals with schizophrenia, depression, anxiety, and diabetes in Singapore. PLoS One. 2023 Nov 30;18(11):e0294908. doi: 10.1371/journal.pone.0294908. eCollection 2023.
PubMed 38033104Subramaniam M, Abdin E, Vaingankar JA, Sagayadevan V, Shahwan S, Picco L, Chong SA. Validation of the World Health Organization Disability Assessment Schedule 2.0 among older adults in an Asian country. Singapore Med J. 2020 May;61(5):246-253. doi: 10.11622/smedj.2019049. Epub 2019 Jun 14.
PubMed 31197373Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hrobjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. doi: 10.1136/bmj.n71.
PubMed 33782057Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.
PubMed 34367671Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.
PubMed 33822737Lu SHX, Assudani HA, Kwek TRR, Ng SWH, Teoh TEL, Tan GCY. A Randomised Controlled Trial of Clinician-Guided Internet-Based Cognitive Behavioural Therapy for Depressed Patients in Singapore. Front Psychol. 2021 Jul 29;12:668384. doi: 10.3389/fpsyg.2021.668384. eCollection 2021.
PubMed 34393903Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364.
PubMed 33471111Bentley KH, Bernstein EE, Wallace B, Mischoulon D. Treatment for Anxiety and Comorbid Depressive Disorders: Transdiagnostic Cognitive-Behavioral Strategies. Psychiatr Ann. 2021 Aug;51(5):226-230. doi: 10.3928/00485713-20210414-01. Epub 2021 May 1.
PubMed 34433988Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
PubMed 23459093Carpenter JK, Andrews LA, Witcraft SM, Powers MB, Smits JAJ, Hofmann SG. Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials. Depress Anxiety. 2018 Jun;35(6):502-514. doi: 10.1002/da.22728. Epub 2018 Feb 16.
PubMed 29451967Subramaniam M, Abdin E, Vaingankar JA, Shafie S, Chua BY, Sambasivam R, Zhang YJ, Shahwan S, Chang S, Chua HC, Verma S, James L, Kwok KW, Heng D, Chong SA. Tracking the mental health of a nation: prevalence and correlates of mental disorders in the second Singapore mental health study. Epidemiol Psychiatr Sci. 2019 Apr 5;29:e29. doi: 10.1017/S2045796019000179.
PubMed 30947763Chua YCE, Lin YC, Lew JK, Wong SKW, Soon WSW, Wan J, Abdin E, Subramaniam M, Tang WE, Lee ES. Prevalence and risk factors of depression and anxiety in primary care. Ann Acad Med Singap. 2024 May 10;53(5):293-305. doi: 10.47102/annals-acadmedsg.2023195.
PubMed 38920221Shafie S, Subramaniam M, Abdin E, Vaingankar JA, Sambasivam R, Zhang Y, Shahwan S, Chang S, Jeyagurunathan A, Chong SA. Help-Seeking Patterns Among the General Population in Singapore: Results from the Singapore Mental Health Study 2016. Adm Policy Ment Health. 2021 Jul;48(4):586-596. doi: 10.1007/s10488-020-01092-5. Epub 2020 Oct 15.
PubMed 33057931
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical and Cost Effectiveness of Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
- ClinicalTrials.gov ID
- NCT07532551
- Acronym / sponsor ID
- NUS-IRB-2025-562
- Keywords
- internet-delivered cognitive behavioural therapy, cognitive behavioural therapy, CBT, iCBT, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, Agency for Integrated Care, Singapore
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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:
- Pre-treatment/Baseline - Week 1
- Mid-treatment - Week 5
- Post-treatment - Week 8
- 3 months from baseline
- 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:
- RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), and
- Consolidated Framework for Implementation Research (CFIR) domains (intervention characteristics, inner setting, outer setting, individual characteristics, and implementation process). 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:
- Initial perceptions and expectations of iCBT
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The RCT sample size was determined a priori using a statistical power analysis to ensure adequate power to detect clinically meaningful differences between iCBT and usual care. The calculation was based on the co-primary outcomes of symptom reduction in depression (PHQ-9) and anxiety (GAD-7). Expected effect sizes and outcome variability were informed by prior studies reporting moderate-to-large effects in favour of iCBT. A superiority framework was adopted with equal allocation (1:1) between arms, using a two-sided significance level of α = 0.05 and 90% power (β = 0.10). Under these assumptions, the required sample size for the joint primary endpoint was N = 300 (150 iCBT, 150 usual care). To mitigate loss of power due to anticipated attrition, the sample size was inflated by 30%, yielding a final recruitment target of N = 390 (to preserve the effective analysable sample of ~300 participants at the primary endpoint).
| Arm | Type | Receives |
|---|---|---|
| iCBT intervention arm | Experimental | Behavioral: Internet-delivered cognitive behavioural therapy (iCBT)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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- Qualitative Study - Service Providers
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive behavioural therapy (iCBT)Also: iCBT, Guided iCBTGuided iCBT in Singapore for mild-to-moderate anxiety and/or depression | Behavioural | iCBT intervention arm |
Primary outcome
Change in the depression scores (PHQ-9) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Quality-Adjusted Life Years (QALYs) scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months
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
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
Time frame: Baseline, 5 weeks, 8 weeks, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 38033104Abdin E, Seet V, Jeyagurunathan A, Tan SC, Mok YM, Verma S, Lee ES, Subramaniam M. Validation of the 12-item World Health Organization Disability Assessment Schedule 2.0 in individuals with schizophrenia, depression, anxiety, and diabetes in Singapore. PLoS One. 2023 Nov 30;18(11):e0294908. doi: 10.1371/journal.pone.0294908. eCollection 2023.
- Background: PubMed 31197373Subramaniam M, Abdin E, Vaingankar JA, Sagayadevan V, Shahwan S, Picco L, Chong SA. Validation of the World Health Organization Disability Assessment Schedule 2.0 among older adults in an Asian country. Singapore Med J. 2020 May;61(5):246-253. doi: 10.11622/smedj.2019049. Epub 2019 Jun 14.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 33782057Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hrobjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. doi: 10.1136/bmj.n71.
- Background: PubMed 34367671Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.
- Background: PubMed 33822737Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.
- Background: PubMed 34393903Lu SHX, Assudani HA, Kwek TRR, Ng SWH, Teoh TEL, Tan GCY. A Randomised Controlled Trial of Clinician-Guided Internet-Based Cognitive Behavioural Therapy for Depressed Patients in Singapore. Front Psychol. 2021 Jul 29;12:668384. doi: 10.3389/fpsyg.2021.668384. eCollection 2021.
- Background: PubMed 33471111Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364.
- Background: PubMed 34433988Bentley KH, Bernstein EE, Wallace B, Mischoulon D. Treatment for Anxiety and Comorbid Depressive Disorders: Transdiagnostic Cognitive-Behavioral Strategies. Psychiatr Ann. 2021 Aug;51(5):226-230. doi: 10.3928/00485713-20210414-01. Epub 2021 May 1.
- Background: PubMed 23459093Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
- Background: PubMed 29451967Carpenter JK, Andrews LA, Witcraft SM, Powers MB, Smits JAJ, Hofmann SG. Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials. Depress Anxiety. 2018 Jun;35(6):502-514. doi: 10.1002/da.22728. Epub 2018 Feb 16.
- World Health Organisation. Depressive Disorder (Depression) \[Internet\]. \[31st Mar 2023; cited 28th Oct 2024\]Link provided by the sponsor.
- World Health Organisation. Anxiety Disorders \[Internet\]. \[27th Sep 2023; cited 28th Oct 2024\]Link provided by the sponsor.
- R Hirschman. Mental health professionals per 100,000 population in Singapore \[Internet\]. Statista \[updated 29th May 2024, cited 29th Oct 2024\]Link provided by the sponsor.
- Infocomm Media Development Authority Singapore. Singapore digital society report 2023 \[Internet\]. Singapore: IMDA \[cited 29th Oct 2024\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographics, primary outcome measures, secondary outcome measures, and qualitative measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerald C.H. Koh, MBBS, FCFP, PhD principal investigator
Saw Swee Hock School of Public Health, National University of Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive behavioural therapy (iCBT) in people with Depression and/or Anxiety in the Mild-to-moderate Range and Cognitive Behavioral Therapy, run by National University of Singapore at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvin K.Y. Neo, MBBS (Honours), MRCP (UK) (6597569541, alvin.neo@moht.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the depression scores (PHQ-9) from baseline at: 5 weeks, 8 weeks, 3 months, 6 months (time frame: Baseline, 5 weeks, 8 weeks, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07532551, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.