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| Name | Class |
|---|---|
| Ministry of Health, Singapore | OTHER_GOV |
| Agency for Integrated Care, Singapore | OTHER |
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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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-delivered cognitive behavioural therapy (iCBT) | Behavioral | Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, 5 weeks, 8 weeks, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 5 weeks, 8 weeks, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Quantitative Study - Patients
Inclusion Criteria:
Age ≥21 years
Tier 2 - 3 depression and/or anxiety based on PHQ-9 and GAD-7 scores
Able to provide informed consent
Exclusion Criteria:
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
Any suicidal risk or ideation
Qualitative Study - Service Providers
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvin K.Y. Neo, MBBS (Honours), MRCP (UK) | Contact | 6597569541 | alvin.neo@moht.com.sg | |
| Nicole S.Y. Chia, BA(Communication & Psychology) | Contact | 6581267277 | nicole.chia@moht.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Gerald C.H. Koh, MBBS, FCFP, PhD | Saw Swee Hock School of Public Health, National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| [Viriya] Mental Wellness Hub | Singapore | 210052 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38033104 | Background | 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. | |
| 31197373 |
| Label | URL |
|---|---|
| World Health Organisation. Depressive Disorder (Depression) \[Internet\]. \[31st Mar 2023; cited 28th Oct 2024\] | View source |
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Demographics, primary outcome measures, secondary outcome measures, and qualitative measures
Unending from date of publication
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2026 |
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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).
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|
| 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. | 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. | Baseline, 5 weeks, 8 weeks, 3 months, 6 months |
| 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:
| Post treatment (after Week 8) |
| [Allkin] Integrated Service Centre @ Sengkang 193 | Singapore | 540193 | Singapore |
|
| [Fei Yue] Family Service Centre (Choa Chu Kang) | Singapore | 680280 | Singapore |
|
| Subramaniam 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. |
| 16717171 | Background | Spitzer 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. |
| 11556941 | Background | Kroenke 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. |
| 33782057 | Background | Page 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. |
| 34367671 | Background | Holtrop 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. |
| 33822737 | Background | Sorkin 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. |
| 34393903 | Background | Lu 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. |
| 33471111 | Background | Karyotaki 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. |
| 34433988 | Background | Bentley 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. |
| 23459093 | Background | Hofmann 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. |
| 29451967 | Background | Carpenter 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. |
| 30947763 | Background | Subramaniam 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. |
| 38920221 | Background | Chua 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. |
| 33057931 | Background | Shafie 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. |
| World Health Organisation. Anxiety Disorders \[Internet\]. \[27th Sep 2023; cited 28th Oct 2024\] | View source |
| R Hirschman. Mental health professionals per 100,000 population in Singapore \[Internet\]. Statista \[updated 29th May 2024, cited 29th Oct 2024\] | View source |
| Infocomm Media Development Authority Singapore. Singapore digital society report 2023 \[Internet\]. Singapore: IMDA \[cited 29th Oct 2024\] | View source |
| Mar 23, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form for patients | Feb 19, 2026 | Mar 23, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form for providers | Feb 19, 2026 | Mar 23, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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