- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532551
Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
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:
- 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.
Study Overview
Status
Intervention / Treatment
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.
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:
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alvin K.Y. Neo, MBBS (Honours), MRCP (UK)
- Phone Number: 6597569541
- Email: alvin.neo@moht.com.sg
Study Contact Backup
- Name: Nicole S.Y. Chia, BA(Communication & Psychology)
- Phone Number: 6581267277
- Email: nicole.chia@moht.com.sg
Study Locations
-
-
-
Singapore, Singapore, 210052
- Recruiting
- [Viriya] Mental Wellness Hub
-
Contact:
- Viriya
- Phone Number: 6562561311
- Email: mwh@viriya.org.sg
-
Singapore, Singapore, 540193
- Recruiting
- [Allkin] Integrated Service Centre @ Sengkang 193
-
Contact:
- Allkin
- Email: mentalhealthservice@allkin.org.sg
-
Singapore, Singapore, 680280
- Recruiting
- [Fei Yue] Family Service Centre (Choa Chu Kang)
-
Contact:
- Fei Yue
- Phone Number: 6560117658
- Email: comit@fycs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Quantitative Study - Patients
Inclusion Criteria:
- Age ≥21 years
Tier 2 - 3 depression and/or anxiety based on PHQ-9 and GAD-7 scores
- PHQ-9 score of 5 to 19
- GAD-7 score of 5 to 14
- Able to provide informed consent
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
- PHQ-9 score of 20 and above
- GAD-7 score of 15 and above
Any suicidal risk or ideation
- PHQ-9 Question 9 score of more than 2
- Qualitative Study - Service Providers
Inclusion Criteria:
- Are currently or previously have been involved in the delivery, supervision, or implementation of the iCBT programme
- Have had direct experience supporting patients enrolled in the study
- Able to provide informed consent
Exclusion Criteria:
- Have no direct involvement in the iCBT programme; or
- Have had insufficient exposure to the programme, defined as managing fewer than one referred case or less than one month of involvement at the time of recruitment.
- Conflict of interest or Supervisory Hierarchy Concerns - Individuals whose participation may create perceived coercion or introduce bias
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: iCBT intervention arm
iCBT intervention arm: Participants undergo 8 weeks of 8 online modules (1 module per week) covering core CBT techniques, including interactive exercises and homework assignments delivered via the iCBT programme on a mobile application.
COMIT counsellors will schedule regular check-ins with participants at Week 3, 5, and end of Week 8 via video or face-to-face sessions.
|
Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression
Other Names:
|
|
No Intervention: Control arm
The control group will continue usual care, including but not limited to care from GP consultations, standard face-to-face CBT, and/or referral to other mental health services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
Baseline, 5 weeks, 8 weeks, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
|
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
|
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
Time Frame: Baseline, 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured qualitative study on acceptability and user experience regarding iCBT for selected participants in the intervention arm
Time Frame: Post treatment (after Week 8)
|
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.
|
Post treatment (after Week 8)
|
|
Semi-structured qualitative study on service providers' acceptability and experience with iCBT
Time Frame: Post treatment (after Week 8)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerald C.H. Koh, MBBS, FCFP, PhD, Saw Swee Hock School of Public Health, National University of Singapore
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
- World Health Organisation. Depressive Disorder (Depression) [Internet]. [31st Mar 2023; cited 28th Oct 2024]
- World Health Organisation. Anxiety Disorders [Internet]. [27th Sep 2023; cited 28th Oct 2024]
- R Hirschman. Mental health professionals per 100,000 population in Singapore [Internet]. Statista [updated 29th May 2024, cited 29th Oct 2024]
- Infocomm Media Development Authority Singapore. Singapore digital society report 2023 [Internet]. Singapore: IMDA [cited 29th Oct 2024]
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2025-562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.