Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore

NCT07532551 | Not Yet Recruiting

• 1 other identifier: NUS-IRB-2025-562
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 3

Brief 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. iCBT is a digital adaptation of traditional CBT that leverages digital platforms to deliver similar therapeutic interventions. iCBT encompasses structured programmes that provide users with tools and techniques to manage mental health issues such as depression and anxiety. The digital format ensures timely access to CBT and typically includes interactive modules, videos, self-assessment tools, and virtual therapist support. This study aims to evaluate the effectiveness of iCBT in reducing symptoms of anxiety and depression, as well as its cost-effectiveness and acceptability in local context. The main questions it aims to answer are:

1. 1.Do participants receiving iCBT show a reduction in symptoms of anxiety and/or depression, and does the effectiveness of iCBT vary based on individual user characteristics?
2. 2.What are the factors that influence the acceptance, adoption, and engagement rates of iCBT among Singaporeans?
3. 3.Is iCBT more cost-effective as compared to usual care?
4. 4.Undergo guided iCBT intervention consisting of 8 weeks of online modules covering core CBT techniques
5. 5.Counsellors will schedule 3 regular check-ins
6. 6.Questionnaires will be administered at 5 timepoints
7. 7.Selected participants will be invited for a semi-structured interview to assess their experiences with iCBT
8. 8.Continue usual care
9. 9.Questionnaires will be administered at 5 timepoints

Conditions

Depression and/or Anxiety in the Mild-to-moderate Range; Cognitive Behavioral Therapy

Keywords

internet-delivered cognitive behavioural therapy; cognitive behavioural therapy; CBT; iCBT; anxiety; depression

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Change in Quality-Adjusted Life Years (QALYs) scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months

  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

  Baseline, 8 weeks, 3 months, 6 months

• Change in self-rated health scores from baseline at: 5 weeks, 8 weeks, 3 months, 6 months

  Baseline, 5 weeks, 8 weeks, 3 months, 6 months

Other Outcomes (2)

• Semi-structured qualitative study on acceptability and user experience regarding iCBT for selected participants in the intervention arm

  Post treatment (after Week 8)

• Semi-structured qualitative study on service providers' acceptability and experience with iCBT

  Post treatment (after Week 8)

Study Arms (2)

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.

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.

Interventions

Internet-delivered cognitive behavioural therapy (iCBT) BEHAVIORAL

Guided iCBT in Singapore for mild-to-moderate anxiety and/or depression

Also known as: iCBT, Guided iCBT

iCBT intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National University of Singapore: lead
• MOH Office for Healthcare Transformation (MOHT), Singapore: collaborator
• Agency for Integrated Care, Singapore: collaborator

Study Sites (3)

[Viriya] Mental Wellness Hub

Singapore, 210052, Singapore

Location

[Allkin] Integrated Service Centre @ Sengkang 193

Singapore, 540193, Singapore

Location

[Fei Yue] Family Service Centre (Choa Chu Kang)

Singapore, 680280, Singapore

Location

Related Publications (15)

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  PMID: 38033104 BACKGROUND

• 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.

  PMID: 31197373 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 34393903 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 38920221 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.

  PMID: 33057931 BACKGROUND

Related 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 \[cited 29th Oct 2024\]

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gerald C.H. Koh, MBBS, FCFP, PhD

  Saw Swee Hock School of Public Health, National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Unending from date of publication
• Access Criteria: The investigator(s) and participating institution(s) agree to provide direct access to source data and documents as necessary for the purposes of study-related monitoring, quality assurance audits, Institutional Review Board (IRB)/Ethics Committee review, and inspections by applicable regulatory authorities.

Locations

SG (3)