- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457801
CARE Study for Paramedics in Singapore
Cognitive Training And Resilience Education (CARE) for Paramedics on the Frontlines of the COVID-19 Epidemic: A Randomised Controlled Trial in Singapore
The purpose of this study is to compare the effectiveness of two different online education courses (Oxford-Online and Mind-Online) for preventing stress related conditions among paramedics who have been working during a period of COVID-19 occurrence in Singapore.
The study aims to:
- Compare the efficacy of a locally-adapted version of internet-delivered cognitive training for resilience (Oxford Online) to an existing educational online training (Mind Online) on depressive symptom severity
- Compare the efficacy of Oxford Online to Mind Online for improving posttraumatic stress symptoms, resilience, general psychological distress, anxiety symptoms, social support, work engagement, and health-related quality of life
Participants will:
- Complete an online battery of baseline questionnaires
- Be randomised to receive 6 modules of either Oxford Online or Mind Online, delivered once per week over a 6-week period
- Complete the same online questionnaire battery immediately following the intervention, and again at the 6-month and 12-month follow up
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1 (Primary): To compare the efficacy of a locally-adapted version of internet-delivered cognitive training for resilience (Oxford Online) to an existing educational online training (Mind Online) on depressive symptom severity in a sample of paramedics recruited during the COVID-19 pandemic in Singapore.
Aim 2 (Secondary): To compare the efficacy of Oxford-Online to Mind-Online for improving posttraumatic stress symptoms, resilience, general psychological distress, anxiety symptoms, social support, work engagement, and health-related quality of life in a sample of paramedics recruited during the COVID-19 pandemic in Singapore.
Aim 3 (Economic): To evaluate the incremental cost and cost-effectiveness of Oxford Online in a sample of paramedics recruited during the COVID-19 pandemic in Singapore.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 169857
- Duke-NUS Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 21 and above
- English speaking
- Employed or subcontracted as paramedics by SCDF who have been working during the COVID-19 pandemic
- Able to provide informed consent and read study materials
- Willing to enter randomised trial
Exclusion Criteria:
- Non-English speaking
- Not working during COVID-19 outbreak (e.g. on medical or maternity leave)
- Working as trainees, conscripts, medics or ambulance drivers
- Unwilling or unable to complete study procedures
- Unwilling to enter randomised trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Oxford-Online
The Oxford-Online programme is a series of six modules that targets cognitive predictors of depression and posttraumatic stress disorder.
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The Oxford Online programme targets cognitive predictors of depression and posttraumatic stress disorder.
The core information is delivered in six 20-minute modules over a 6-week period.
The modules include whiteboard videos to explain concepts, audio files for practicing concrete thinking, video testimonies and footage of paramedics on-call for use in experiential exercises.
A trained online wellbeing coordinator will provide individual email feedback on participants' responses and send brief automated message reminders.
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Active Comparator: Mind-Online
Mind-Online is a series of six modules available online where participants read information and advice about stress, depression, posttraumatic stress, sleep problems, anger, and mindfulness.
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Mind Online is a series of six modules available online where participants read information and advice about stress, depression, posttraumatic stress, sleep problems, anger, and mindfulness.
A trained online wellbeing coordinator will provide individual email feedback on participants' responses and send brief automated message reminders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Depression Symptoms
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Patient Health Questionnaire 9 (PHQ-9)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Posttraumatic Stress Symptoms
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Resilience
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Connor-Davidson Resilience Scale (CD-RISC)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Rumination
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Response to Intrusions Questionnaire (RIQ-s)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Anxiety Symptoms
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Generalized Anxiety Disorder seven item scale (GAD-7)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Psychological Distress
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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General Health Questionnaire (GHQ)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Burnout
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Physician Work-Life Study's Single Item (PWLS)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Social Support
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Multidimensional Scale of Perceived Social Support (MSPSS)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Work Engagement
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Utrecht Work Engagement Scale (UWES)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Health-related Quality of Life
Time Frame: Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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EuroQol 5 Dimensions Questionnaire (EQ-5D5L)
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Change from baseline at post-intervention (6-8 weeks after baseline), 6 months and 12 months post-intervention
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Change in Posttraumatic Growth
Time Frame: Change from baseline at 6 months and 12 months post-intervention (intervention completed 6-8 weeks after baseline).
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Posttraumatic Growth Inventory (PTGI-SF)
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Change from baseline at 6 months and 12 months post-intervention (intervention completed 6-8 weeks after baseline).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gayathri Devi Nadarajan, SGH
Publications and helpful links
General Publications
- Ehlers A, Clark DM, Hackmann A, McManus F, Fennell M, Herbert C, Mayou R. A randomized controlled trial of cognitive therapy, a self-help booklet, and repeated assessments as early interventions for posttraumatic stress disorder. Arch Gen Psychiatry. 2003 Oct;60(10):1024-32. doi: 10.1001/archpsyc.60.10.1024.
- Tan BYQ, Chew NWS, Lee GKH, Jing M, Goh Y, Yeo LLL, Zhang K, Chin HK, Ahmad A, Khan FA, Shanmugam GN, Chan BPL, Sunny S, Chandra B, Ong JJY, Paliwal PR, Wong LYH, Sagayanathan R, Chen JT, Ng AYY, Teoh HL, Ho CS, Ho RC, Sharma VK. Psychological Impact of the COVID-19 Pandemic on Health Care Workers in Singapore. Ann Intern Med. 2020 Aug 18;173(4):317-320. doi: 10.7326/M20-1083. Epub 2020 Apr 6. No abstract available.
- Wild J, Warnock-Parkes E, Grey N, Stott R, Wiedemann M, Canvin L, Rankin H, Shepherd E, Forkert A, Clark DM, Ehlers A. Internet-delivered cognitive therapy for PTSD: a development pilot series. Eur J Psychotraumatol. 2016 Nov 8;7:31019. doi: 10.3402/ejpt.v7.31019. eCollection 2016.
- Sung SC, Rush AJ. A timely investment: coordinated care for depression and anxiety disorders. Ann Acad Med Singap. 2011 Oct;40(10):436-8. No abstract available.
- Sung SC, Dryman MT, Marks E, Shear MK, Ghesquiere A, Fava M, Simon NM. Complicated grief among individuals with major depression: prevalence, comorbidity, and associated features. J Affect Disord. 2011 Nov;134(1-3):453-8. doi: 10.1016/j.jad.2011.05.017. Epub 2011 May 31.
- Sung SC, Haley CL, Wisniewski SR, Fava M, Nierenberg AA, Warden D, Morris DW, Kurian BT, Trivedi MH, Rush AJ; CO-MED Study Team. The impact of chronic depression on acute and long-term outcomes in a randomized trial comparing selective serotonin reuptake inhibitor monotherapy versus each of 2 different antidepressant medication combinations. J Clin Psychiatry. 2012 Jul;73(7):967-76. doi: 10.4088/JCP.11m07043. Epub 2012 May 29.
- Teo I, Sung SC, Cheung YB, Wong WHM, Abu Bakar Aloweni F, Ang HG, Ayre TC, Chai-Lim C, Chen R, Heng AL, Nadarajan GD, Ong MEH, Soh CR, Tan BH, Tan KBK, Tan BS, Tan MH, Tan PH, Tay KXK, Wijaya L, Tan HK. Burnout, anxiety and depression in healthcare workers during the early COVID-19 period in Singapore. Singapore Med J. 2024 Mar 1;65(Suppl 1):S26-S29. doi: 10.11622/smedj.2021156. Epub 2021 Oct 7. No abstract available.
- Yoon S, Goh H, Nadarajan GD, Sung S, Teo I, Lee J, Ong MEH, Graves N, Teo TL. Perceptions of Mobile Health Apps and Features to Support Psychosocial Well-being Among Frontline Health Care Workers Involved in the COVID-19 Pandemic Response: Qualitative Study. J Med Internet Res. 2021 May 31;23(5):e26282. doi: 10.2196/26282.
- Sung SC, L.Y., Chen AM, Chay J, Tewani K, Yeo LF, Tan HK. , Psychological Resilience among Healthcare Workers during the COVID-19 Pandemic in Singapore, in SingHealth Duke-NUS Scientific Congress. 2021: Singapore
- Tan BYQ, Kanneganti A, Lim LJH, Tan M, Chua YX, Tan L, Sia CH, Denning M, Goh ET, Purkayastha S, Kinross J, Sim K, Chan YH, Ooi SBS. Burnout and Associated Factors Among Health Care Workers in Singapore During the COVID-19 Pandemic. J Am Med Dir Assoc. 2020 Dec;21(12):1751-1758.e5. doi: 10.1016/j.jamda.2020.09.035. Epub 2020 Oct 5.
- Wild J, Smith KV, Thompson E, Bear F, Lommen MJ, Ehlers A. A prospective study of pre-trauma risk factors for post-traumatic stress disorder and depression. Psychol Med. 2016 Sep;46(12):2571-82. doi: 10.1017/S0033291716000532. Epub 2016 Jun 28.
- Wild, J., S. El-Salahi, and M. Degli-Eposti, The effectiveness of interventions aimed at improving wellbeing and resilience to stress in first responders: A systematic review. European Psychologist, in press
- Wild J, El-Salahi S, Tyson G, Lorenz H, Pariante CM, Danese A, Tsiachristas A, Watkins E, Middleton B, Blaber A, Ehlers A. Preventing PTSD, depression and associated health problems in student paramedics: protocol for PREVENT-PTSD, a randomised controlled trial of supported online cognitive training for resilience versus alternative online training and standard practice. BMJ Open. 2018 Dec 31;8(12):e022292. doi: 10.1136/bmjopen-2018-022292.
- Ehring T, Ehlers A, Glucksman E. Do cognitive models help in predicting the severity of posttraumatic stress disorder, phobia, and depression after motor vehicle accidents? A prospective longitudinal study. J Consult Clin Psychol. 2008 Apr;76(2):219-30. doi: 10.1037/0022-006X.76.2.219.
- Ehring T, Ehlers A, Glucksman E. Contribution of cognitive factors to the prediction of post-traumatic stress disorder, phobia and depression after motor vehicle accidents. Behav Res Ther. 2006 Dec;44(12):1699-716. doi: 10.1016/j.brat.2005.11.013. Epub 2006 Feb 7.
- Shepherd L, Wild J. Emotion regulation, physiological arousal and PTSD symptoms in trauma-exposed individuals. J Behav Ther Exp Psychiatry. 2014 Sep;45(3):360-7. doi: 10.1016/j.jbtep.2014.03.002. Epub 2014 Mar 26.
- Shepherd L, Wild J. Cognitive appraisals, objectivity and coping in ambulance workers: a pilot study. Emerg Med J. 2014 Jan;31(1):41-4. doi: 10.1136/emermed-2011-200511. Epub 2013 Jan 10.
- White R, Wild J. "Why" or "How": The Effect of Concrete Versus Abstract Processing on Intrusive Memories Following Analogue Trauma. Behav Ther. 2016 May;47(3):404-15. doi: 10.1016/j.beth.2016.02.004. Epub 2016 Feb 24.
- Pile V, Barnhofer T, Wild J. Updating versus Exposure to Prevent Consolidation of Conditioned Fear. PLoS One. 2015 Apr 22;10(4):e0122971. doi: 10.1371/journal.pone.0122971. eCollection 2015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/2516
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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