Display options
Cite
Sin J, Henderson C, Cornelius V, et al. COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial. BMC Psychiatry. 2020;20(1):129doi: 10.1186/s12888-020-02528-w.
Sin, J., Henderson, C., Cornelius, V., Chen, T., Elkes, J., Woodham, L. A., Hernández, A. S., Spence-Polin, D., Batchelor, R., & Gillard, S. (2020). COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial. BMC psychiatry, 20(1), 129. https://doi.org/10.1186/s12888-020-02528-w
Sin, Jacqueline, et al. "COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial." BMC psychiatry vol. 20,1 (2020): 129. doi: https://doi.org/10.1186/s12888-020-02528-w
Sin J, Henderson C, Cornelius V, Chen T, Elkes J, Woodham LA, Hernández AS, Spence-Polin D, Batchelor R, Gillard S. COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial. BMC Psychiatry. 2020 Mar 17;20(1):129. doi: 10.1186/s12888-020-02528-w. PMID: 32183772; PMCID: PMC7079455.
Copy Download .nbib Format: NLM
Share it on

BMC Psychiatry. 2020 Mar 17;20(1):129. doi: 10.1186/s12888-020-02528-w.

COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial.

BMC psychiatry

Jacqueline Sin, Claire Henderson, Victoria Cornelius, Tao Chen, Jack Elkes, Luke A Woodham, Aurora Sesé Hernández, Dominique Spence-Polin, Rachel Batchelor, Steve Gillard

Affiliations

  1. Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, England, UK. [email protected].
  2. School of Psychology & Clinical Language Sciences, University of Reading, Earley Gate, Reading, RG6 6AL, England, UK. [email protected].
  3. Health Service & Population Research Department, King's College London, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, England, UK.
  4. Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, England, W12 7RH, UK.
  5. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, England, UK.
  6. Institute of Medical and Biomedical Education, St George's, University of London, Cranmer Terrace, London, SW17 0RE, England, UK.
  7. Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, England, UK.

PMID: 32183772 PMCID: PMC7079455 DOI: 10.1186/s12888-020-02528-w

Abstract

BACKGROUND: Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends ('carers') provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers.

METHODS: This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants' usage patterns.

DISCUSSION: The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers.

TRIAL REGISTRATION: The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018).

Keywords: Carers; Digital interventions; Psychosis; RCT; Wellbeing; eHealth; eMentalHealth

References

  1. Soc Psychiatry Psychiatr Epidemiol. 2016 Sep;51(9):1247-55 - PubMed
  2. J Med Internet Res. 2019 Aug 06;21(8):e14374 - PubMed
  3. J Med Internet Res. 2009 Apr 24;11(2):e13 - PubMed
  4. Ann Intern Med. 2017 Jul 4;167(1):40-47 - PubMed
  5. Eur J Health Econ. 2013 Jul;14 Suppl 1:S1-3 - PubMed
  6. Aust Health Rev. 2010 May;34(2):144-7 - PubMed
  7. Br J Psychiatry Suppl. 2013 Apr;55:s45-8 - PubMed
  8. BMJ Open. 2017 Jul 18;7(7):e016965 - PubMed
  9. JAMA. 1995 Feb 1;273(5):408-12 - PubMed
  10. Stat Methods Med Res. 2005 Aug;14(4):327-47 - PubMed
  11. Br J Psychiatry. 2015 Apr;206(4):268-74 - PubMed
  12. J Med Internet Res. 2005 Mar 31;7(1):e11 - PubMed
  13. Can J Psychiatry. 2010 Jul;55(7):440-8 - PubMed
  14. J Med Internet Res. 2009 Apr 03;11(2):e9 - PubMed
  15. BMC Psychiatry. 2013 Apr 26;13:123 - PubMed
  16. Clin Psychol Rev. 2018 Mar;60:109-125 - PubMed
  17. Soc Psychiatry Psychiatr Epidemiol. 1996 Jun;31(3-4):137-48 - PubMed
  18. J Telemed Telecare. 2008;14(3):154-6 - PubMed
  19. Br J Psychiatry. 2014 Sep;205(3):197-203 - PubMed
  20. Psychol Med. 2013 Apr;43(4):865-79 - PubMed
  21. Psychiatry Res. 2002 Apr 15;109(3):265-79 - PubMed
  22. BMJ. 2011 Feb 07;342:d40 - PubMed
  23. J Clin Psychiatry. 2013 Dec;74(12):e1145-62 - PubMed
  24. Health Qual Life Outcomes. 2012 Dec 27;10:156 - PubMed
  25. Digit Health. 2019 Aug 28;5:2055207619871148 - PubMed
  26. Health Qual Life Outcomes. 2007 Nov 27;5:63 - PubMed
  27. J Med Internet Res. 2012 Dec 31;15(1):e2 - PubMed
  28. Clin Psychol Rev. 2017 Aug;56:13-24 - PubMed
  29. Psychol Med. 2011 Dec;41(12):2581-91 - PubMed
  30. Cochrane Database Syst Rev. 2010 Dec 08;(12):CD000088 - PubMed
  31. Psychol Med. 1994 Aug;24(3):707-18 - PubMed
  32. J Med Internet Res. 2018 Aug 28;20(8):e257 - PubMed
  33. J Med Internet Res. 2011 Dec 31;13(4):e126 - PubMed
  34. J Med Internet Res. 2018 Jul 03;20(7):e10668 - PubMed

MeSH terms

Publication Types

Grant support