Protocol investigating the clinical outcomes and cost-effectiveness of cognitive-behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial

Shireen Patel, Sam Malins, Boliang Guo, Marilyn James, Joe Kai, Catherine Kaylor-Hughes, Emma Rowley, Jayne Simpson, David Smart, Michelle Stubley, Helen Tyrer, Richard Morriss, Shireen Patel, Sam Malins, Boliang Guo, Marilyn James, Joe Kai, Catherine Kaylor-Hughes, Emma Rowley, Jayne Simpson, David Smart, Michelle Stubley, Helen Tyrer, Richard Morriss

Abstract

Background: Health anxiety and medically unexplained symptoms cost the National Health Service (NHS) an estimated £3 billion per year in unnecessary costs with little evidence of patient benefit. Effective treatment is rarely taken up due to issues such as stigma or previous negative experiences with mental health services. An approach to overcome this might be to offer remotely delivered psychological therapy, which can be just as effective as face-to-face therapy and may be more accessible and suitable.

Aims: To investigate the clinical outcomes and cost-effectiveness of remotely delivered cognitive-behavioural therapy (CBT) to people with high health anxiety repeatedly accessing unscheduled care (trial registration: NCT02298036).

Method: A multicentre randomised controlled trial (RCT) will be undertaken in primary and secondary care providers of unscheduled care across the East Midlands. One hundred and forty-four eligible participants will be equally randomised to receive either remote CBT (6-12 sessions) or treatment as usual (TAU). Two doctoral research studies will investigate the barriers and facilitators to delivering the intervention and the factors contributing to the optimisation of therapeutic outcome.

Results: This trial will be the first to test the clinical outcomes and cost-effectiveness of remotely delivered CBT for the treatment of high health anxiety.

Conclusions: The findings will enable an understanding as to how this intervention might fit into a wider care pathway to enhance patient experience of care.

Declaration of interest: None.

Copyright and usage: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-commercial, No Derivatives (CC BY-NC-ND) licence.

Figures

Fig. 1. Study flow chart comparing remotely…
Fig. 1. Study flow chart comparing remotely delivered cognitive–behavioural therapy (CBT) v. treatment as usual (TAU) for high utilisers of healthcare with high health anxiety. HAI, Health Anxiety Inventory.

References

    1. Bermingham S, Cohen A, Hague J, Parsonage M. The cost of somatisation among the working-age population in England for the year 2008–2009. Ment Health Fam Med 2010; 7: 71–84.
    1. Seivewright H, Salkovskis P, Green J, Mullan N, Behr G, Carlin E, et al. Prevalence and service implications of health anxiety in genitourinary medicine clinics. Int J STD AIDS 2004; 15: 519–22.
    1. Reid S, Crayford T, Patel A, Wessely S, Hotopf M. Frequent attenders in secondary care: a 3-year follow-up study of patients with medically unexplained symptoms. Psychol Med 2003; 33: 519–24.
    1. Warwick HM, Clark DM, Cobb AM, Salkovskis PM. A controlled trial of cognitive-behavioural treatment of hypochondriasis. Br J Psychiatry 1996; 169: 189–95.
    1. NHS England. Quality Premium: 2013/14 Guidance for CCGs. NHS England, 2013.
    1. Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JA, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther 2014; 58: 65–74.
    1. Tyrer P, Cooper S, Salkovskis P, Tyrer H, Crawford M, Byford S. et al. Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial. Lancet 2014; 383: 219–25.
    1. Williams C, House A. Cognitive behaviour therapy for health anxiety. Lancet 2014; 383: 190–1.
    1. Department of Health Talking Therapies: A Four-Year Plan of Action. Department of Health, 2011.
    1. Tyrer H, Tyrer P, Lovett I. Adapted cognitive-behavior therapy for medically unexplained symptoms in secondary care reduces hospital contacts. Psychosomatics 2011; 52: 194–7.
    1. Clark DM, Layard R, Smithies R. Improving Access to Psychological Therapy: Initial Evaluation of the Two Demonstration Sites. LSE Centre for Economics Performance, 2008.
    1. Glover G, Webb M, Evison E. Improving Access to Psychological Therapies: A Review of the Progress Made by Sites in the First Roll-Out Year. North East Public Health Observatory, 2010.
    1. Hedman E, Axelsson E, Görling A, Ritzman C, Ronnheden M, El Alaoui S, et al. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry 2014; 205: 307–14.
    1. Hedman E, Lekander M, Ljótsson B, Lindefors N, Rück C, Hofmann SG, et al. Sudden gains in internet-based cognitive behaviour therapy for severe health anxiety. Behav Res Ther 2014; 54: 22–9.
    1. Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, et al. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry 2015; 206: 263–5.
    1. Bee PE, Bower P, Lovell K, Gilbody S, Richards D, Gask L. et al. Psychotherapy mediated by remote communication technologies: a meta-analytic review. BMC Psychiatry 2008; 8: 60.
    1. Lintvedt OK, Sorensen K, Ostvik AR, Verplanken B. Wang CE. The need for web-based cognitive behaviour therapy among university students. J Technol Hum Serv 2008; 26: 239–58.
    1. Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med 2002; 321: 843–53.
    1. Blackburn IM, James IA, Milne DL, Baker C, Standart S, Garland A. et al. The revised Cognitive Therapy Scale (CTS-R): psychometric properties. Behav Cogn Psychother 2001; 29: 431–46.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006; 166: 1092–7.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med 2002; 64: 258–66.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16: 606–13.
    1. Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry 2002; 180: 461–4.
    1. EuroQol Group EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199–208.
    1. Ware JE, Kezinski M, Dewey JE. How to Score Version Two of the SF-36 Health Survey. Quality Matrix, 2000.
    1. Beecham J, Knapp M. Costing psychiatric interventions In Measuring Mental Health Needs (ed. Thornicroft G): 200–24. Gaskell, 2001.
    1. First MB, Williams JB, Karg RS, Spitzer MD. Structured Clinical Interview for DSM-5 Disorders. American Psychiatric Association, 2016.
    1. Scott AIF, Freeman CPL. Edinburgh primary care depression study: treatment outcome, patient satisfaction and cost after 16 weeks. BMJ 1992; 304: 883–7.
    1. Miller SD, Duncan BL, Brown J, Sparks J, Claud D. The outcome ratingscale: a preliminary study of the reliability, validity, and feasibility of a brief visual analog measure. J Brief Ther 2003; 2: 91–100.
    1. Duncan BL, Miller SD, Sparks J, Claud D, Reynolds L, Brown J, et al. The Session Rating Scale: preliminary psychometric properties of a “working” alliance measure. J Brief Ther 2003; 3: 3–12.
    1. Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the Working Alliance Inventory. Psychother Res 2006; 16: 12–25.
    1. Carpenter J, Goldstein H, Kenward MG. REALCOM-IMPUTE software for multilevel multiple imputation with mixed response types. J Stat Software 2011; 5: 1–14.
    1. Morriss R, Marttunnen S, Garland A, Nixon N, McDonald R, Sweeney T, et al. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder. BMC Psychiatry 2010; 10: 100.
    1. Rowley E, Currie G, Morriss R, Schneider J. Research into practice: Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for Nottinghamshire, Derbyshire, Lincolnshire (NDL). Implement Sci 2012; 4: 40.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006; 3: 77–101.
    1. Morriss R, Kai J, Atha C, Avery A, Bayes S, Franklin M, et al. Persistent frequent attenders in primary care: costs, reasons for attendance, organisation of care and potential for cognitive behavioural therapeutic intervention. BMC Fam Pract 2012; 13: 39.

Source: PubMed

3
Subscribe