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Open Access 01-12-2016 | Study protocol

The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Authors: Marc Serfaty, Michael King, Irwin Nazareth, Adrian Tookman, John Wood, Anna Gola, Trefor Aspden, Kathryn Mannix, Sarah Davis, Stirling Moorey, Louise Jones

Published in: Trials | Issue 1/2016

Abstract

Background

The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored.

Methods

People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy.

Discussion

This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community.

Trial registration

Controlled Trials ISRCTN07622709, registered 15 July 2011.

McDaniel JS, Musselman DL, Porter MR, Reed DA, Nemeroff CB. Depression in patients with cancer. Diagnosis, biology, and treatment. Arch Gen Psychiatry. 1995;52:89–99.CrossRefPubMed

Alexander PJ, Dinesh N, Vidyasagar MS. Psychiatric morbidity among cancer patients and its relationship with awareness of illness and expectations about treatment outcome. Acta Oncol. 1993;32:623–6.CrossRefPubMed

Bowers L, Boyle DA. Depression in patients with advanced cancer. Clin J Oncol Nurs. 2003;7:281–8. doi:10.1188/03.cjon.281-288.CrossRefPubMed

Lloyd-Williams M, Shiels C, Taylor F, Dennis M. Depression--an independent predictor of early death in patients with advanced cancer. J Affect Disord. 2009;113:127–32. doi:10.1016/j.jad.2008.04.002.CrossRefPubMed

Walker J, Hansen CH, Martin P, Symeonides S, Gourley C, Wall L, et al. Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer. Lancet Oncol. 2014;15:1168–76. doi:10.1016/s1470-2045(14)70343-2.CrossRefPubMed

Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, et al. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011;12:160–74. doi:10.1016/s1470-2045(11)70002-x.CrossRefPubMed

NICE. The treatment and management of depression in adults. 2009.

Taylor D, Meader N, Bird V, Pilling S, Creed F, Goldberg D. Pharmacological interventions for people with depression and chronic physical health problems: systematic review and meta-analyses of safety and efficacy. Br J Psychiatry. 2011;198:179–88. doi:10.1192/bjp.bp.110.077610.CrossRefPubMed

Walker J, Sawhney A, Hansen CH, Ahmed S, Martin P, Symeonides S, et al. Treatment of depression in adults with cancer: a systematic review of randomized controlled trials. Psychol Med. 2014;44:897–907. doi:10.1017/s0033291713001372.CrossRefPubMed

10.

Akechi T, Okuyama T, Onishi J, Morita T, Furukawa TA. Psychotherapy for depression among incurable cancer patients. Cochrane Database Syst Rev. 2008;2:Cd005537. doi:10.1002/14651858.CD005537.pub2.PubMed

11.

Price A, Hotopf M. The treatment of depression in patients with advanced cancer undergoing palliative care. Curr Opin Support Palliat Care. 2009;3:61–6. doi:10.1097/SPC.0b013e328325d17a.CrossRefPubMed

12.

Edelman S, Bell DR, Kidman AD. A group cognitive behaviour therapy programme with metastatic breast cancer patients. Psychooncology. 1999;8:295–305. doi:10.1002/(sici)1099-1611(199907/08)8:4<295::aid-pon386>3.0.co;2-y.CrossRefPubMed

13.

Savard J, Simard S, Giguere I, Ivers H, Morin CM, Maunsell E, et al. Randomized clinical trial on cognitive therapy for depression in women with metastatic breast cancer: psychological and immunological effects. Palliat Support Care. 2006;4:219–37.CrossRefPubMed

14.

Moorey S, Cort E, Kapari M, Monroe B, Hansford P, Mannix K, et al. A cluster randomized controlled trial of cognitive behaviour therapy for common mental disorders in patients with advanced cancer. Psychol Med. 2009;39:713–23. doi:10.1017/s0033291708004169.CrossRefPubMed

15.

Anderson T, Watson M, Davidson R. The use of cognitive behavioural therapy techniques for anxiety and depression in hospice patients: a feasibility study. Palliat Med. 2008;22:814–21. doi:10.1177/0269216308095157.CrossRefPubMed

16.

Thomas CM, Morris S. Cost of depression among adults in England in 2000. Br J Psychiatry. 2003;183:514–9.CrossRefPubMed

17.

Layard R, Clark D, Knapp M, Mayraz G. Cost-benefit analysis of psychological therapy. Natl Inst Econ Rev. 2007;202:90–8.CrossRef

18.

Holman AJ, Serfaty MA, Leurent BE, King MB. Cost-effectiveness of cognitive behaviour therapy versus talking and usual care for depressed older people in primary care. BMC Health Serv Res. 2011;11:33. doi:10.1186/1472-6963-11-33.CrossRefPubMedPubMedCentral

19.

Wiles N, Thomas L, Abel A, Barnes M, Carroll F, Ridgway N, et al. Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial. Health Technol Assess. 2014;18:1–167. doi:10.3310/hta18310.vii-viii.CrossRefPubMed

20.

Churchill R, Hunot V, Corney R, Knapp M, McGuire H, Tylee A, et al. A systematic review of controlled trials of the effectiveness and cost-effectiveness of brief psychological treatments for depression. Health Technol Assess. 2011;5:1–173.

21.

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22–33. quiz 4-57.PubMed

22.

Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993;88:791–804.CrossRefPubMed

23.

Kamboj SK, Tookman A, Jones L, Curran HV. The effects of immediate-release morphine on cognitive functioning in patients receiving chronic opioid therapy in palliative care. Pain. 2005;117:388–95. doi:10.1016/j.pain.2005.06.022.CrossRefPubMed

24.

Furukawa TA, McGuire H, Barbui C. Meta-analysis of effects and side effects of low dosage tricyclic antidepressants in depression: systematic review. BMJ. 2002;325:991.CrossRefPubMedPubMedCentral

25.

Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41:1284–92. doi:10.1097/01.mlr.0000093487.78664.3c.CrossRefPubMed

26.

Low J, Gessler S, Williams R, Daniells E, Brough V, Tookman A, et al. Screening for distress and depression in cancer patients: is ultrashort depression screening a valid measure in the UK? A prospective validation study. J Pain Symptom Manage. 2009;38:234–43. doi:10.1016/j.jpainsymman.2008.08.006.CrossRefPubMed

27.

Kroenke K, Spitzer RL. The PHQ-9: A new depression and diagnostic severity measure. Psychiatr Ann. 2002;32:509–21.CrossRef

28.

Serfaty MA, Haworth D, Blanchard M, Buszewicz M, Murad S, King M. Clinical effectiveness of individual cognitive behavioral therapy for depressed older people in primary care: a randomized controlled trial. Arch Gen Psychiatry. 2009;66:1332–40. doi:10.1001/archgenpsychiatry.2009.165.CrossRefPubMed

29.

Tutty S, Simon G, Ludman E. Telephone counseling as an adjunct to antidepressant treatment in the primary care system. A pilot study. Eff Clin Pract. 2000;3:170–8.PubMed

30.

Simon GE, Ludman EJ, Tutty S, Operskalski B, Von Korff M. Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial. JAMA. 2004;292:935–42. doi:10.1001/jama.292.8.935.CrossRefPubMed

31.

Simon GE, Ludman EJ, Rutter CM. Incremental benefit and cost of telephone care management and telephone psychotherapy for depression in primary care. Arch Gen Psychiatry. 2009;66:1081–9. doi:10.1001/archgenpsychiatry.2009.123.CrossRefPubMed

32.

Beck AT. Cognitive therapy of depression. New York: Guilford Press; 1979.

33.

James IA, Blackburn IM, Milne DL, Reichfelt FK. Moderators of trainee therapists’ competence in cognitive therapy. Br J Clin Psychol. 2001;40:131–41.CrossRefPubMed

34.

Vallis TM, Shaw BF, Dobson KS. The Cognitive Therapy Scale: psychometric properties. J Consult Clin Psychol. 1986;54:381–5.CrossRefPubMed

35.

Mannix KA, Blackburn IM, Garland A, Gracie J, Moorey S, Reid B, et al. Effectiveness of brief training in cognitive behaviour therapy techniques for palliative care practitioners. Palliat Med. 2006;20:579–84. doi:10.1177/0269216306071058.CrossRefPubMed

36.

Cort E, Moorey S, Hotopf M, Kapari M, Monroe B, Hansford P. Palliative care nurses’ experiences of training in cognitive behaviour therapy and taking part in a randomized controlled trial. Int J Palliat Nurs. 2009;15:290–8. doi:10.12968/ijpn.2009.15.6.42988.CrossRefPubMed

37.

Beck A, Steer R. Manual for the BDI-II. San Antonio: Psychological Corporation; 1996.

38.

Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561–71.CrossRefPubMed

39.

McLean LM, Jones JM, Rydall AC, Walsh A, Esplen MJ, Zimmermann C, et al. A couples intervention for patients facing advanced cancer and their spouse caregivers: outcomes of a pilot study. Psychooncology. 2008;17:1152–6. doi:10.1002/pon.1319.CrossRefPubMed

40.

Laidlaw T, Bennett BM, Dwivedi P, Naito A, Gruzelier J. Quality of life and mood changes in metastatic breast cancer after training in self-hypnosis or Johrei: a short report. Contemp Hypn. 2005;22:84–93. doi:10.1002/ch.27.CrossRef

41.

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282:1737–44.CrossRefPubMed

42.

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–13.CrossRefPubMedPubMedCentral

43.

Pinto-Meza A, Serrano-Blanco A, Penarrubia MT, Blanco E, Haro JM. Assessing depression in primary care with the PHQ-9: can it be carried out over the telephone? J Gen Intern Med. 2005;20:738–42. doi:10.1111/j.1525-1497.2005.0144.x.CrossRefPubMedPubMedCentral

44.

Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53–72.CrossRefPubMed

45.

EuroQol-Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.CrossRef

46.

King M, Jones L, Richardson A, Murad S, Irving A, Aslett H, et al. The relationship between patients’ experiences of continuity of cancer care and health outcomes: a mixed methods study. Br J Cancer. 2008;98:529–36. doi:10.1038/sj.bjc.6604164.CrossRefPubMedPubMedCentral

47.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–55.CrossRefPubMed

48.

Beecham JK, Knapp MRJ. Costing psychiatric options. In: Thornicroft G, Brewin C, Wing JK, editors. Measuring Mental Health Needs. London: Gaskell; 1992.

49.

Borkovek TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry. 1972;3:257–60.CrossRef

50.

DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, et al. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005;62:409–16. doi:10.1001/archpsyc.62.4.409.CrossRefPubMed

51.

Oei TPS, Free ML. Do Cognitive Behaviour Therapies Validate Cognitive Models of Mood Disorders? A Review of the Empirical Evidence. Int J Psychol. 1995;30:145–80. doi:10.1080/00207599508246564.CrossRef

52.

Scott J. Cognitive therapy for depression. Br Med Bull. 2001;57(1):101–13.CrossRefPubMed

53.

Tang TZ, DeRubeis RJ, Beberman R, Pham T. Cognitive changes, critical sessions, and sudden gains in cognitive-behavioral therapy for depression. J Consult Clin Psychol. 2005;73:168–72. doi:10.1037/0022-006x.73.1.168.CrossRefPubMed

54.

Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, et al. Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009;374:628–34. doi:10.1016/s0140-6736(09)61257-5.CrossRefPubMed

55.

King M, Davidson O, Taylor F, Haines A, Sharp D, Turner R. Effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy to treat patients with depression: randomised controlled trial. BMJ. 2002;324:947–50.CrossRefPubMedPubMedCentral

56.

StataCorp. Stata Statistical Software: Release 13. College Station: StataCorp LP; 2015.

57.

Drummond M, Sculpher M, Torrance G. Economic evaluation using decision analytic modelling (Chapter 9). In: Methods for the Economic Evaluation of Health Car Programmes. 3rd ed. Oxford: University Press; 2005.

58.

Curtis. Unit costs of health and social care 2008. Canterbury: Personal Social Services Research Unit; 2008.

59.

Jones L, Fitzgerald G, Leurent B, Round J, Eades J, Davis S, et al. Rehabilitation in advanced, progressive, recurrent cancer: a randomized controlled trial. J Pain Symptom Manage. 2013;46:315–25.e3. doi:10.1016/j.jpainsymman.2012.08.017.CrossRefPubMed

60.

Round J, Jones L, Morris S. Estimating the cost of caring for people with cancer at the end of life: A modelling study. Palliat Med. 2015;29:899–907.CrossRefPubMedPubMedCentral

Title: The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial
Authors: Marc Serfaty
Michael King
Irwin Nazareth
Adrian Tookman
John Wood
Anna Gola
Trefor Aspden
Kathryn Mannix
Sarah Davis
Stirling Moorey
Louise Jones
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1223-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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