Multi-centre Randomised Controlled Trial of Collaborative Care for Depression
Lead Research Organisation:
UNIVERSITY OF EXETER
Department Name: Psychology
Abstract
Depression causes misery to many people in the UK. Worldwide, more people are affected by depression than any other condition apart from heart disease. Depressed people find it difficult to work and engage in meaningful activity. Depression affects individuals, their families, friends and their communities.
Improving treatment for depression in primary care could have a major positive impact on patients, their families and society. Although effective treatments are available from GPs in primary care, many patients need additional support whilst they are being treated. Lack of this support often causes treatment to fail.
An exciting new way of organising treatment ? ?collaborative care? ? has been shown to be effective in the United States. This treatment involves allocating a specially trained worker ? a ?case manager? ? to patients with depression. The case manager works with patients, GPs and mental health specialists to agree individual treatment plans for patients. The case manager then keeps in close touch with patients to make this plan work. This plan includes regular telephone contact with patients, support to those who are taking medication and advice about psychological ways to improve depression. The case manager accesses regular advice from psychiatrists and psychologists and ensures that the patient?s GP is fully involved in the treatment plan.
Recently, three research groups in the UK have demonstrated that it may be possible to adapt these methods of working for the UK. These groups have now come together to plan a large clinical trial in the UK which will thoroughly test this new approach.
The research study will test collaborative care by allocating consenting patients to either collaborative care or to the care a patient would usually receive from their GP. We will carefully measure patients? symptoms of depression before the study and after four months to test if patients receiving collaborative care are more improved that those receiving usual care from their GP. We will also assess patients? symptoms again after 12 months. In addition, we will count the extent to which patients have used other health services and do an economic analysis to see if collaborative care is cost effective.
If, as we suspect, we are able to show that people receiving collaborative care improve more than people receiving usual care and that this is cost effective, we will ensure that collaborative care becomes the recommended way of supporting the treatment of people with depression in primary care.
Improving treatment for depression in primary care could have a major positive impact on patients, their families and society. Although effective treatments are available from GPs in primary care, many patients need additional support whilst they are being treated. Lack of this support often causes treatment to fail.
An exciting new way of organising treatment ? ?collaborative care? ? has been shown to be effective in the United States. This treatment involves allocating a specially trained worker ? a ?case manager? ? to patients with depression. The case manager works with patients, GPs and mental health specialists to agree individual treatment plans for patients. The case manager then keeps in close touch with patients to make this plan work. This plan includes regular telephone contact with patients, support to those who are taking medication and advice about psychological ways to improve depression. The case manager accesses regular advice from psychiatrists and psychologists and ensures that the patient?s GP is fully involved in the treatment plan.
Recently, three research groups in the UK have demonstrated that it may be possible to adapt these methods of working for the UK. These groups have now come together to plan a large clinical trial in the UK which will thoroughly test this new approach.
The research study will test collaborative care by allocating consenting patients to either collaborative care or to the care a patient would usually receive from their GP. We will carefully measure patients? symptoms of depression before the study and after four months to test if patients receiving collaborative care are more improved that those receiving usual care from their GP. We will also assess patients? symptoms again after 12 months. In addition, we will count the extent to which patients have used other health services and do an economic analysis to see if collaborative care is cost effective.
If, as we suspect, we are able to show that people receiving collaborative care improve more than people receiving usual care and that this is cost effective, we will ensure that collaborative care becomes the recommended way of supporting the treatment of people with depression in primary care.
Technical Summary
Background: depression causes substantial disability and is set to become the second largest cause of disease burden by 2020. Only one in four depressed people receive pharmacological treatment and less than 10% a talking therapy. ?Collaborative care? is a systems-level intervention to improve the treatment of depression in primary care. It has a strong American evidence base but there are no definitive UK trials. Having developed and pilot tested a UK collaborative care protocol using the MRC?s complex interventions framework, funded through the MRC?s Brain Sciences Trial Platform initiative, we are now at the point in which we can undertake a Phase III definitive trial.
Research Question: is collaborative care more clinically and cost effective than usual care in the management of moderate to severe depression in UK primary care?
Design: a multi-centre, two-arm cluster-randomised controlled trial of collaborative care compared to usual care for patients with moderate to severe depression.
Interventions: experimental - UK-specific collaborative care protocol developed from our Trial Platform delivered via scheduled telephone and face-to-face contacts by a supervised case manager over four months and including: 1) a multi-professional approach to patient care; 2) a structured patient management plan including medication support and/or CBT based behavioural activation; 3) scheduled patient follow-ups; 4) enhanced inter-professional communication. Control ? usual management by GPs to guidance in local protocols.
Participants: patients aged 18 years and above with moderate or severe depression in primary care.
Primary outcome: severity of depression at four and twelve months follow up.
Secondary outcomes: diagnosis of depression; health related quality of life; health care utilisation; health state utilities; satisfaction. The trial also includes a mixed quantitative and qualitative process evaluation
Sample size: 440 patients in total to detect an effect size of 0.4 at 90% power (alpha 0.05) with a design effect of 1.65. 550 patients will be randomised to anticipate a loss to follow up of 20%.
Analysis: between groups using analysis of covariance on individual baseline depression score, taking clustering into account by use of robust standard errors. Secondary outcome variables analysed in the same way, using least squares or ordered logistic regression as appropriate.
Economic analysis: the incremental cost per QALY of the intervention compared to the control will be calculated from NHS and PSS perspectives. Full sensitivity analyses will be conducted with bootstrapping to provide confidence intervals around cost and effect estimates and to produce cost acceptability curves.
Duration: four years
Research Question: is collaborative care more clinically and cost effective than usual care in the management of moderate to severe depression in UK primary care?
Design: a multi-centre, two-arm cluster-randomised controlled trial of collaborative care compared to usual care for patients with moderate to severe depression.
Interventions: experimental - UK-specific collaborative care protocol developed from our Trial Platform delivered via scheduled telephone and face-to-face contacts by a supervised case manager over four months and including: 1) a multi-professional approach to patient care; 2) a structured patient management plan including medication support and/or CBT based behavioural activation; 3) scheduled patient follow-ups; 4) enhanced inter-professional communication. Control ? usual management by GPs to guidance in local protocols.
Participants: patients aged 18 years and above with moderate or severe depression in primary care.
Primary outcome: severity of depression at four and twelve months follow up.
Secondary outcomes: diagnosis of depression; health related quality of life; health care utilisation; health state utilities; satisfaction. The trial also includes a mixed quantitative and qualitative process evaluation
Sample size: 440 patients in total to detect an effect size of 0.4 at 90% power (alpha 0.05) with a design effect of 1.65. 550 patients will be randomised to anticipate a loss to follow up of 20%.
Analysis: between groups using analysis of covariance on individual baseline depression score, taking clustering into account by use of robust standard errors. Secondary outcome variables analysed in the same way, using least squares or ordered logistic regression as appropriate.
Economic analysis: the incremental cost per QALY of the intervention compared to the control will be calculated from NHS and PSS perspectives. Full sensitivity analyses will be conducted with bootstrapping to provide confidence intervals around cost and effect estimates and to produce cost acceptability curves.
Duration: four years
