Guidance

Recommendations for research

Recommendations for research

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

1 Combined medication and CBT for patients with moderate to severe depression and a chronic physical health problem

What is the clinical and cost effectiveness of combined medication and cognitive behavioural therapy (CBT) compared with antidepressants or CBT alone for patients with moderate to severe depression and a chronic physical health problem?

Why this is important

There is limited evidence for the effectiveness of combined antidepressant treatment and CBT for patients with moderate to severe depression and a chronic physical health problem. Data from studies in patients with depression in the absence of a chronic physical health problem suggest that combined treatment may bring real benefit. However, uncertainty about medium-term outcomes for these patients remains. In addition to uncertainty about the effectiveness of the interventions, the potential for interactions between medication prescribed for depression and for chronic physical health problems is a concern. This needs to be considered in terms of both the difficulties that may arise from drug interactions and the anxieties of individual patients about this, which may reduce the likelihood of them complying with antidepressant medication. The answer to this question has practical implications for service delivery and resource allocation in the NHS.

The outcomes for this proposed study should involve both observer-rated and patient-rated assessments of acute and medium-term outcomes for at least 6 months and an assessment of the acceptability and potential burden of the various treatment options. The study should be large enough to determine the presence or absence of any clinically important effects using a non-inferiority design together with robust health economic measures.

2 Peer support interventions compared with group-based exercise and treatment as usual for patients with mild to moderate depression and a chronic physical health problem

What is the clinical and cost effectiveness of group peer support and group-based exercise when compared with treatment as usual for patients with mild to moderate depression and a chronic physical health problem?

Why this is important

There is limited evidence for the effectiveness of peer support and exercise in the treatment of patients with depression and a chronic physical health problem. Although the available data suggest that both are practical and potentially acceptable treatments that may bring real benefit, uncertainty remains about medium-term outcomes. The answer to this question has practical implications for service delivery and resource allocation in the NHS.

This question should be answered in an adequately powered 3‑arm randomised controlled trial that examines medium-term outcomes, including cost effectiveness. The outcomes should reflect both observer-rated and patient-rated assessments for acute and medium-term outcomes for 12 months, and an assessment of the acceptability and potential burden of treatment options. The study should be large enough to determine the presence or absence of clinically important effects using a non-inferiority design with robust health economic measures.

3 Antidepressant medication compared with placebo in patients with depression and COPD

What is the clinical and cost effectiveness of antidepressant medication compared with placebo in patients with depression and chronic obstructive pulmonary disease (COPD)?

Why this is important

There is limited evidence for the effectiveness of antidepressant treatment in patients with depression and a chronic physical health problem. Of particular concern to the Guideline Development Group was the high incidence of depression in patients with COPD (which is also known to be associated with a high incidence of anxiety disorders). The Guideline Development Group considered it important to measure the effectiveness of antidepressant medication in the treatment of COPD. The answer to this question has important practical implications for service delivery, particularly for a patient group with mental health needs that are traditionally under-treated within the NHS.

The question should be answered using a randomised controlled trial in which patients with moderate depression and COPD receive either placebo or antidepressant medication. The outcomes chosen should reflect both observer-rated and patient-rated assessments for acute and medium-term outcomes for at least 6 months and an assessment of the acceptability and burden of treatment. In addition to the assessment of symptoms of depression, the study should also assess the impact of antidepressant medication on symptoms of anxiety. The study should be large enough to determine the presence or absence of clinically important effects using a non-inferiority design together with robust health economic measures.

4 Behavioural activation compared with antidepressant medication for patients with moderate to severe depression and a chronic physical health problem

What is the clinical and cost effectiveness of behavioural activation compared with antidepressant medication in the treatment of moderate to severe depression in patients with a chronic physical health problem?

Why this is important

There is limited evidence for the effectiveness of high-intensity psychological interventions in the treatment of moderate to severe depression in patients with a chronic physical health problem; the most substantial evidence base is for CBT. Recent developments suggest that behavioural activation may be an effective intervention for depression. In principle, this may be a more feasible treatment to deliver in routine care than CBT and could potentially contribute to increased treatment choice for patients. The answer to this question would have practical implications for service delivery and resource allocation within the NHS.

This question should be answered using a randomised controlled trial in which patients with moderate to severe depression and a chronic physical health problem receive either behavioural activation or antidepressant medication. The outcomes should be chosen to reflect both observer-rated and patient-rated assessments for acute and medium-term outcomes for at least 12 months and also assessment of the acceptability and burden of the treatment options. The study needs to be large enough to determine the presence or absence of clinically important effects using a non-inferiority design and robust health economic measures.

5 The effects of collaborative care on physical health outcomes for patients with moderate to severe depression and a chronic physical health problem

What is the clinical and cost effectiveness of collaborative care with regard to physical health outcomes for people with moderate to severe depression and a chronic physical health problem?

Why this is important

There is a reasonable evidence base to support the use of collaborative care in people with moderate to severe depression and a chronic physical health problem. However, the evidence base regarding the effects of collaborative care on physical health outcomes is more limited. Improved depression care is thought to produce other health benefits, such as improved functioning and physical outcomes; this may be particularly significant for people with depression and a chronic physical health problem. This means that interventions that also improve physical health should result in substantial increases in utility and subsequently result in quality-adjusted life year (QALY) gains. Furthermore, the ability to achieve such health gains can potentially reduce the population burden of illness and morbidity within healthcare budgets. There is an association between depression and increased use of medical services, and so it follows that improved treatment of depression could reduce medical expenditure, partially or fully offsetting the costs of treating the depression. The answer to this question has important practical implications for service delivery and resource allocation within the NHS.

This question should be answered using a randomised controlled trial design that includes people with moderate to severe depression and a chronic physical health problem. In addition to depression-related outcomes, physical health outcomes such as general physical functioning and pain, as well as outcomes specifically related to the condition (such as HbA1c for diabetes), should be assessed. These outcomes should reflect both observer-rated and patient-rated assessments of medium-term and long-term outcomes for at least 18 months. The study should also include an assessment of the acceptability and burden of treatment options and the impact of the intervention on the overall care system. It should be large enough to determine the presence or absence of clinically important effects using a non-inferiority design together with robust health outcome measures.

6 The effectiveness of physical rehabilitation programmes for patients with a chronic physical health problem and depression

What is the effectiveness of rehabilitation programmes for patients with depression and a chronic physical health problem in terms of improved mood?

Why this is important

Many patients with a chronic physical health problem undergo rehabilitation programmes. There is some suggestion in the literature that these have a beneficial effect on mental health. Understanding and/or enhancing the psychological benefits of these interventions has potentially important cost and service-design implications for the NHS. Given the large data set that already exists, it is important to determine the potential effects of these programmes to date before embarking on any individual studies. The answer to this question has important practical implications for service delivery and resource allocation within the NHS.

This question should be answered by an individual patient meta-analysis. There is an existing evidence base showing that programmes specifically designed to treat depression (for example, psychosocial and pharmacological interventions in patients with a chronic physical health problem) are effective. However, many patients with a chronic physical health problem are also undertaking specifically designed rehabilitation programmes (for example, cardiac rehabilitation programmes after myocardial infarction). These interventions are multi-modal and reports indicate that they can have an impact on mental health outcomes, in particular depression. However, it is unclear what the size of this effect may be, which components of the intervention are effective and which specific patient populations may benefit. Therefore an individual patient meta-analysis to examine the impact of rehabilitation programmes on symptoms of depression in patients with a chronic physical health problem should be undertaken before any further research is conducted.

7 The efficacy of counselling compared with low-intensity cognitive and behavioural interventions and treatment as usual in the treatment of depression in patients with a chronic physical health problem

What is the relative efficacy of counselling compared with low-intensity cognitive and behavioural interventions and treatment as usual in patients with depression and a chronic physical health problem?

Why this is important

There is a limited evidence base for counselling compared with treatment as usual in the treatment of patients with depression and a chronic physical health problem. High-intensity cognitive and behavioural interventions have the best evidence base for efficacy but there is limited evidence on the efficacy of low-intensity cognitive and behavioural interventions in patients with depression and a chronic physical health problem. The evidence on low-intensity cognitive and behavioural interventions for this guideline was largely supplemented by the evidence base in the NICE guideline on depression in adults. It is therefore important to establish whether either counselling or low-intensity cognitive and behavioural interventions are effective alternatives to treatment as usual for patients with a chronic physical health problem and should be provided in the NHS. The answer to this question will have important implications for the provision of psychological treatment in the NHS.

This question should be answered using a randomised controlled trial design that reports short-term and medium-term outcomes (including cost-effectiveness outcomes) of at least 18 months' duration. Particular attention should be paid to the reproducibility of the treatment model and the training and supervision of the practitioners providing interventions in order to ensure that the treatments are both robust and generalisable. The outcomes chosen should reflect both observer-rated and patient-rated assessments of improvement and an assessment of the acceptability of the treatment options. Particular attention should be given to physical health and quality-of-life outcomes in addition to depression outcomes. The study needs to be large enough to determine the presence or absence of clinically important effects using a non-inferiority design, and mediators and moderators of response should be investigated.