Professor John Cape and Dr Marta Buszewicz (left) outline the updated NICE recommendations on the identification, assessment, and treatment of generalised anxiety disorder


Over the past 10 years or so there has been considerable emphasis on encouraging GPs to improve their skills in the diagnosis and management of depression. In contrast, anxiety disorders, which are associated with significant disability, have been relatively neglected and there is evidence that they are both common and often inadequately treated. 1

Generalised anxiety disorder (GAD) is one of the commonest mental health disorders. It affects 4.4% of the adult population and is the most prevalent mental health disorder after mixed anxiety and depressive disorder as shown by the 1993, 2000, and 2007 surveys on Adult psychiatric morbidity in England.2 Generalised anxiety disorder is characterised by worry and tension—worries are typically wide-ranging, involve everyday issues and a shifting focus of concern, and are difficult to control.3,4 Like other anxiety disorders, GAD is often chronic if untreated,3,5 and is associated with substantial disability in terms of diminished functioning both socially and at work, equivalent to chronic physical health problems such as arthritis and diabetes.5 People with GAD have frequent contact with primary and secondary care, both because of the associated somatic symptoms and worries, and because the disorder is often co-morbid with chronic physical health problems.6–8

In January 2011, NICE issued a partial update of the guideline on anxiety disorder and panic disorder originally published in December 2004. The new guideline (Clinical Guideline [CG] 113) on Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults: management in primary, secondary and community care9 only updates the management of GAD; evidence and recommendations on panic disorder were not reviewed. Only GAD was appraised because of its relatively high prevalence and also the developments in evidence regarding its treatment, particularly medication. Key aspects of the updated guideline are:9

  • a new stepped-care model for management of GAD, which parallels that in the NICE guideline on depression10
  • the increased role for low-intensity psychological interventions
  • the revised recommendations regarding pharmacological treatment.

Other anxiety disorders for which there are NICE guidelines are post-traumatic stress disorder and obsessive compulsive disorder.11,12 A guideline on social phobia is in the planning stage.

Identification and assessment

Generalised anxiety disorder, in common with other anxiety disorders, is underrecognised in primary care.13,14 This is partly because, when people with GAD come to GPs, they tend to present the physical or somatic symptoms and may be wrongly investigated and treated for these.15 Even if the GP recognises that the patient has ‘anxiety’, the specific characteristics of GAD, with its multiple, uncontrollable worries about all types of events and circumstances, may not be identified and the diagnosis missed.

Clinical Guideline 113 recommends considering GAD in the following patient groups:9

  • Patients presenting directly with anxiety or worry
  • Those with chronic physical health problems (as these have a high co-morbidity with GAD)
  • Patients repeatedly seeking reassurance about somatic symptoms
  • Patients who are repeatedly worrying about a wide range of different issues.

Patients in these groups should be asked about the worries they experience. Key questions are:

  • Do you worry about a whole range of different things or happenings in your life?
  • Do you feel unable to control your worry?

The focus of the worry should not be confined to the specific features of one of the other anxiety disorders (i.e. the worry should not just be about having a panic attack [panic disorder], social embarrassment [social phobia], a traumatic event [post-traumatic stress disorder], being contaminated [obsessive compulsive disorder], or having a serious illness [hypochondriasis]).

Although GAD needs to be distinguished from other anxiety disorders, it also commonly co-exists with other anxiety disorders and with depressive disorders.4,16–19 Pure GAD, in the absence of another anxiety or depressive disorder, is less typical than co-morbid GAD. The latter raises the question of which guideline to use when a patient has another anxiety or depressive disorder in addition to GAD. The NICE guideline on GAD recommends treating the primary disorder first (i.e. the one that is most severe and where it is more likely that treatment will improve overall functioning).9 There is a similar recommendation in the updated NICE guideline on depression.10 This is different from earlier versions of these guidelines, which recommended always treating depression first. Both guidelines now recommend that the clinician makes a judgement as to whether treating the anxiety disorder or the depression first is more likely to improve overall functioning.9,10

People with GAD, particularly men, frequently have problems with substance misuse.17,19 The updated guideline notes that non-harmful substance misuse should not be a contraindication to treatment of GAD, but recommends that harmful and dependent substance misuse should be treated first as this may lead to significant improvement in GAD symptoms.9

Figure 1: Stepped-care model for generalised anxiety disorder9

graph

*A self-administered intervention intended to treat GAD involving written or electronic self-help materials (usually a book or workbook). It is similar to individual guided self-help but usually with minimal therapist contact, for example an occasional short telephone call of no more than 5 minutes.

GAD=generalised anxiety disorder

National Institute for Health and Care Excellence. Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults: management in primary, secondary and community care. Clinical Guideline 113. London: NICE, 2011. Reproduced with kind permission. Available at: nice.org.uk/CG113

Stepped-care model

The NICE guideline sets out a revised stepped-care model for selecting appropriate interventions for GAD (see Figure 1), which parallels the steps in the NICE guideline on depression10 and is different from the model in the original anxiety guideline. People with GAD should be offered the least intrusive, most effective intervention first. For the majority of people who do not improve with initial education about GAD and active GP monitoring, this would be a low-intensity psychological intervention, stepping up to a high-intensity psychological intervention or drug treatment if there is no improvement. However, where a patient has GAD that markedly impairs day-to-day functioning, the guideline recommends bypassing the low-intensity step and starting directly with a high-intensity psychological intervention or drug treatment.9

General practitioners have roles at all steps of the model as shown in Table 1 (see below).

Table 1: GP roles in stepped-care model for generalised anxiety disorder
Focus of intervention/process GP role
Step 1
Identification

Check for the presence of GAD in patients:

  • presenting directly with anxiety or worry
  • with chronic physical health problems (due to high co-morbidity with GAD)
  • repeatedly seeking reassurance about somatic symptoms
  • who are repeatedly worrying about a wide range of different issues

Ask about the worries the patient experiences:

  • Do you worry about a range of different things or happenings in your life?
  • Do you feel unable to control your worry?
Assessment
Ask about the degree of distress and functional impairment, any co-morbid mental health disorder and its severity, any co-morbid medical condition, substance misuse, and past response to treatment for anxiety if applicable
Education and active monitoring

Education and active monitoring is an active process of assessment, information giving, advice, and support, which characterises effective interventions for people with mild GAD that may spontaneously remit. This process may include:

  • exploring presenting problems and concerns
  • provision of information about the nature and course of GAD
  • offering follow up in around 2 weeks
  • making contact if the patient does not attend follow-up appointments
Step 2
Provision of self-help materials
  • Provide self-help materials about GAD based on CBT (check the local IAPT or other service that provides CBT for recommendations regarding suitable materials)
  • Offer follow up in around 4 weeks
Referral to low-intensity psychological interventions
  • Have knowledge of the low-intensity psychological interventions recommended in the NICE guideline and where they are available locally
  • Explain to the patient what low-intensity interventions entail
  • Continue to review and support the patient
Step 3
Referral to high-intensity psychological interventions
  • Check patient's views as to whether they would prefer a psychological intervention (CBT) or a pharmacological treatment at Step 3
  • Be aware of the local services providing CBT and referral pathways
  • Continue to review and support the patient
Pharmacological treatment

Explore patient's views about pharmacological treatment:

  • Prescribe an SSRI first; consider offering sertraline
  • Give information about possible side-effects, including discontinuation symptoms
  • Do not prescribe a benzodiazepine for GAD except as a short-term measure in crisis
  • Do not prescribe an antipsychotic for GAD
Switching treatments when no response
  • If no response to CBT, offer an SSRI
  • If partial response to an SSRI, offer referral for CBT
  • If no response to an SSRI, offer referral to CBT or switch to an SNRI
  • If the patient cannot tolerate an SSRI or SNRI and wants pharmacological treatment, offer pregabalin
Step 4
Referral for specialist treatment
Have knowledge of local services providing specialist treatment for GAD with marked functional impairment that does not respond to all Step 3 treatments.

GAD=generalised anxiety disorder; CBT=cognitive behavioural therapy; IAPT=improving access to psychological therapies; SSRI=selective serotonin reuptake inhibitor; SNRI=serotonin noradrenaline reuptake inhibitor

 


Low-intensity psychological interventions

The guideline recommends low-intensity psychological interventions as the first-line treatment step for patients who do not improve with active GP monitoring or want some intervention immediately following diagnosis. These are:9

  • individual non-facilitated self-help
  • individual guided self-help
  • psycho-educational groups.

Individual non-facilitated and guided self-help can be provided by GPs if they have access to appropriate materials to offer patients, but these could also be provided by a:

  • local service such as an improving access to psychological therapies (IAPT) service20
  • third-sector service (provided by the voluntary sector but commissioned by local NHS commissioners)
  • primary care mental health team.

The GP needs to explain what the low-intensity intervention might entail and to find out whether their patient would find this acceptable. Therefore, even if they do not provide such low-intensity interventions themselves, GPs require a working knowledge of them as recommended by the NICE guideline. The evidence for benefit is similar for all three recommended low-intensity psychological interventions, so it is suggested that the choice should depend on patient preference and availability.

Both non-facilitated and guided self-help involve giving the patient written, audio-recorded, or computerised self-help materials based on cognitive behavioural therapy (CBT) principles. The difference between non-facilitated (sometimes called pure self-help) and guided self-help, is that the former involves no or minimal contact with a healthcare professional, while guided self-help involves up to six or seven short meetings with a healthcare professional to facilitate the patient making best use of the materials. A GP was the facilitator in two of the trials included in the evidence for guided self-help that was reviewed by NICE.21,22

Interestingly, the guideline on GAD differs from the one on depression in the recommendations on non-facilitated self-help. While the latter only recommends guided self-help because non-facilitated self-help does not appear to be effective in depression,10 non-facilitated self-help does appear to be effective for GAD and is recommended for this level of a stepped-care approach.9 It is uncertain why this difference exists, but it may be difficult for people with significant depression to motivate themselves to use self-help materials on their own.

Psycho-educational groups use a didactic approach, focusing on educating participants about the nature of anxiety and ways of managing their condition using CBT techniques. They are more similar in format to an evening class than a therapeutic group and can have from 6–24 participants, often with more than one leader. ‘Classes’ are usually delivered weekly for 2 hours over a 6-week period and include presentations and self-help materials.9

High-intensity psychological interventions

The high-intensity psychological therapies recommended for treatment of GAD are CBT, as in the original guideline, or applied relaxation.9 The latter involves teaching relaxation skills and training the patient with GAD to use these skills during exposure to anxiety provoking situations. This training is critical and distinguishes applied relaxation from other forms of relaxation training/practice without this applied component.

Applied relaxation follows a clear protocol: it takes place over 12–15 sessions of treatment and should be carried out by practitioners trained in CBT as well as applied relaxation. The recommended length of treatment (12–15 sessions) and training requirement for practitioners of applied relaxation and CBT are similar in the NICE guideline.9

Pharmacological treatment

In the stepped-care model, pharmacological treatments for GAD are at step 3. Generally, this means that patients should have tried a low-intensity psychological intervention before being offered medication. There are, however, exceptions, such as a level of GAD that markedly impairs day-to-day functioning or a patient refusing low-intensity interventions. In such cases bypassing step 2 and starting with medication would be appropriate.9

There are several changes in the recommendations from the previous anxiety guideline with regard to medication use. As previously, a selective serotonin reuptake inhibitor (SSRI) is recommended as first-line, but it is now suggested that sertraline be considered initially because it is the most cost-effective drug. An alternative SSRI or a serotonin noradrenaline reuptake inhibitor (SNRI) is a second-line option. Sedative antihistamines are no longer recommended, but pregabalin can be considered if an SSRI or SNRI cannot be tolerated.9

NICE rarely recommends drugs ‘off licence’, except in children where many are not licensed. In CG 113, sertraline emerged as clearly the most cost-effective drug for GAD when compared with other drugs licensed for this use.9 The use of sertraline in this context is acceptable, but should be accompanied with advice on both the evidence for its use and the fact that there is currently no marketing authorisation for this indication.

Treatment-refractory GAD

The guideline recommends trying alternative step 3 therapy if a person has not improved with an initial step 3 treatment. For example, if they have not improved with a full course of a high-intensity psychological intervention, a pharmacological treatment should be offered. Alternatively, if their GAD has not responded to drug treatment, then a different drug treatment or a high-intensity psychological intervention (CBT or applied relaxation) should be offered. If there has been a partial response to drug treatment, it is suggested that a high-intensity psychological intervention is offered alongside medication.9 If the patient has not improved following different step 3 treatments and has marked functional impairment, stepping them up to specialist treatment (i.e. step 4) is recommended. This may be in primary or secondary care, depending on how services are configured locally. In principle, a GP with a Special Interest in Mental Health could take on this role for a practice or network of practices, but in most cases it is likely to involve referral to a community mental health team or a highly specialist psychological therapy service.9

Implementation

Limited access nationally to CBT and to the range of recommended low-intensity psychological interventions based on CBT was a major barrier to implementation of the original 2004 guideline. Since the IAPT national initiative,20 this will have substantially improved in many areas and should further improve with the October 2010 Spending Review announcement of continued national investment and roll-out of the IAPT programme.23 However, this depends on effective commissioning, without which service provision may remain variable between different parts of the country.

Summary

The 2011 updated guideline sets out a revised stepped-care model of appropriate interventions for GAD. This parallels the NICE guideline on depression and should simplify commissioning decisions and GP clinical choices, as the same organisations generally provide services for both anxiety disorders and depression.

The updated guideline emphasises the importance of low-intensity psychological interventions as the first treatment step for GAD and for many people these brief interventions supporting self-management will be all that they want or need. Patients with marked functional impairment, or those who do not improve with low-intensity psychological interventions, will need CBT or pharmacological treatment and the guideline adds to the evidence for these interventions, with some revised recommendations regarding pharmacological therapies.

Acknowledgments

This paper is based on the work of the Guideline Development Group for the anxiety update of which John Cape and Marta Buszewicz were members.

The views expressed in the paper are those of the authors and not necessarily those of the National Collaborating Centre for Mental Health responsible for development of the guideline, or of NICE.

Implementation tools

NICE has developed the following tools to support implementation of Clinical Guideline 113 on Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults: management in primary, secondary and community care. The tools are now available to download from the NICE website: www.nice.org.uk/CG113

Audit support

Audit support has been developed to support the implementation of this guideline. The aim is to help NHS organisations with a baseline assessment and to assist with the audit process, thereby helping to ensure that practice is in line with the NICE recommendations. The audit support is based on the key recommendations of the guidance and includes criteria and data collection tools.

Baseline assessment tool

The baseline assessment tool is an Excel spreadsheet that can be used by organisations to identify if they are in line with practice recommended in NICE guidance and to help them plan activity that will help them meet the recommendations.

Costing tools

A costing statement and local costing template for the guideline have been produced:

  • The costing statement estimates the financial impact to the NHS of implementing this clinical guideline. This statement focuses on the financial impact of the recommendations that require most change in resources to implement in England
  • Costing templates are spreadsheets that allow individual NHS organisations and local health economies to estimate the costs of implementation taking into account local variation from the national estimates, and they can quickly assess the impact the guideline may have on local budgets.

Slide set

The slides provide a framework for discussing the NICE guideline with a variety of audiences and can assist in local dissemination. This information does not supersede or replace the guidance itself.

  • Effective treatment of GAD can help provide savings against commissioning budgets by reducing inappropriate referrals for investigation of physical symptoms associated with anxiety
  • NICE recommends low-intensity psychological therapies as first-line treatment for GAD before initiating drug treatment
  • GP commissioners should ensure that these therapies are freely available in primary care through the IAPT program or a similar service
  • GP commissioners should ensure GPs are aware of and understand the three types of low-intensity interventions to help guide patient choice
  • Effective pharmacological treatments such as sertraline and most other SSRIs are now available at low acquisition cost, and local formularies should promote the use of these therapies
  • These formularies should indicate where and when more expensive agents such as SNRIs or pregabalin are to be used to help rationalise costs.
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