Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial

Tyrer, Peter; Cooper, Sylvia; Šalkovskis, Paul M.; Tyrer, Helen; Crawford, Mike; Byford, Sarah; Dupont, Simon; Finnis, Sarah; Green, John; McLaren, Elenor; Murphy, David; Reid, Steven; Smith, Georgina; Wang, Duolao; Warwick, Hilary M. C.; Petkova, Hristina; Barrett, Barbara

doi:10.1016/s0140-6736(13)61905-4

Cited by 135 publications

(149 citation statements)

References 26 publications

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“…Pharmacological treatment is not normally acceptable to patients, as those with marked health anxiety are typically very sensitive to adverse effects of medication: but fluoxetine showed some benefit over placebo, though this was not pronounced and occurred late in treatment (8-12 weeks [I (PCT)] (Fallon et al, 2008). Psychological treatments have been found beneficial [I (M)] ( Thomson and Page, 2007), and include behavioural stress management (Clark et al, 1998) ([II]), cognitive behaviour therapy, in both face-to-face and internet format (Hedman et al, 2011b;Seivewright et al, 2008;Sørensen et al, 2011) (Tyrer et al, 2014).…”

Section: Marked Health Anxiety ('Illness Anxiety Disorder')mentioning

confidence: 99%

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

et al. 2014

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This revision of the 2005 British Association for Psychopharmacology guidelines for the evidence-based pharmacological treatment of anxiety disorders provides an update on key steps in diagnosis and clinical management, including recognition, acute treatment, longer-term treatment, combination treatment, and further approaches for patients who have not responded to first-line interventions. A consensus meeting involving international experts in anxiety disorders reviewed the main subject areas and considered the strength of supporting evidence and its clinical implications. The guidelines are based on available evidence, were constructed after extensive feedback from participants, and are presented as recommendations to aid clinical decision-making in primary, secondary and tertiary medical care. They may also serve as a source of information for patients, their carers, and medicines management and formulary committees.

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Section: Marked Health Anxiety ('Illness Anxiety Disorder')mentioning

confidence: 99%

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

et al. 2014

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“…Tests and confidence intervals for treatment effects would be based on the normal distribution -an assumption justified by the central limit theorem. Estimates for the standard deviation (SD) of HADS-A scores are available from Tyrer et al 50 In this study, SDs between 4 and 5 were found for the change of score between baseline and 12 months for both randomised conditions. Therefore, we used an estimate of 5 for the SD of our outcome measure, overlaid with an additional component of variance (essentially attributable to the therapist) sufficient to give an intracluster correlation coefficient of 0.02.…”

Section: Sample Size Calculationmentioning

confidence: 57%

“…Exploratory analyses would have been carried out to describe how patient preferences along with a limited number of other prespecified characteristics of participants may modify treatment effects. 50 Any subgroup analyses conducted would also have been regarded as exploratory.…”

Section: Primary Outcome Analysismentioning

confidence: 99%

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines

Buszewicz

Cape

Serfaty

et al. 2017

Health Technol Assess

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Background Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. Objectives To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. Design Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. Setting Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. Participants People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. Inclusion criteria Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. Exclusion criteria Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing greater distress than GAD, significant dependence on alcohol or illicit drugs, comorbid psychotic disorder, received antidepressants in past 8 weeks or high-intensity psychological therapy in previous 6 months and any contraindications to treatment with sertraline. Randomisation Consenting eligible participants randomised via an independent, web-based, computerised system. Interventions (1) The SSRI sertraline prescribed in therapeutic doses by the patient’s general practitioner for 12 months and (2) 14 (± 2) CBT sessions delivered by high-intensity IAPT psychological therapists in accordance with a standardised manual designed for GAD. Main outcome measures The primary outcome was the Hospital Anxiety and Depression Scale – Anxiety component at 12 months. Secondary outcomes included measures of depression, social functioning, comorbid anxiety disorders, patient satisfaction and economic evaluation, collected by postal self-completion questionnaires. Results Only seven internal pilot participants were recruited against a target of 40 participants at 7 months. Far fewer potential participants were identified than anticipated from IAPT services, probably because PWPs rarely considered GAD the main treatment priority. Of those identified, three-quarters declined participation; the majority (30/45) were reluctant to consider the possibility of randomisation to medication. Limitations Poor recruitment was the main limiting factor, and the trial closed prematurely. Conclusions It is unclear how much of the recruitment difficulty was a result of conducting the trial within a psychological therapy service and how much was possibly a result of difficulty identifying participants with primary GAD. Future work It may be easier to answer this important question by recruiting people from primary care rather than from those already engaged in a psychological treatment service. Trial registration Current Controlled Trials ISCRTN14845583. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 45. See the NIHR Journals Library website for further project information.

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“…71 CBT treatment for health anxiety was effective at 6 months, 1 and 2 years with no significant increase in costs for anxiety and depression, but was ineffective in increasing health-related QoL. 72 We are unsure what the difference is between the therapies that continue to be efficacious for affective symptoms and those that do not, but our intervention adds to the evidence that therapies can continue to be effective over years.…”

Section: Structured Psychological Treatment Of Depression In Other Grmentioning

confidence: 88%

START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia

Livingston

Barber

Rapaport

et al. 2014

Health Technology Assessment

163

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BackgroundTwo-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions.ObjectivesTo assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU).DesignRandomised, parallel-group, superiority trial with blinded assessment recruiting participants 2 : 1 (intervention to TAU) to allow for therapist clustering.SettingThree UK mental health services and one neurological service.ParticipantsFamily carers of people with dementia.InterventionEight-session manual-based coping intervention delivered by supervised psychology graduates to individuals.Main outcome measuresAffective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission.ResultsTwo hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU).In the short term, the intervention group had lower HADS-T [mean difference –1.80, 95% confidence interval (CI) –3.29 to –0.31;p = 0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI –0.01 to 0.08). Costs were no different between groups [mean £252 (95% CI –£28 to £565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (–0.91, 95% CI –1.76 to –0.07;p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (–0.91, 95% CI –1.71 to –0.10;p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia’s quality of life-Alzheimer’s disease (QoL-AD) (mean increase 0.59, 95% CI –0.72 to 1.89) were not significant.In the long term, the intervention group had lower HADS-T (mean difference –2.58, 95% CI –4.26 to –0.90;p = 0.03) and higher QALYs (mean difference 0.03, 95% CI –0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (–1.16, 95% CI –2.15 to –0.18) and HADS-D (1.45, 95% CI –2.32 to –0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56;p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia’s QoL-AD (0.17, 95% CI –1.37 to 1.70) or costs (£336, 95% CI –£223 to £895) for intervention group. The probability that the intervention would be seen as cost-effective at £30,000/QALY threshold and cost-effectiveness on the HADS-T remained high.ConclusionsThe START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient’s care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice.Trial registrationCurrent Controlled Trials ISCTRN70017938.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial

Abstract: National Institute for Health Research Health Technology Assessment Programme.

Cited by 135 publications

References 26 publications

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia

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