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      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

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          Abstract

          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.

          Related collections

          Most cited references29

          • Record: found
          • Abstract: found
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          Generalized anxiety disorder: prevalence, burden, and cost to society.

          Generalized anxiety disorder (GAD) is a prevalent and disabling disorder characterized by persistent worrying, anxiety symptoms, and tension. It is the most frequent anxiety disorder in primary care, being present in 22% of primary care patients who complain of anxiety problems. The high prevalence rate of GAD in primary care (8%) compared to that reported in the general population (12-month prevalence 1.9-5.1%) suggests that GAD patients are high users of primary care resources. GAD affects women more frequently than men and prevalence rates are high in midlife (prevalence in females over age 35: 10%) and older subjects but relatively low in adolescents. The natural course of GAD can be characterized as chronic with few complete remissions, a waxing and waning course of GAD symptoms, and the occurrence of substantial comorbidity particularly with depression. Patients with GAD demonstrate a considerable degree of impairment and disability, even in its pure form, uncomplicated by depression or other mental disorders. The degree of impairment is similar to that of cases with major depression. GAD comorbid with depression usually reveals considerably higher numbers of disability days in the past month than either condition in its pure form. As a result, GAD is associated with a significant economic burden owing to decreased work productivity and increased use of health care services, particularly primary health care. The appropriate use of psychological treatments and antidepressants may improve both anxiety and depression symptoms and may also play a role in preventing comorbid major depression in GAD thus reducing the burden on both the individual and society. Copyright 2002 Wiley-Liss, Inc.
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            THE REVISED COGNITIVE THERAPY SCALE (CTS-R): PSYCHOMETRIC PROPERTIES

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              • Article: not found

              Psychological treatment of generalized anxiety disorder: a meta-analysis.

              Recent years have seen a near-doubling of the number of studies examining the effects of psychotherapies for generalized anxiety disorder (GAD) in adults. The present article integrates this new evidence with the older literature through a quantitative meta-analysis. A total of 41 studies (with 2132 patients meeting diagnostic criteria for GAD) were identified through systematic searches in bibliographical databases, and were included in the meta-analysis. Most studies examined the effects of cognitive behavior therapy (CBT). The majority of studies used waiting lists as control condition. The pooled effect of the 38 comparisons (from 28 studies) of psychotherapy versus a control group was large (g=0.84; 95% CI: 0.71-0.97) with low to moderate heterogeneity. The effects based on self-report measures were somewhat lower than those based on clinician-rated instruments. The effects on depression were also large (g=0.71; 95% CI: 0.59-0.82). There were some indications for publication bias. The number of studies comparing CBT with other psychotherapies (e.g., applied relaxation) or pharmacotherapy was too small to draw conclusions about comparative effectiveness or the long-term effects. There were some indications that CBT was also effective at follow-up and that CBT was more effective than applied relaxation in the longer term. Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Health Technology Assessment
                Health Technol Assess
                National Institute for Health Research
                1366-5278
                2046-4924
                August 2017
                August 2017
                : 21
                : 45
                : 1-138
                Affiliations
                [1 ]Research Department of Primary Care and Population Health, University College London, London, UK
                [2 ]Department of Clinical Health Psychology, University College London, London, UK
                [3 ]Division of Psychiatry, University College London, London, UK
                [4 ]The Priory Hospital North London, The Bourne, London, UK
                [5 ]UCL Great Ormond Street Institute of Child Health, University College London, London, UK
                [6 ]McPin Foundation, London, UK
                [7 ]Centre for Mental Health, Imperial College London, London, UK
                Article
                10.3310/hta21450
                5592433
                28853392
                0158bef9-dc8e-4dca-acd7-a5e839e6f985
                © 2017

                Free to read

                http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/non-commercial-government-licence.htm

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