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      Protocol for a proof of concept randomized controlled trial of cognitive-behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone

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          Abstract

          Background

          ADHD is prevalent in adults and frequently associated with impairment and distress. While medication is often the first line of treatment a high proportion of people with the condition are not fully treated by medication alone, cannot tolerate medication or do not wish to take it. Preliminary studies suggest that psychosocial approaches are a promising adjunctive or alternative treatment option. To date, individual cognitive-behaviour therapy (CBT) has been found to be efficacious in three randomized controlled trials (RCTs). There is a need for more RCTs to be carried out in order to replicate these results in different sites, to further investigate the acceptability and feasibility of CBT in this population and to further develop CBT approaches based on a psychological model. This randomized controlled trial investigates the efficacy of individual, formulation-based CBT when added to treatment-as-usual as compared with treatment as usual alone.

          Methods/design

          Sixty patients with a diagnosis of adult ADHD attending a specialist clinic are randomly allocated to 1 of 2 treatments, ‘Treatment as Usual’ (TAU) or TAU plus 16 sessions individual CBT (TAU + CBT). In the TAU + CBT, the first 15 sessions take place over 30 weeks with a 16th ‘follow-up’ session at 42 weeks. Outcomes are assessed at 30 weeks and 42 weeks following randomization. The two primary outcomes are self-rated ADHD symptoms and functioning (occupational and social). Secondary outcomes include distress, mood, ADHD-related cognitions, ADHD-related behaviours and informant-rated ADHD symptoms.

          The primary analysis will include all participants for whom data is available and will use longitudinal regression models to compare treatments. Secondary outcomes will be analysed similarly.

          Discussion

          The results of the study will provide information about a) whether CBT adds benefit over and above TAU for ADHD and, b) if CBT is found to be efficacious, potential mechanisms of change and predictors of efficacy.

          Trial registration

          Current Controlled Trials ISRCTN03732556, assigned 04/11/2010

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          Most cited references 56

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          The Hospital Anxiety and Depression Scale

           A Zigmond,  R P Snaith (1983)
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            The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10.

            The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-IV and ICD-10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings. The authors describe the development of the M.I.N.I. and its family of interviews: the M.I.N.I.-Screen, the M.I.N.I.-Plus, and the M.I.N.I.-Kid. They report on validation of the M.I.N.I. in relation to the Structured Clinical Interview for DSM-III-R, Patient Version, the Composite International Diagnostic Interview, and expert professional opinion, and they comment on potential applications for this interview.
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              Society and the Adolescent Self-Image

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                Author and article information

                Contributors
                antonia.dittner@slam.nhs.uk
                Katharine.rimes@kcl.ac.uk
                a.j.russell@bath.ac.uk
                Trudie.chalder@kcl.ac.uk
                Journal
                BMC Psychiatry
                BMC Psychiatry
                BMC Psychiatry
                BioMed Central (London )
                1471-244X
                3 September 2014
                3 September 2014
                2014
                : 14
                : 1
                Affiliations
                [ ]King’s College London, King’s Health Partners, Behavioural and Developmental Psychiatry Clinical Academic Group, Maudsley Adult ADHD Service, South London and Maudsley NHS Foundation Trust, London, UK
                [ ]King’s College London, King’s Health Partners, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, London, UK
                [ ]King’s College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, London, UK and Department of Psychology, University of Bath, Bath, UK
                [ ]King’s College London, King’s Health Partners, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, London, UK
                Article
                248
                10.1186/s12888-014-0248-1
                4158100
                © Dittner et al.; licensee BioMed Central Ltd. 2014

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Study Protocol
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                © The Author(s) 2014

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