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ISRCTN
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ISRCTN97185214
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ClinicalTrials.gov identifier
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Public title
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Staying Well After Depression: a randomised trial
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Scientific title
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Modifying risk and severity of relapse in patients with recurrent depression at high suicide risk: translational randomised controlled trial
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Acronym
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SWAD
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Serial number at source
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Protocol version 5 (6/5/09); 067797
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Study hypothesis
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That treatment with mindfulness-based cognitive therapy for depression, a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, delivered in addition to treatment as usual (TAU), will:
1. Reduce risk of relapse to major depression in recurrently depressed patients compared with TAU alone and cognitive psycho-education (CPE), a treatment of equal plausibility, and
2. Reduce incidence of suicidal symptoms in those with a history of suicidality compared with TAU alone
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Lay summary
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Ethics approval
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Oxfordshire Research Ethics Committee (REC) C approved on the 27th June 2008 (ref: 08/H606/56)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Recurrent depression
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Participants - inclusion criteria
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1. Aged 18 years or over, and not older than 70 years due to the fact that depression in old age has often been found to be related to different factors than depression in earlier stages of life. Male or female.
2. Meeting enhanced Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a history of recurrent major depression, i.e. history of at least three episodes of depression, two of which must have occurred within the last five years, of which one must have occurred within the last two years. Although previous suicidality is recorded in detail (which allows stratification to be carried out on this basis) participants are not included/excluded from the study on the basis of their prior experience of suicidality.
3. Meeting the National Institute of Mental Health (NIMH) guidelines for recovery or remission at the time of baseline assessment. For the purposes of the trial participants are NOT deemed to be in recovery or remission (and hence are ineligible) if they report a week (or more) during the previous 8 weeks during which they experienced EITHER a core symptom of depression (depressed mood, anhedonia) or suicidal feelings AND at least one other symptom of depression, which together are not accounted for by bereavement or substances/general medical conditions, and which are accompanied by significant impairment in functioning.
4. Giving informed consent
5. Consent received from the participant's General Practitioner
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Participants - exclusion criteria
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Participants are excluded from the study if one or more of the following apply:
1. They have a history of schizophrenia, schizoaffective disorder, bipolar I disorder, current and severe substance abuse, organic mental disorder, pervasive developmental delay, a primary diagnosis of obsessive-compulsive disorder or eating disorder, or are currently regularly self-harming
2. They are showing a positive and continuing response to CBT
3. They have current psychotherapy or counseling more frequently than once per month
4. They are unable to complete the baseline research assessment (e.g. due to difficulties with English, visual impairment, or cognitive difficulties)
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Anticipated start date
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01/10/2008
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Can be found at http://www.staying-well.org/information-sheet (Oxford) and http://stayingwell.bangor.ac.uk/participant_info.php.en?menu=1&catid=7164&subid=0 (Bangor)
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Target number of participants
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300 after allowing for attrition
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Interventions
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Mindfulness-based cognitive therapy and cognitive psychoeducation as compared to ordinary care (treatment-as-usual).
Treatment duration: 8 weeks
Follow-up duration: 12 months
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Primary outcome measure(s)
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Time to relapse or recurrence meeting DSM-IV criteria for major depression, assessed using the Structured Clinical Interview for DSM-IV (SCID). Occurrence of relapse/recurrence is assessed at all follow-up assessments, and ‘return to treatment’ will be treated as a relapse/recurrence if, in the judgment of a blind assessor, the participant has experienced exacerbation of symptoms that would have met the criteria for major depression in the absence of immediate treatment. In addition to diagnostic status, we assess severity of depression and hopelessness using a number of interview and self-report measures including the Hamilton Rating Scale for Depression, the Beck Depression Inventory and the Beck Hopelessness Scale, at all time points. These quantitative measures complement the dichotomised outcome of diagnosis.
Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.
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Secondary outcome measure(s)
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1. Cognitive measures relevant to risk of relapse/recurrence (mindfulness, self-compassion, rumination, self discrepancy, autobiographical memory, and executive capacity) are assessed before and immediately after the treatment as well as at the end of the follow-up, and will be used in an explanatory analysis to examine factors that mediate and moderate efficacy
2. Severity of suicidal ideation/behaviour both within and between episodes of depression during the follow-up period
Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 067797)
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Trial website
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Publications
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2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20302615
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Contact name
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Prof
Mark
Williams
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Address
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Department of Psychiatry
University of Oxford
Warneford Hospital
Warneford Lane
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7JX
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Country
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United Kingdom
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Sponsor
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University of Oxford (UK)
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Address
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Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DZ
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Country
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United Kingdom
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Sponsor website:
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http://www.ox.ac.uk/
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Date applied
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04/01/2010
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Last edited
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25/05/2010
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Date ISRCTN assigned
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05/01/2010
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