staying well after depression trial design and protocol住后抑郁试验设计和协议.pdf
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Williams et al. BMC Psychiatry 2010, 10:23
/1471-244X/10/23
STUDY PROTOCOL Open Access
Staying well after depression: trial design and
protocol
1* 2,3 1 3 3 1
J Mark G Williams , Ian T Russell , Catherine Crane , Daphne Russell , Chris J Whitaker , Danielle S Duggan ,
1 1 4 4
Thorsten Barnhofer , Melanie JV Fennell , Rebecca Crane , Sarah Silverton
Abstract
Background: Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have
been depressed before. This is particularly problematic for those who become suicidal when depressed since
habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the
question how to prevent relapse is of particular urgency in this group.
Methods/Design: This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment
combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education
(CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test
whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms
in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main
inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility
in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU
alone in a ratio of 2:2:1, stratified by presence of suicidal ideation
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