title: Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial.
abstract: BACKGROUND
  Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy.
  
  
  METHODS
  This study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse.
  
  
  CONCLUSIONS
  The clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in outpatient services.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02278224 , registered 28 Oct. 2014.
authors.affiliation: Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen K, Denmark. morten.hvenegaard@psy.ku.dk.
authors.forename: Morten
authors.initials: M
authors.lastname: Hvenegaard
authors.affiliation: School of Psychology, University of Exeter, Sir Henry Wellcome Building for Mood Disorders Research, Streatham Campus, Perry Road, Exeter, EX4 4QG, UK. e.r.watkins@exeter.ac.uk.
authors.forename: Ed R
authors.initials: ER
authors.lastname: Watkins
authors.affiliation: Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen K, Denmark. stig.poulsen@psy.ku.dk.
authors.forename: Stig
authors.initials: S
authors.lastname: Poulsen
authors.affiliation: Psychiatric Outpatient Clinic of Copenhagen, Psychiatric Hospital of The Capital Region, Nannasgade 28, 2200, Copenhagen N, Denmark. nicole.rosenberg@regionh.dk.
authors.forename: Nicole K
authors.initials: NK
authors.lastname: Rosenberg
authors.affiliation: Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen K, Denmark. matthias.gondan@psy.ku.dk.
authors.forename: Matthias
authors.initials: M
authors.lastname: Gondan
authors.affiliation: Centre for the Advancement of Research in Emotion, School of Psychology, University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009, Australia. ben.grafton@uwa.edu.au.
authors.forename: Ben
authors.initials: B
authors.lastname: Grafton
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, Copenhagen University, Dyrehavehavevej 48, 3400, Hillerød, Denmark. stephen.01.austin@regionh.dk.
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Austin
authors.affiliation: Mental Health Centre for Child and Adolescent Psychiatry, Bispebjerg Bakke 30, 2400, Copenhagen, NV, Denmark. henriette.howard.holm@regionh.dk.
authors.forename: Henriette
authors.initials: H
authors.lastname: Howard
authors.affiliation: Psychiatric Research Unit, Mental Health Centre North Zealand, Copenhagen University, Dyrehavehavevej 48, 3400, Hillerød, Denmark. stine.bjerrum.moeller@regionh.dk.
authors.forename: Stine B
authors.initials: SB
authors.lastname: Moeller
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003718:Denmark; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004644:Emotions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult