title: Investigating the efficacy of an individualized metacognitive therapy program (MCT+) for psychosis: study protocol of a multi-center randomized controlled trial.
abstract: BACKGROUND
  Psychological interventions are increasingly recommended as adjunctive treatments for psychosis, but their implementation in clinical practice is still insufficient. The individualized metacognitive therapy program (MCT+; www.uke.de/mct_plus ) represents a low-threshold psychotherapeutic approach that synthesizes group metacognitive training (MCT) and cognitive behavioral therapy for psychosis, and addresses specific cognitive biases that are involved in the onset and maintenance of psychosis. It aims to "plant the seed of doubt" regarding rigid delusional convictions and to encourage patients to critically reflect, extend and change their approach to problem solving. Its second edition also puts more emphasis on affective symptoms. A recent meta-analysis of metacognitive interventions (MCT, MCT+) indicate small to moderate effects on positive symptoms and delusions, as well as high rates of acceptance. Nonetheless, no long-term studies of MCT+ involving large samples have been conducted.
  
  
  METHODS
  The goal of the present multi-center, observer-blind, parallel-group, randomized controlled trial is to compare the efficacy of MCT+ against an active control (cognitive remediation; MyBrainTraining(©)) in 328 patients with psychosis at three time points (baseline, immediately after intervention [6 weeks] and 6 months later). The primary outcome is change in psychosis symptoms over the 6-month follow-up period as assessed by the delusion subscale of the Psychotic Symptom Rating Scale. Secondary outcomes include jumping to conclusions, other positive symptoms of schizophrenia, depressive symptoms, self-esteem, quality of life, and cognitive insight. The study also seeks to elucidate mediating factors that promote versus impede symptom improvement across time.
  
  
  CONCLUSIONS
  This is the first multi-center randomized controlled trial to test the efficacy of individualized MCT+ in a large sample of patients with psychosis. The rationale for the trial, the design, and the strengths and limitations of the study are discussed.
  
  
  BACKGROUND
  The trial is registered through the German Clinical Trials Register ( www.drks.de ) as DRKS00008001 . Registered 6 May 2015.
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. b.schneider@uke.de.
authors.forename: Brooke C
authors.initials: BC
authors.lastname: Schneider
authors.affiliation: LWL University Hospital Bochum, Department of Psychiatry, Psychotherapy and Preventative Medicine, Division of Cognitive Neuropsychiatry and Psychiatric Preventative Medicine, Ruhr-University Bochum, Bochum, Germany. martin.bruene@ruhr-uni-bochum.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Brüne
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. f.bohn@uke.de.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bohn
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. r.veckenstedt@uke.de.
authors.forename: Ruth
authors.initials: R
authors.lastname: Veckenstedt
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.kolbeck@uke.de.|Department of Psychiatry and Psychotherapy, Asklepios North-Wandsbek, Hamburg, Germany. k.kolbeck@uke.de.
authors.forename: Katharina
authors.initials: K
authors.lastname: Kolbeck
authors.affiliation: Department of Psychiatry and Psychotherapy, Asklepios North-Wandsbek, Hamburg, Germany. ev.krieger@asklepios.com.
authors.forename: Eva
authors.initials: E
authors.lastname: Krieger
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. anna.becker@zi-mannheim.de.
authors.forename: Anna
authors.initials: A
authors.lastname: Becker
authors.affiliation: LWL University Hospital Bochum, Department of Psychiatry, Psychotherapy and Preventative Medicine, Division of Cognitive Neuropsychiatry and Psychiatric Preventative Medicine, Ruhr-University Bochum, Bochum, Germany. kim-alisha.drommelschmidt@lwl.org.
authors.forename: Kim Alisha
authors.initials: KA
authors.lastname: Drommelschmidt
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. susanne.englisch@zi-mannheim.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Englisch
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. sarah.eisenacher@zi-mannheim.de.
authors.forename: Sarah
authors.initials: S
authors.lastname: Eisenacher
authors.affiliation: LWL University Hospital Bochum, Department of Psychiatry, Psychotherapy and Preventative Medicine, Division of Cognitive Neuropsychiatry and Psychiatric Preventative Medicine, Ruhr-University Bochum, Bochum, Germany. sie-in.lee-grimm@lwl.org.
authors.forename: Sie-In
authors.initials: SI
authors.lastname: Lee-Grimm
authors.affiliation: Department of Psychiatry and Psychotherapy, Asklepios North-Wandsbek, Hamburg, Germany. ma.nagel@asklepios.com.|Department of Psychiatry and Psychotherapy, University of Lübeck, Lübeck, Germany. ma.nagel@asklepios.com.
authors.forename: Matthias
authors.initials: M
authors.lastname: Nagel
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. mathias.zink@zi-mannheim.de.
authors.forename: Mathias
authors.initials: M
authors.lastname: Zink
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. moritz@uke.de.
authors.forename: Steffen
authors.initials: S
authors.lastname: Moritz
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003702:Delusions / Q000523:psychology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D057285:Precision Medicine / Q000379:methods*; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome