Abstract
BackgroundPsychological 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.MethodsThe 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.DiscussionThis 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.Trial RegistrationThe trial is registered through the German Clinical Trials Register (www.drks.de) as DRKS00008001. Registered 6 May 2015.
Highlights
Introduction tometacognitive training (MCT)+Information about MCT+ and the main therapeutic strategies are discussed
Aims of the trial The primary aim of this study is to investigate the effectiveness of MCT+ versus computerized cognitive remediation (CR; MyBrainTraining©) in individuals with psychosis
Given previous mixed results regarding improvement in jumping to conclusions [30, 51], we hypothesize that data gathering will improve in both groups, but that only improvement in the MCT+ group will be significantly associated with improvement in delusions (Q3)
Summary
Introduction toMCT+Information about MCT+ and the main therapeutic strategies are discussed. 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. While therapists and family members identify positive symptoms as a main treatment goal, patients tend to prioritize rather quality of life and affective symptoms [(Moritz S, Berna F, Jaeger S, Westermann S, Nagel M. There is need for effective low-intensity interventions, which can increase treatment accessibility for patients with psychosis [18]
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