Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial
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STUDY PROTOCOL
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Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial Thomas J. Stamm1,2*† , Julia C. Zwick3†, Grace O’Malley1, Lene-Marie Sondergeld1 and Martin Hautzinger3
Abstract Background: Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder. Methods: In this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or EmotionFocused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest. Discussion: The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder. Trial registration: USA: ClinicalTrials.gov NCT02506322. Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013. Registered on21 May 2015 Keywords: Bipolar disorder, Group psychotherapy, CBT, RCT, Early intervention
* Correspondence: [email protected] † Thomas J. Stamm and Julia C. Zwick contributed equally to this work. 1 Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany 2 Department of Psychiatry and Psychotherapy, Charité University Medicine, Berlin, Germany Full list of author information is available at the end of the article
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