Karolina Leopold1,2, Michael Bauer1, Andreas Bechdolf2,3, Christoph U Correll4,5,6,7, Martin Holtmann8, Georg Juckel9, Martin Lambert10, Thomas D Meyer11, Steffi Pfeiffer1, Sarah Kittel-Schneider12,13, Andreas Reif12,13, Thomas J Stamm14,15, Maren Rottmann-Wolf1, Josephine Mathiebe1, Eva L Kellmann1, Philipp Ritter1, Seza Krüger-Özgürdal9, Anne Karow10, Lene-Marie Sondergeld14,15, Veit Roessner16, Cathrin Sauer1, Andrea Pfennig1. 1. Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany. 2. Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum Am Urban, Berlin, Germany. 3. Department of Psychiatry and Psychotherapy, University Hospital Cologne, University Cologne, Köln, Germany. 4. Psychiatry and Molecular Medicine Hofstra Northwell School of Medicine, Hempstead, NY, USA. 5. Center for Psychiatric Neuroscience Feinstein Institute for Medical Research, Manhasset, NY, USA. 6. Department of Psychiatry, Recognition and Prevention (RAP) Program, The Zucker Hillside Hospital, Long Island, USA. 7. Department of Child and Adolescent Psychiatry and Psychotherapy, Charité Universitätsmedizin Berlin, Berlin, Germany. 8. Department of Child and Adolescent Psychiatry and Psychotherapy, LWL-University Hospital Hamm, Ruhr-University, Bochum, Germany. 9. Department of Psychiatry and Psychotherapy, LWL- University Hospital Bochum, Ruhr-University, Bochum, Germany. 10. Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 11. Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas HSC at Houston, Houston, TX, USA. 12. Department of Psychiatry and Psychotherapy, University Hospital Würzburg, Würzburg, Germany. 13. Department of Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Frankfurt, Germany. 14. Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin Berlin, Berlin, Germany. 15. Department of Psychiatry, Psychotherapy and Psychosomatic, Medical School Brandenburg, Neuruppin, Germany. 16. Department of Child and Adolescent Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.
Abstract
OBJECTIVE: Most patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode. Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI) require effective and safe treatment. Cognitive-behavioral psychotherapy (CBT) has shown promising results in early stages of BD and in patients at high risk for psychosis. We aimed to investigate whether group CBT can improve symptoms and functional deficits in young patients at risk for SMI presenting with subthreshold bipolar symptoms. METHOD: In a multicenter, randomized, controlled trial, patients at clinical risk for SMI presenting with subthreshold bipolar symptomsaged 15-30 years were randomized to 14 weeks of at-risk for BD-specific group CBT or unstructured group meetings. Primary efficacy endpoints were differences in affective symptomatology and psychosocial functioning at 14 weeks. At-risk status was defined as a combination of subthreshold bipolar symptomatology, reduction of psychosocial functioning and a family history for (schizo)affective disorders. A prespecified interim analysis was conducted at 75% of the targeted sample. RESULTS: Of 128 screened participants, 75 were randomized to group CBT (n = 38, completers = 65.8%) vs unstructured group meetings (n = 37, completers = 78.4%). Affective symptomatology and psychosocial functioning improved significantly at week 14 (P < .001) and during 6 months (P < .001) in both groups, without significant between-group differences. Findings are limited by the interim character of the analysis, the use of not fully validated early detection interviews, a newly adapted intervention manual, and the substantial drop-outs. CONCLUSIONS: Results suggest that young patients at-risk for SMI presenting with subthreshold bipolar symptoms benefit from early group sessions. The degree of specificity and psychotherapeutic interaction needed requires clarification.
RCT Entities:
OBJECTIVE: Most patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode. Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI) require effective and safe treatment. Cognitive-behavioral psychotherapy (CBT) has shown promising results in early stages of BD and in patients at high risk for psychosis. We aimed to investigate whether group CBT can improve symptoms and functional deficits in young patients at risk for SMI presenting with subthreshold bipolar symptoms. METHOD: In a multicenter, randomized, controlled trial, patients at clinical risk for SMI presenting with subthreshold bipolar symptoms aged 15-30 years were randomized to 14 weeks of at-risk for BD-specific group CBT or unstructured group meetings. Primary efficacy endpoints were differences in affective symptomatology and psychosocial functioning at 14 weeks. At-risk status was defined as a combination of subthreshold bipolar symptomatology, reduction of psychosocial functioning and a family history for (schizo)affective disorders. A prespecified interim analysis was conducted at 75% of the targeted sample. RESULTS: Of 128 screened participants, 75 were randomized to group CBT (n = 38, completers = 65.8%) vs unstructured group meetings (n = 37, completers = 78.4%). Affective symptomatology and psychosocial functioning improved significantly at week 14 (P < .001) and during 6 months (P < .001) in both groups, without significant between-group differences. Findings are limited by the interim character of the analysis, the use of not fully validated early detection interviews, a newly adapted intervention manual, and the substantial drop-outs. CONCLUSIONS: Results suggest that young patients at-risk for SMI presenting with subthreshold bipolar symptoms benefit from early group sessions. The degree of specificity and psychotherapeutic interaction needed requires clarification.
Authors: Paolo Fusar-Poli; Christoph U Correll; Celso Arango; Michael Berk; Vikram Patel; John P A Ioannidis Journal: World Psychiatry Date: 2021-06 Impact factor: 79.683
Authors: Pavol Mikolas; Kyra Bröckel; Christoph Vogelbacher; Dirk K Müller; Michael Marxen; Christina Berndt; Cathrin Sauer; Stine Jung; Juliane Hilde Fröhner; Andreas J Fallgatter; Thomas Ethofer; Anne Rau; Tilo Kircher; Irina Falkenberg; Martin Lambert; Vivien Kraft; Karolina Leopold; Andreas Bechdolf; Andreas Reif; Silke Matura; Thomas Stamm; Felix Bermpohl; Jana Fiebig; Georg Juckel; Vera Flasbeck; Christoph U Correll; Philipp Ritter; Michael Bauer; Andreas Jansen; Andrea Pfennig Journal: Transl Psychiatry Date: 2021-09-20 Impact factor: 6.222
Authors: Julia Martini; Karolina Leopold; Steffi Pfeiffer; Christina Berndt; Anne Boehme; Veit Roessner; Paolo Fusar-Poli; Allan H Young; Christoph U Correll; Michael Bauer; Andrea Pfennig Journal: Int J Bipolar Disord Date: 2021-07-02