Anja Fischer1, Johanna Schröder2, Eik Vettorazzi3, Oliver T Wolf4, Jana Pöttgen5, Stephanie Lau5, Christoph Heesen6, Steffen Moritz2, Stefan M Gold7. 1. Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 2. Department of Psychiatry and Psychotherapy, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 3. Department of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 4. Department of Cognitive Psychology, Ruhr-University, Bochum, Germany. 5. Department of Neurology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 6. Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Neurology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 7. Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Medical Psychology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: stefan.gold@zmnh.uni-hamburg.de.
Abstract
BACKGROUND: With a lifetime risk for major depressive disorder of up to 50%, depression is a common comorbidity in multiple sclerosis but remains widely underdiagnosed and untreated. We investigated the potential of a fully automated, internet-based, cognitive behavioural therapy programme, Deprexis, to reduce depressive symptoms in patients with multiple sclerosis. METHODS: For this randomised controlled trial, we recruited patients from an outpatient clinic in Hamburg, Germany. Patients aged 18-65 years were eligible for inclusion if they had multiple sclerosis and self-reported depressive symptoms. By use of a computer-generated randomisation sequence, we allocated 90 patients (1:1; no blocking or stratification) to either the intervention group or a waitlist control group for 9 weeks. The primary endpoint was the Beck Depression Inventory (BDI), as assessed by an intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT01663649. FINDINGS:71 patients completed the trial: 35 patients in the intervention group and 36 patients in the control group. During the intervention, BDI scores decreased in the Deprexis group and increased in the control group, yielding a positive effect of Deprexis relative to the waitlist group (mean group difference -4·02 points [95% CI -7·26 to -0·79], p=0·015, effect size d=0·53). Worsening of depressive symptoms from below to above the clinical cutoff (BDI >13) occurred in three (7%) of 45 patients in the control group and no patients in the Deprexis group. We noted no adverse events with respect to new occurrence of suicidal ideation during the trial. INTERPRETATION:Psychological online-intervention programmes could be suitable for patients with multiple sclerosis who are unable to regularly attend therapeutic sessions because of mobility impairments. FUNDING: European Union and the Deutsche Forschungsgemeinschaft.
RCT Entities:
BACKGROUND: With a lifetime risk for major depressive disorder of up to 50%, depression is a common comorbidity in multiple sclerosis but remains widely underdiagnosed and untreated. We investigated the potential of a fully automated, internet-based, cognitive behavioural therapy programme, Deprexis, to reduce depressive symptoms in patients with multiple sclerosis. METHODS: For this randomised controlled trial, we recruited patients from an outpatient clinic in Hamburg, Germany. Patients aged 18-65 years were eligible for inclusion if they had multiple sclerosis and self-reported depressive symptoms. By use of a computer-generated randomisation sequence, we allocated 90 patients (1:1; no blocking or stratification) to either the intervention group or a waitlist control group for 9 weeks. The primary endpoint was the Beck Depression Inventory (BDI), as assessed by an intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT01663649. FINDINGS: 71 patients completed the trial: 35 patients in the intervention group and 36 patients in the control group. During the intervention, BDI scores decreased in the Deprexis group and increased in the control group, yielding a positive effect of Deprexis relative to the waitlist group (mean group difference -4·02 points [95% CI -7·26 to -0·79], p=0·015, effect size d=0·53). Worsening of depressive symptoms from below to above the clinical cutoff (BDI >13) occurred in three (7%) of 45 patients in the control group and no patients in the Deprexis group. We noted no adverse events with respect to new occurrence of suicidal ideation during the trial. INTERPRETATION: Psychological online-intervention programmes could be suitable for patients with multiple sclerosis who are unable to regularly attend therapeutic sessions because of mobility impairments. FUNDING: European Union and the Deutsche Forschungsgemeinschaft.
Authors: Aaron P Turner; Kevin N Alschuler; Abbey J Hughes; Meghan Beier; Jodie K Haselkorn; Alicia P Sloan; Dawn M Ehde Journal: Curr Neurol Neurosci Rep Date: 2016-12 Impact factor: 5.081
Authors: Jan Philipp Klein; Thomas Berger; Johanna Schröder; Christina Späth; Björn Meyer; Franz Caspar; Wolfgang Lutz; Alice Arndt; Wolfgang Greiner; Viola Gräfe; Martin Hautzinger; Kristina Fuhr; Matthias Rose; Sandra Nolte; Bernd Löwe; Gerhard Anderssoni; Eik Vettorazzi; Steffen Moritz; Fritz Hohagen Journal: Psychother Psychosom Date: 2016-05-27 Impact factor: 17.659