Multiple Sclerosis Clinical Trial
Official title:
International Deprexis Trial in Multiple Sclerosis (IDEMS) - a Multicenter Randomized Controlled Trial
Verified date | July 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an international, multicenter, randomized controlled trial of an internet-based CBT intervention for depression (Deprexis) conducted in five MS centers in the US and Germany. The trial consists of a three-arm primary trial phase and an extension phase targeted at maintenance.
Status | Active, not recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria - age > 18 - neurologist-confirmed diagnosis of MS (all forms) - self-reported depressive symptoms (BDI-Fastscreen > 4) - fluent in German or English (depending on study site), - willingness to engage in self-administration of an iCBT intervention for 3 months and complete follow-up - ability to travel to the outpatient center for two clinical assessments (baseline and month 3) - internet access at home Exclusion criteria: - unwilling or unable to consent, - diagnosis of bipolar or psychosis (as determined by M.I.N.I structured interview), - substantial neurocognitive impairments such as dementia or autism - moderate or high risk of suicide (according to MINI module C) or by clinical impression - very severe depression that would interfere with the ability to participate in the study (based on clinical judgment by the physician at the recruitment site). - current psychotherapy/behavioral treatments for depression - started pharmacotherapy for depression within the last 2 months - MS relapse or steroid treatment in the last 4 weeks - concurrent participation in another clinical trial that includes an intervention - refusal to saving, processing and forwarding of pseudonymized data |
Country | Name | City | State |
---|---|---|---|
Germany | Charité University | Berlin | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
United States | University of Missouri, Kansas City | Kansas City | Kansas |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Penn State University | State College | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Cedars-Sinai Medical Center, King's College London, National Multiple Sclerosis Society, NeuroCure Clinical Research Center, Charite, Berlin, Penn State University, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Goettingen, University of Missouri, Kansas City |
United States, Germany,
Fischer A, Schröder J, Vettorazzi E, Wolf OT, Pöttgen J, Lau S, Heesen C, Moritz S, Gold SM. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015 Mar;2(3):217-23. doi: 10.1016/S2215-0366(14)00049-2. Epub 2015 Feb 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) | Consists of 3 subtests. 1. SMDT (total score), CVLT-II (2 scores: learning score and delayed recall), and BVMT-R (2 scores: learning score and delayed recall) | Month 0 to Month 3 | |
Other | Suicide Behaviors Questionnaire-Revised (SBQ-R) | Month 3 | ||
Other | Mini International Neuropsychiatric Interview, clinician rating, Version 5.0.0 | Dichotomous variable "Major Depressive Episode, Current (yes/no)" according to module A of the MINI. | Month 0 to Month 3 | |
Primary | Beck Depression Inventory-II | Month 0 to Month 3 | ||
Secondary | WHO Quality of Life scale (WHO-QOL BREF) | 4 subscales (Physical, Psychological, Social Relationships, Environmental) | Month 0 to Month 3 | |
Secondary | Multiple Sclerosis Impact Scale (MSIS) | 2 subscales (Physical and Psychological) | Month 0 to Month 3 | |
Secondary | Fatigue Scale for Motor and Cognitive Functions (FSMC) | Total score and 2 subscales (Motor and Cognitive) | Month 0 to Month 3 | |
Secondary | Chalder Fatigue Scale | Month 0 to Month 3 |
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