International Deprexis Trial in Multiple Sclerosis (IDEMS) – a Multicenter Randomized Controlled Trial
Sponsor:
Brief Summary:
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.
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
Locations
- Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
