International Deprexis Trial in Multiple Sclerosis (IDEMS) - a Multicenter Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT02740361

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Deprexis, DeprexisPlus

What it measured

Main measures

  • Beck Depression Inventory-II

    Month 0 to Month 3

    Mood and sleep

Other measures (4)

  • WHO Quality of Life scale (WHO-QOL BREF)

    Month 0 to Month 3

    Quality of life (reported by participants)
  • Multiple Sclerosis Impact Scale (MSIS)

    Month 0 to Month 3

    Quality of life (reported by participants)
  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Month 0 to Month 3

    Thinking and memoryFatigue
  • Chalder Fatigue Scale

    Month 0 to Month 3

    Fatigue

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2017

    2. Main results due

      Jan 2021

    3. Finished

      May 2021

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