NCT02740361

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

April 12, 2016

Last Update Submit

May 15, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory-II

    Month 0 to Month 3

Secondary Outcomes (4)

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

    Month 0 to Month 3

  • Multiple Sclerosis Impact Scale (MSIS)

    Month 0 to Month 3

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Month 0 to Month 3

  • Chalder Fatigue Scale

    Month 0 to Month 3

Other Outcomes (3)

  • Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

    Month 0 to Month 3

  • Suicide Behaviors Questionnaire-Revised (SBQ-R)

    Month 3

  • Mini International Neuropsychiatric Interview, clinician rating, Version 5.0.0

    Month 0 to Month 3

Study Arms (3)

Deprexis

EXPERIMENTAL

This group will receive access to the web-based Deprexis program, an online tool based on principles of cognitive behavioral therapy. Contents include (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving, (8) expressive writing and forgiveness, (9) positive psychology, and (10) emotion-focused interventions.

Behavioral: Deprexis, DeprexisPlus

DeprexisPlus

EXPERIMENTAL

This group will receive the web-based Deprexis program (see above) plus scheduled e-mail contact (1x/week)

Behavioral: Deprexis, DeprexisPlus

Waitlist Control

NO INTERVENTION

Participants randomized to the control group will wait for access to the Deprexis program (waitlist control) for 6 months. After the 6-month waiting period, participants in this group will have full access to Deprexis.

Interventions

Deprexis, DeprexisPlusBEHAVIORAL

Online program Deprexis, either as a stand-alone internet-based intervention (Deprexis) or with added standardized email support by a clinical psychologist (DeprexisPlus). In this trial, we will use a Version of Deprexis that has been adapted to MS-specific needs.

DeprexisDeprexisPlus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Missouri, Kansas City

Kansas City, Kansas, 66103, United States

Location

Penn State University

State College, Pennsylvania, 16801, United States

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Charité University

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • Gold SM, Friede T, Meyer B, Moss-Morris R, Hudson J, Asseyer S, Bellmann-Strobl J, Leisdon A, Issels L, Ritter K, Schymainski D, Pomeroy H, Lynch SG, Cozart JS, Thelen J, Roman CAF, Cadden M, Guty E, Lau S, Pottgen J, Ramien C, Seddiq-Zai S, Kloidt AM, Wieditz J, Penner IK, Paul F, Sicotte NL, Bruce JM, Arnett PA, Heesen C. Internet-delivered cognitive behavioural therapy programme to reduce depressive symptoms in patients with multiple sclerosis: a multicentre, randomised, controlled, phase 3 trial. Lancet Digit Health. 2023 Oct;5(10):e668-e678. doi: 10.1016/S2589-7500(23)00109-7.

    PMID: 37775187BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Stefan M Gold, PhD

    Charité University, Berlin

    STUDY DIRECTOR

  • Friedemann Paul, MD

    Charité University, Berlin

    PRINCIPAL INVESTIGATOR

  • Christoph Heesen, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Nancy Sicotte, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Jared Bruce, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

  • Sharon Lynch, MD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

  • Peter Arnett, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Rona Moss-Morris, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

  • Tim Friede, PhD

    University Medical Center Goettingen

    PRINCIPAL INVESTIGATOR

  • Björn Meyer, PhD

    GAIA Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 15, 2016

Study Start

February 15, 2017

Primary Completion

January 30, 2021

Study Completion

May 1, 2021

Last Updated

May 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Anonymized individual data on the primary endpoint will be published alongside the trial report in a peer reviewed journal.

Locations

DE(2)US(3)